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This part of ISO 80369 specifies requirements for SMALL-BORE CONNECTORS intended to be used for CONNECTIONS in neuraxial APPLICATIONS. Neuraxial APPLICATIONS involve the use of MEDICAL DEVICES intended to administer medications to neuraxial sites, wound infiltration anaesthesia delivery, and other regional anaesthesia procedures or to monitor or remove cerebro-spinal fluid for therapeutic or diagnostic purposes.This part of ISO 80369 specifies dimensions and requirements for the design and functional performance of these SMALL-BORE CONNECTORS intended to be used with MEDICAL DEVICES. This part of ISO 80369 does not specify requirements for the MEDICAL DEVICES or ACCESSORIES that use these CONNECTORS. Such requirements are given in particular International Standards for specific MEDICAL DEVICES or ACCESSORIES.
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© ISO 2014
ISO/CEN PARALLEL PROCESSINGThis draft has been developed within the International Organization for Standardization (ISO), and processed under the ISO lead mode of collaboration as defined in the Vienna Agreement.
This draft is hereby submitted to the ISO member bodies and to the CEN member bodies for a parallel five month enquiry.
Should this draft be accepted, a final draft, established on the basis of comments received, will be submitted to a parallel two-month approval vote in ISO and formal vote in CEN.
To expedite distribution, this document is circulated as received from the committee secretariat. ISO Central Secretariat work of editing and text composition will be undertaken at publication stage.
Small bore connectors for liquids and gases in healthcare applications —Part 6: Connectors for neuraxial applicationsRaccords de petite taille pour liquides et gaz utilisés dans le domaine de la santé —Partie 6: Raccords destinés à des applications neuraxiales
Reference numberISO/DIS 80369-6:2014(E)
DRAFT INTERNATIONAL STANDARDISO/DIS 80369-6
THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS THEREFORE SUBJECT TO CHANGE AND MAY NOT BE REFERRED TO AS AN INTERNATIONAL STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL, TECHNOLOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT INTERNATIONAL STANDARDS MAY ON OCCASION HAVE TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL TO BECOME STANDARDS TO WHICH REFERENCE MAY BE MADE IN NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT, WITH THEIR COMMENTS, NOTIFICATION OF ANY RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE AND TO PROVIDE SUPPORTING DOCUMENTATION.
ISO/TC 210 Voting begins on:
2014-09-04
Secretariat: ANSI Voting terminates on: 2015-02-04
ICS: 11.040.25
ISO/DIS 80369-6:2014(E)
ii © ISO 2014 – All rights reserved
Copyright notice
This ISO document is a Draft International Standard and is copyright-protected by ISO. Except as permitted under the applicable laws of the user’s country, neither this ISO draft nor any extract from it may be reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic, photocopying, recording or otherwise, without prior written permission being secured.
Requests for permission to reproduce should be addressed to either ISO at the address below or ISO’s member body in the country of the requester.
ISO copyright officeCase postale 56 • CH-1211 Geneva 20Tel. + 41 22 749 01 11Fax + 41 22 749 09 47E-mail [email protected] www.iso.org
Reproduction may be subject to royalty payments or a licensing agreement.
Violators may be prosecuted.
ISO/IEC DIS 80369-6
© ISO/IEC 2014 – All rights reserved iii
Contents Page 1
Foreword ........................................................................................................................................................ iv 2
Introduction .................................................................................................................................................... vi 3
1 Scope .................................................................................................................................................. 1 4
2 Normative references ......................................................................................................................... 1 5
3 Terms and definitions ........................................................................................................................ 2 6
4 General requirements ........................................................................................................................ 3 7
4.1 General requirements for the neuraxial APPLICATION ........................................................................ 3 8
4.2 Material used for SMALL-BORE CONNECTORS ....................................................................................... 4 9
4.3 Compatibility ...................................................................................................................................... 4 10
4.3.1 Compatibility with substances used................................................................................................. 4 11
4.3.2 Biocompatibility ................................................................................................................................. 4 12
5 Dimensional requirements for SMALL-BORE CONNECTORS for neuraxial APPLICATIONS ..................... 4 13
6 Performance requirements ................................................................................................................ 4 14
6.1 General performance requirements .................................................................................................. 4 15
6.2 Fluid leakage ...................................................................................................................................... 5 16
6.2.1 Fluid leakage requirement ................................................................................................................. 5 17
6.2.2 Leakage by pressure decay .............................................................................................................. 5 18
6.2.3 Positive pressure liquid leakage ....................................................................................................... 5 19
6.3 Subatmospheric-pressure air leakage .............................................................................................. 5 20
6.4 Stress cracking .................................................................................................................................. 5 21
6.5 Resistance to separation from axial load ......................................................................................... 5 22
6.6 Resistance to separation from unscrewing ..................................................................................... 6 23
6.7 Resistance to overriding ................................................................................................................... 6 24
Annex A (informative) Rationale and guidance ............................................................................................. 7 25
ANNEX B (normative) * SMALL-BORE CONNECTORS for neuraxial APPLICATIONS ............................................. 11 26
ANNEX C (normative) Reference CONNECTORS for testing SMALL-BORE CONNECTORS for neuraxial 27
APPLICATIONS ...................................................................................................................................... 21 28
Annex D (informative) Assessment of MEDICAL DEVICES and their attributes with CONNECTIONS within 29
this APPLICATION ................................................................................................................................ 27 30
ANNEX E (informative) Summary of the usability requirements for SMALL-BORE CONNECTORS for 31
neuraxial APPLICATIONS ..................................................................................................................... 29 32
Annex F (informative) Summary of SMALL-BORE CONNECTOR criteria and requirements for neuraxial 33
APPLICATIONS ...................................................................................................................................... 33 34
ANNEX G (informative) Summary of assessment of the design of the SMALL BORE CONNECTORS for 35
neuraxial APPLICATIONS ..................................................................................................................... 35 36
Annex H (informative) Mechanical tests for verifying NON-INTERCONNECTABLE characteristics ................ 41 37
Annex I (informative) Reference to the Essential Principles ...................................................................... 44 38
Bibliography .................................................................................................................................................. 46 39
Terminology - Alphabetized index of defined terms .................................................................................. 48 40
Annex ZA (informative) Relationship between this Document and the Essential Requirements of EU 41
Directive 93/42/EEC .......................................................................................................................... 49 42
43
ISO/IEC DIS 80369-6
iv © ISO/IEC 2014 – All rights reserved
Foreword 44
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies 45
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO 46
technical committees. Each member body interested in a subject for which a technical committee has been 47
established has the right to be represented on that committee. International organizations, governmental and 48
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International 49
Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. 50
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. 51
The main task of technical committees is to prepare International Standards. Draft International Standards 52
adopted by the technical committees are circulated to the member bodies for voting. Publication as an 53
International Standard requires approval by at least 75 % of the member bodies casting a vote. 54
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent 55
rights. ISO shall not be held responsible for identifying any or all such patent rights. 56
ISO/IEC 80369-6 was prepared by a Joint Working Group of Technical Committee ISO/TC 210, Quality 57
management and corresponding general aspects for medical devices, IEC/TC 62, Electrical equipment, 58
Subcommittee (SC) D, Electrical equipment in medical practice and CEN/CENELEC TC3/WG 2, Small-bore 59
connectors. 60
This is the first edition of ISO 80369-6. 61
ISO/IEC 80369 consists of the following parts, under the general title Small-bore connectors for liquids and gases 62
in healthcare applications: 63
Part 1: General requirements 64
Part 2: Connectors for breathing systems and driving gases applications 65
Part 3: Connectors for enteral applications 66
Part 4: Connectors for urethral and urinary applications1) 67
Part 5: Connectors for limb cuff inflation applications 68
Part 6: Connectors for neuraxial applications (this standard) 69
Part 7: Connectors with 6% (Luer) taper for intravascular or hypodermic applications 70
In this standard, the following print types are used: 71
Requirements and definitions: roman type. 72
Informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text 73
of tables is also in a smaller type. 74
1) Planned but not yet begun as of the date of publication.
ISO/IEC DIS 80369-6
© ISO/IEC 2014 – All rights reserved v
TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL 75
CAPITALS. 76
In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of the 77
conditions is true. 78
The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives, Part 2. 79
For the purposes of this standard, the auxiliary verb: 80
“shall” means that compliance with a requirement or a test is mandatory for compliance with this standard; 81
“should” means that compliance with a requirement or a test is recommended but is not mandatory for 82
compliance with this standard; 83
“may” is used to describe a permissible way to achieve compliance with a requirement or test. 84
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that there is 85
guidance or rationale related to that item in Annex A. 86
The attention of Member Bodies and National Committees is drawn to the fact that equipment manufacturers and 87
testing organizations may need a transitional period following publication of a new, amended or revised ISO or 88
IEC publication in which to make products in accordance with the new requirements and to equip themselves for 89
conducting new or revised tests. It is the recommendation of the committees that the content of this publication 90
be adopted for implementation nationally not earlier than 3 years from the date of publication for equipment newly 91
designed and not earlier than 5 years from the date of publication for equipment already in production. 92
93
ISO/IEC DIS 80369-6
vi © ISO/IEC 2014 – All rights reserved
Introduction 94
The standards in this series were developed to prevent misconnection between SMALL-BORE CONNECTORS used in 95
different APPLICATIONS. Part 1 of the series documents the necessary measures and PROCEDURES to prevent 96
misconnection and defines the APPLICATIONS. Part 20 contains the common TEST METHODS to support the 97
functional requirements for SMALL-BORE CONNECTORS. The other parts specify the designs of SMALL-BORE 98
CONNECTORS for each APPLICATION. 99
This part of ISO 80369 includes the dimensions and drawings of CONNECTORS intended to be used in neuraxial 100
APPLICATIONS. Other parts of ISO 80369 include requirements for SMALL-BORE CONNECTORS used in different 101
APPLICATION categories. 102
There is international evidence that ‘wrong-route’ medication errors with neuraxial MEDICAL DEVICES have caused 103
deaths and severe HARM. There are reports of non-epidural medications being administered into the epidural 104
space and local anaesthetic solutions intended for epidural administration being administered by the intravenous 105
route. [1][6][11][12][12][16] There is also a report where an anaesthetic agent for intravenous use was 106
administered into the cerebrospinal fluid via an external ventricular drain [7] and earlier reports of antibiotics being 107
inappropriately administered by this route. 108
In July 2007 the World Health Organisation’s World Alliance For Patient Safety issued Alert 115 describing four 109
incidents in different countries in which vincristine had been accidentally administered by the intrathecal route 110
instead of intravenous route, as intended. [20] The Alert indicated that, since 1968, this same error had been 111
reported 55 times from a variety of institutional settings. 112
These incidents had occurred despite repeated warnings of the RISK and the introduction of extensive labelling 113
requirements and recommendations, intended to standardise practice and reduce RISKS. 114
Other health organisations around the world have also issued detailed guidance to minimise the RISK of these 115
‘wrong-route’ errors. [17][12][18][6] 116
Nevertheless, reports of fatal incidents following the administration of vinca alkaloids continue to be reported 117
internationally. [19] In 2009, the Food and Drug Administration in the USA issued a Medical Devices Calendar 118
which included an example of a case study of a neuraxial misconnection. [9] 119
120
121
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© ISO/IEC 2014 – All rights reserved 1
Small-bore connectors for liquids and gases in healthcare 122
applications — Part 6: Connectors for neuraxial applications 123
1 * Scope 124
This part of ISO 80369 specifies requirements for SMALL-BORE CONNECTORS intended to be used for CONNECTIONS 125
in neuraxial APPLICATIONS. Neuraxial APPLICATIONS involve the use of MEDICAL DEVICES intended to administer 126
medications to neuraxial sites, wound infiltration anaesthesia delivery, and other regional anaesthesia procedures 127
or to monitor or remove cerebro-spinal fluid for therapeutic or diagnostic purposes. 128
NOTE 1 Sites for the NEURAXIAL APPLICATION include the spine, intrathecal or subarachnoid space, ventricles of the brain 129
and the epi-, extra-, or peri-dural space. NEURAXIAL APPLICATION anaesthetics can be administered regionally affecting a large 130
part of the body, such as a limb, and include plexus blocks, such as the branchial plexus blocks or single nerve blocks. 131
NEURAXIAL APPLICATION procedures include continuous infusion of wounds with local anaesthetic agents. 132
NOTE 2 For the purposes of this standard, local anaesthesia injected hypodermically is not considered a neuraxial 133
APPLICATION. 134
EXAMPLES Intended administration includes intrathecal chemotherapy, local anaesthetics, radiological contrast agents, 135
antibiotics, analgesics 136
This part of ISO 80369 specifies dimensions and requirements for the design and functional performance of these 137
SMALL-BORE CONNECTORS intended to be used with MEDICAL DEVICES. This part of ISO 80369 does not specify 138
requirements for the MEDICAL DEVICES or ACCESSORIES that use these CONNECTORS. Such requirements are given 139
in particular International Standards for specific MEDICAL DEVICES or ACCESSORIES. 140
NOTE 3 MANUFACTURERS are encouraged to incorporate the SMALL-BORE CONNECTORS specified in this part of ISO 80369 141
into MEDICAL DEVICES, medical systems or ACCESSORIES, even if currently not required by the relevant particular MEDICAL DEVICE 142
standards. It is expected that when the relevant particular MEDICAL DEVICE standards are revised, requirements for SMALL-BORE 143
CONNECTORS, as specified in this part of ISO 80369, will be included. Furthermore it is recognised that standards need to be 144
developed for many MEDICAL DEVICES used for neuraxial APPLICATIONS. 145
2 Normative references 146
The following referenced documents, in whole or in part, are normatively referenced in this document and are 147
indispensable for the application of this document. For dated references, only the edition cited applies. For 148
undated references, the latest edition of the referenced document (including any amendments) applies. 149
NOTE 1 The way in which these referenced documents are cited in normative requirements determines the extent (in 150
whole or in part) to which they apply. 151
NOTE 2 Informative references are listed in the bibliography on page 46. 152
ISO 10933-1:2009, Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk 153
management process 154
ISO 80369-1:2010, Small-bore connectors for liquids and gases in healthcare applications — Part 1: General 155
requirements 156
ISO/IEC DIS 80369-6
2 © ISO/IEC 2014 – All rights reserved
ISO 80369-3:— 2), Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors 157
for enteral applications 158
ISO 80369-5:— 3), Small-bore connectors for liquids and gases in healthcare applications — Part 5: Connectors 159
for limb cuff inflation applications 160
ISO 80369-7:— 4), Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors 161
with 6% (Luer) taper for intravascular or hypodermic applications 162
ISO 80369-20:— 5), Small-bore connectors for liquids and gases in healthcare applications — Part 20: Common 163
test methods 164
ASTM D638-10, Standard test method for tensile properties of plastics 165
ASTM D790-10, Standard test methods for flexural properties of unreinforced and reinforced plastics and 166
electrical insulating materials 167
3 Terms and definitions 168
For the purpose of this document, the terms and definitions specified in ISO 80369-1 ISO 80369-20:—, 169
ISO 14971:2007 and the following apply. For convenience, the sources of all defined terms used in this document 170
are given in the Index on page 48. 171
3.1 172
LOCK CONNECTOR 173
CONNECTOR with a locking mechanism 174
3.2 175
NORMAL USE 176
operation, including routine inspection and adjustments by any USER, and stand-by, according to the instructions 177
for use 178
NOTE 1 to entry: NORMAL USE should not be confused with INTENDED USE. While both include the concept of use as intended by 179
the MANUFACTURER, INTENDED USE focuses on the medical purpose while NORMAL USE incorporates not only the medical purpose, 180
but maintenance, service, transport, etc. as well. 181
[SOURCE: IEC 60601-1:2005+A1:2012, definition 3.97, modified, replaced ‘OPERATOR’ with ‘USER’.] 182
3.3 183
RATED 184
<value> term referring to a value assigned by the MANUFACTURER for a specified operating condition 185
[SOURCE: IEC 60601-1:2005, definition 3.97] 186
3.4 187
SLIP CONNECTOR 188
CONNECTOR without a locking mechanism 189
2) To be published.
3) To be published.
4) To be published.
5) To be published.
ISO/IEC DIS 80369-6
© ISO/IEC 2014 – All rights reserved 3
3.5 190
USER 191
person using, i.e. operating or handling, the MEDICAL DEVICE 192
NOTE 1 to entry: This includes, but is not limited to, cleaners, maintainers and installers. 193
NOTE 2 to entry: PATIENTS or other laypersons can be USERS. 194
[SOURCE: ISO 62366:2007, definition 3.23] 195
3.6 196
USER PROFILE 197
summary of the mental, physical and demographic traits of an intended USER population, as well as any special 198
characteristics that can have a bearing on design decisions, such as occupational skills and job requirements 199
[SOURCE: ISO 62366:2007, definition 3.25] 200
4 General requirements 201
4.1 General requirements for the neuraxial APPLICATION 202
SMALL-BORE CONNECTORS of MEDICAL DEVICES or ACCESSORIES intended for use in neuraxial APPLICATIONS 203
specified in this standard comply with the general requirements of ISO 80369-1:2010 except as follows. 204
Because the following CONNECTORS are inadequately specified, SMALL-BORE CONNECTORS for use in neuraxial 205
APPLICATIONS should not, but may connect with: 206
the cones and sockets of ISO 5356-1:2004 and ISO 5356-2:2006; 207
the temperature sensor CONNECTOR and mating ports specified in Annex DD of ISO 8185:2007; and 208
the nipples of EN 13544-2:2002, 209
The reference CONNECTORS for evaluation of the NON-INTERCONNECTABLE characteristics are described in Annex C. 210
The tests of Annex H shall replace ISO 80369-1:2010, Annex B. 211
NOTE 1 ISO 80369-6, Annex H, describes a deviation to the physical test NON-INTERCONNECTABLE characteristics of 212
ISO 80369-1, Annex B. A rationale for the deviation is provided in Annex A. For neuraxial SMALL-BORE CONNECTORS, 213
ISO 80369-6, Annex H, supersedes ISO 80369-1 Annex B. 214
Where the design of the SMALL-BORE CONNECTORS of this standard, relies on dimensions or features of the 215
MEDICAL DEVICE or ACCESSORY to ensure NON-INTERCONNECTABLE characteristics, the MANUFACTURER shall verify 216
the NON-INTERCONNECTABLE characteristics. Check compliance by application of the tests of Annex H. When 217
necessary, the SMALL-BORE CONNECTOR may be installed on the MEDICAL DEVICE or ACCESSORY to demonstrate 218
compliance with the NON-INTERCONNECTABLE requirements of Annex H. 219
NOTE 2 MEDICAL DEVICES using the SMALL-BORE CONNECTORS of this standard that do not rely on the dimensions or features 220
of the MEDICAL DEVICE or ACCESSORY to ensure NON-INTERCONNECTABLE characteristics are presumed to comply with the NON-221
INTERCONNECTABLE characteristics test requirements of this standard by virtue of testing used to create and validate this 222
standard. 223
NOTE 3 The summary of MEDICAL DEVICES and their attributes with CONNECTIONS within this APPLICATION is provided in 224
informative Annex D. 225
NOTE 4 The summary of the usability requirements for CONNECTORS for this APPLICATION is provided in informative Annex E. 226
NOTE 5 The summary of criteria and requirements for CONNECTORS for this APPLICATION is provided in informative Annex F. 227
ISO/IEC DIS 80369-6
4 © ISO/IEC 2014 – All rights reserved
NOTE 6 The summary of assessment of the design of CONNECTORS for this APPLICATION according to ISO 80369-1:2010, 228
Clause 7, is contained in informative Annex G. 229
4.2 Material used for SMALL-BORE CONNECTORS 230
In addition to the requirements of ISO 80369-1:2010, Clause 4, SMALL-BORE CONNECTORS of MEDICAL DEVICES or 231
ACCESSORIES shall be made of materials with a modulus of elasticity either in flexure or in tension greater than 232
950 MPa. 233
Check compliance by application of the tests of ASTM D638 or ASTM D790. 234
4.3 Compatibility 235
4.3.1 Compatibility with substances used 236
The material from which the SMALL-BORE CONNECTOR of MEDICAL DEVICES or ACCESSORIES is made shall be 237
compatible with the substances intended to be passed through the CONNECTOR. 238
Check compliance by inspection of the RISK MANAGEMENT FILE. 239
4.3.2 Biocompatibility 240
The SMALL-BORE CONNECTOR of MEDICAL DEVICES or ACCESSORIES shall be evaluated to the requirements of 241
ISO 10933-1:2009. 242
Check compliance by application of ISO 10933:2009. 243
5 Dimensional requirements for SMALL-BORE CONNECTORS for neuraxial APPLICATIONS 244
SMALL-BORE CONNECTORS intended to be used in the neuraxial APPLICATION shall comply with the relevant 245
dimensions and tolerances as given in 246
Figure B.1 and Table B.1 for a male SLIP CONNECTOR (N1). 247
Figure B.2 and Table B.2 for a male LOCK CONNECTOR (N2). 248
Figure B.3 and Table B.3 for a male LOCK CONNECTOR with rotatable collar (N2). 249
Figure B.4 and Table B.4 for a female CONNECTOR with swept threads (N2). 250
Figure B.5 and Table B.5 for a female CONNECTOR with lugs (N2). 251
NOTE ISO 80369-1, 5.8, specifies alternative methods of compliance with the ISO 80369 (series), for SMALL-BORE 252
CONNECTORS intended for use in the neuraxial APPLICATION, which do not comply with this International Standard. 253
Check compliance by verifying the relevant dimensions and tolerances specified in Annex B. 254
The dimensions of male and female CONNECTORS made of RIGID and SEMI-RIGID MATERIALS shall comply with the 255
relevant dimensional values given in Annex B. 256
6 Performance requirements 257
6.1 General performance requirements 258
The tests described within this International Standard are TYPE TESTS. 259
ISO/IEC DIS 80369-6
© ISO/IEC 2014 – All rights reserved 5
6.2 Fluid leakage 260
6.2.1 Fluid leakage requirement 261
Neuraxial SMALL-BORE CONNECTORS shall either be evaluated for leakage using the leakage by pressure decay 262
TEST METHOD or be evaluated for leakage using the positive pressure liquid leakage TEST METHOD. 263
6.2.2 Leakage by pressure decay 264
Neuraxial SMALL-BORE CONNECTORS evaluated for fluid leakage performance with the leakage by pressure decay 265
TEST METHOD shall not leak by more than 0,005 Pa·m3/s while being subjected to an applied pressure of between 266
300 kPa and 330 kPa over a hold period between 15 s and 20 s using air as the medium. MANUFACTURERS may 267
use a greater applied pressure or longer hold period. 268
Check compliance by applying the tests of ISO 80369-20:—, Annex B, while using the leakage reference 269
CONNECTOR specified in Annex C. 270
6.2.3 Positive pressure liquid leakage 271
Neuraxial SMALL-BORE CONNECTORS evaluated for fluid leakage performance with the positive pressure liquid 272
leakage TEST METHOD shall show no signs of leakage, sufficient to form a falling drop of water, over a hold period 273
of 30 s to 35 s while being subjected to an applied pressure of between 300 kPa and 330 kPa. MANUFACTURERS 274
may use a greater applied pressure or a longer hold period. 275
Check compliance by applying the tests of ISO 80369-20:—, Annex C, while using the leakage reference 276
CONNECTOR specified in Annex C. 277
6.3 Subatmospheric-pressure air leakage 278
Neuraxial SMALL-BORE CONNECTORS evaluated for subatmospheric pressure air leakage. Neuraxial SMALL-BORE 279
CONNECTORS shall not leak by more than 0,005 Pa·m3/s while being subjected to an applied subatmospheric 280
pressure of between 80,0 kPa and 88,0 kPa over a hold period of between 15 s and 20 s. MANUFACTURERS may 281
use a greater applied subatmospheric pressure. 282
Check compliance by applying the tests of ISO 80369-20:—, Annex D, while using the stress cracking reference 283
CONNECTOR specified in Annex C. 284
6.4 Stress cracking 285
Neuraxial SMALL-BORE CONNECTORS evaluated for stress cracking. Neuraxial SMALL-BORE CONNECTORS shall meet 286
the requirements of 6.2.1 after being subjected to stresses of ISO 80369-20:—, Annex E. 287
Check compliance by applying the tests of ISO 80369-20:—, Annex E, while using the stress cracking reference 288
CONNECTOR specified in Annex C. 289
6.5 Resistance to separation from axial load 290
Neuraxial SMALL-BORE CONNECTORS shall be evaluated for separation from axial load. Neuraxial SMALL-BORE 291
CONNECTORS shall not separate from the reference CONNECTOR over a hold period between 10 s and 15 s while 292
being subjected to a disconnection applied axial force between: 293
a) 23 N and 25 N for a SLIP CONNECTOR; and 294
b) 32 N and 35 N for a LOCK CONNECTOR. 295
MANUFACTURERS may use a greater disconnection applied axial force or a longer hold period. 296
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6 © ISO/IEC 2014 – All rights reserved
Check compliance by applying the tests of ISO 80369-20:—, Annex F, while using the separation from axial load 297
reference CONNECTOR specified in Annex C. 298
6.6 Resistance to separation from unscrewing 299
LOCK CONNECTORS shall be evaluated for separation from unscrewing. A LOCK CONNECTOR shall not separate from 300
the reference CONNECTOR for a hold period between 10 s and 15 s while being subjected to an unscrewing torque 301
of between 0,0198 N·m to 0,02 N·m. MANUFACTURERS may use a greater applied unscrewing torque or a longer 302
hold period. 303
Check compliance by applying the tests of ISO 80369-20:—, Annex G, while using the separation from axial load 304
reference CONNECTOR specified in Annex C. 305
6.7 Resistance to overriding 306
Neuraxial SMALL-BORE CONNECTORS shall be evaluated for resistance to overriding. Neuraxial SMALL-BORE 307
CONNECTORS shall not override the threads or lugs of the reference CONNECTOR while being subjected to an 308
applied torque of between 0,15 N·m to 0,17 N·m over a hold period between 5 s and 10 s. MANUFACTURERS may 309
use a greater applied torque or a longer hold period. 310
Check compliance by applying the tests of ISO 80369-20:—, Annex H, while using the separation from axial load 311
reference CONNECTOR specified in Annex C. 312
313
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© ISO/IEC 2014 – All rights reserved 7
Annex A 314
315
(informative) 316
317
Rationale and guidance 318
A.1 General guidance 319
This Annex provides a rationale for some requirements of ISO 80369-6, and is intended for those who are familiar 320
with the subject of ISO 80369-6 but who have not participated in its development. An understanding of the 321
rationale underlying these requirements is considered to be essential for their proper application. Furthermore, as 322
clinical practice and technology change, it is believed that a rationale will facilitate any revision of this part of 323
ISO 80369 necessitated by those developments. 324
A.2 Rationale for particular clauses and subclauses 325
The clauses and subclauses in this Annex have been numbered to correspond to the numbering of the clauses 326
and subclauses of this document to which they refer. The numbering is, therefore, not consecutive. 327
Subclause 1 – Scope 328
In 2000, a Task Group of the European standards organisation CEN proposed a strategy to reduce incidents of 329
accidental misconnection of PATIENT therapy lines by the use of a series of NON-INTERCONNECTABLE 330
CONNECTORS, differentiated by design, for use in different medical applications. The strategy reserves the use of 331
Luer CONNECTORS solely for use in MEDICAL DEVICES used to access the vascular system or for hypodermic 332
syringes so that they can achieve their intended function. [5] The CONNECTORS .of this standard are reserved for 333
neuraxial APPLICATIONS. 334
MANUFACTURERS and RESPONSIBLE ORGANIZATIONS are encouraged to report their experience with the SMALL-BORE 335
CONNECTORS specified in this part of ISO 80369 to the Secretariat of ISO TC 210, so that it can consider this 336
feedback during the revision of the relevant part of this series of International Standards. 337
Annex B 338
Dimension ‘K’ & ‘k’ are defined to ensure an understanding by MANUFACTURERS of the extent of the CONNECTOR. 339
Failure to comply with these minimum dimensions could result in the inability to properly connect to neuraxial 340
CONNECTORS produced by other MANUFACTURERS. The Figure A.1 and Figure A.2 illustrates this concern. 341
All surface finishes of parts of these CONNECTORS which do not form part of the mating surfaces should be 342
constructed so as to avoid the possibility of any another CONNECTOR, which could be present in the clinical 343
environment, from being able to form a fluid-tight CONNECTION to the CONNECTORS specified within this standard. 344
This ensures that attempts made to connect any other CONNECTOR (not complying with this part of ISO 80369) to 345
one specified within this standard results in fluid leakage and the failure to establish a fluid-tight path into the 346
CONNECTORS specified within this standard. 347
Annex B defines a maximum internal diameter of the male CONNECTOR, to prevent inadvertent male-to-male 348
connectivity between the CONNECTORS defined within this standard and any other standardised SMALL-BORE 349
CONNECTORS used in healthcare APPLICATIONS. 350
351
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352
NOTE The cones form a seal properly. 353
Figure A.1 — Extent of the CONNECTOR, compliant with standard (K > 8,6 mm) 354
355
NOTE The cones do not form a seal properly. 356
Figure A.2 — Extent of the CONNECTOR, not compliant with standard (K < 8,6 mm) 357
H.1 – Purpose 358
Several deviations from the physical testing for NON-INTERCONNECTABLE characteristics TEST METHOD of 359
ISO 80369-1:2010, Annex B were developed. These include: 360
a) Axial force up to 70 N is changed to (70 ± 1) N to clarify the requirement. 361
NOTE if no axial load were applied, this would be less than 70 N and would meet the technical requirements but not the 362
intent of the standard. 363
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© ISO/IEC 2014 – All rights reserved 9
b) Rotate up to 270° rather than 90°. CONNECTORS employ dual start threads spaced 180° apart. Rotating only 364
90° allows a false negative since this is less than 180°. 365
c) The axial separation force is changed to either 0,02 N or the weight of the CONNECTOR to allow for gravity 366
testing if desired. 367
d) Physical NON-INTERCONNECTABLE characteristics are defined as a combination of parts mechanically mating 368
but also leaking at a low-flow rate that a USER might not notice. 369
Change to disconnection at 2 g or the weight of the CONNECTOR. 370
The NON-INTERCONNECTABLE characteristics TEST METHOD described in ISO 80369-1, Annex B, poses technical 371
challenges for MANUFACTURERS to perform accurately. According to the original Annex B TEST METHOD, the 372
CONNECTORS are compressed with an axial load of 70 N and a torque of 0,12 N·m for 10 s and then are required 373
disconnect with a force no greater than 0,02 N (2 g). Many MANUFACTURERS and test houses want to use a tensile 374
tester to apply the axial load and the disconnection force with the same instrument. To apply the 70 N axial load, 375
a 100 N load cell is required to handle the 70 N applied load. A typical 100 N load cell has an accuracy of 0,1% 376
which means that a 100 N load cell is only accurate to ± 0,1 N. This is not sufficiently accurate to measure a 377
0,02 N disconnection force. Thus, the same instrument cannot measure both the applied axial load and the 378
disconnection force with the accuracy required to perform the TEST METHOD. 379
Since using one instrument to apply a 70 N load and detect a 0,02 N separation force is not practical, a gravity 380
detection method is permitted after applying the load and torque. The TEST METHOD is modified such that the 381
CONNECTORS are required to disengage with either 0,02 N or the weight of the CONNECTOR. Most neuraxial 382
components weigh more than 2 grams so the acceptance criteria must be modified to accommodate the weight of 383
the part. Table A.1 shows representative part weights of common neuraxial components. 384
Table A.1 Mass of Common Neuraxial Components6 385
Neuraxial component Mass
g
Equivalent force
N
LOR syringe (10 cc barrel only) 4,40 0,044
Spinal needle (25 gauge) and protective sheath but no stylet 1,99 0,02
Epidural tuohy needle (16 gauge) and protective sheath but no stylet 3,99 0,04
Syringe (20 ml barrel only) 6,70 0,067
Filter 0,2 micron flat in line 5,14 0,051
Catheter CONNECTOR 3,40 0,034
386
H.5 – Test procedure, leakage 387
The NON-INTERCONNECTABLE characteristics physical TEST METHOD defined in ISO 80369-1:2010, Annex B, sets 388
optimal and desirable goals, which are practically difficult to implement with all SMALL-BORE CONNECTORS. This 389
TEST METHOD utilizes a very high axial load (70 N). Anaesthesiologists are highly unlikely to apply such a large 390
force to connect two CONNECTORS when undertaking a spinal injection due to the RISK of moving the needle and 391
dislodging the tip from the intrathecal space. However, higher forces are possible when connecting MEDICAL 392
DEVICES distant from the PATIENT such as an administration set to an epidural filter. The 70 N axial load was 393
established based on what a USER could physically apply; not necessarily what a neuraxial USER would likely 394
apply in a clinical setting. [13] 395
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10 © ISO/IEC 2014 – All rights reserved
The usability study reported in G.4 demonstrated that a 70 N axial load is excessive for this APPLICATION. The 396
average force at which USERS recognized a misconnection and stopped trying to connect was 26 N. One user did 397
exceed 70 N (86 N). This data indicates that most clinicians would recognize a misconnection well below the axial 398
load levels set by the original TEST METHOD. 399
During the same usability study, the leak rate of a misconnection was evaluated as to what leak rate the clinicians 400
would recognize that the non-mating parts were leaking. The clinicians all stated that this misconnection would 401
not cause a significant clinical RISK because the high force needed to make the CONNECTION combined with 402
profuse leaking, would provide sufficient clues of a mis-connection and they would stop the procedure. 403
USERS were asked at what leakage rate they would expect to identify a leak and stop delivering medication. The 404
average leakage rate at which clinicians would notice a leak was 6 % and the maximum leakage rate was 25 %. 405
By setting the minimum leak requirement at 75 %, more than 99,9 % of clinicians would recognize a 406
misconnection and stop administering medication. [15] To clarify, clinicians are stating that they would recognize 407
a leak if the leak was 1 % up to 25 % of the total infusate. This is not an indication that fluid passage through the 408
device is acceptable. This study was modelled after misconnection testing conducted by Cook. [7] This study 409
analysed anaesthesiologists reaction to new non-Luer neuraxial MEDICAL DEVICES. Of the various misconnections 410
noted in the report, the clinicians discounted the misconnections that leaked significantly. The clinicians stated 411
that between the high force to connect and profuse leaking, the CONNECTION was not a clinical RISK. 412
A second experiment was conducted to evaluate if a low flow infusion pump with a flow rate of 4 ml/h could pump 413
medication through a misconnection and not be noticed by a clinician. Eight 20 gauge epidural catheters and 414
catheter CONNECTORS were misconnected with a male N2 CONNECTOR, to female L1, as described in 415
ISO 80369-7:—. A low flow infusion pump provided a steady, low flow rate of 4 ml/hr. The misconnected joint did 416
not allow any pressure to be generated upstream of the catheter and no fluid was pumped into the catheter; 417
100 % of low flow fluid leaked from the misconnection. Therefore, even if a misconnection is made and a gross 418
leak is not detected by the clinician, fluid is not erroneously delivered to the PATIENT. 419
ISO/IEC DIS 80369-6
© ISO/IEC 2014 – All rights reserved 11
Annex B 421
422
(normative) 423
424
* SMALL-BORE CONNECTORS for neuraxial APPLICATIONS 425
426
Table B.1 contains the dimensions for this figure. 427
Figure B.1 — Male neuraxial SLIP CONNECTOR (N1) 428
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12 © ISO/IEC 2014 – All rights reserved
Table B.1 — Male neuraxial SLIP CONNECTOR dimensions (N1) 429
Dimensions in mm unless otherwise indicated 430
Male neuraxial SLIP CONNECTOR (N1)
Reference Designation Dimension
Minimum Nominal Maximum
(a) Angle of the taper (5 % taper nominal) (degrees, reference)
(2,58°) (2,86°) (3,15°)
c Recess or protrusion of the tip of the CONNECTOR from the collar a -0.200 0.000 0.400
Ød Outside diameter at the tip of the male taper at 0,500 (basic dimension) from the tip (small end) of the male taper
3,185 3,210 3,235
e Length of the male taper b 8,130 8,380 8,630
Øf Inside diameter at the tip of the male taper — 1,150— 2,300
Øg Outside diameter of the larger end of the male taper at 6,500 (basic dimension) from the tip (small end) of the male taper
3,450 3,510 3,570
Øh Inside collar diameter 6,750 6,925 7,100
k Length of CONNECTOR from tip of the male taper c 8,000 8,300 —
r1 Radius or chamfer at the outside tip of the male taper
0,000 0,100 0,200
r2 Radius or chamfer at the tip of the male outside diameter of minimum tangential circle of the male collar (dimension Øw)
0,000 0,100 0,200
r3 Radius or chamfer at the inside tip of the male lumen
0,000 0,100 0,200
r4 Radius or chamfer at the inside tip of the male collar
0,000 0,100 0,200
Øu Inside diameter of the fluid lumen of the CONNECTOR (optional)
— 1,150 2,300
Øw Diameter of the smallest cylinder of depth k that encompasses the outside surfaces of the external features of the collar d
8,850 10,575 12,300
a The minimum dimension indicated defines the recess of the tip of the CONNECTOR from the collar and the maximum dimension defines the protrusion of the tip of the CONNECTOR from the collar.
b This dimension also defines the internal extent of the CONNECTOR. MEDICAL DEVICE features beyond the CONNECTOR may require evaluation to ISO 80369-1:2010, Annex B, to ensure NON-INTERCONNECTABLE characteristics.
c This dimension also defines the external extent of the CONNECTOR. MEDICAL DEVICE features beyond the CONNECTOR may require evaluation to ISO 80369-1:2010, Annex B, to ensure NON-INTERCONNECTABLE characteristics.
d Either the CONNECTOR or the MEDICAL DEVICE that incorporates this CONNECTOR may achieve this dimension. Alternatively, NON-INTERCONNECTABLE characteristics may be demonstrated using ISO 80369‐1:2010, Annex B.
431
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432
Table B.2 contains the dimensions for this figure. 433
Figure B.2 — Male neuraxial LOCK CONNECTOR (N2) 434
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14 © ISO/IEC 2014 – All rights reserved
Table B.2 — Male neuraxial LOCK CONNECTOR dimensions (N2) 435
Dimensions in mm unless otherwise indicated 436
Male neuraxial LOCK CONNECTOR (N2)
Reference Designation Dimension
Minimum Nominal Maximum
b Angle of the internal thread profile on the nonbearing surface against separation (degrees, reference)
(11,25°) (13,75°) (16,25°)
Øj Minor inside thread diameter (diameter at the thread crest)
5,420 5,520 5,620
(m) Width of the thread profile at the crest (reference) — (0,651) —
n Width of the thread profile at the root 0,890 0,995 1,100
p Pitch of the double‐start, right‐hand thread (reference 5 mm lead)
2,400 2,500 2,600
r5 Radius or chamfer on male thread — 0,090 0,100
s Angle of the internal thread profile on the bearing surface against separation (degrees)
11,25° 13,75° 16,25°
t Distance from the tip of the CONNECTOR to the start at the root of the first complete thread profile of the internal thread
— 1,500 1,800
The design and dimensions of the thread profile (s, b and m) may vary from those designated providing the CONNECTOR meets the performance requirements of Clause 6.
Thread revolution length is not specified, but shall provide clearance for the thread of the female CONNECTOR.
The male neuraxial LOCK CONNECTOR shall include the dimensions and tolerances of the male neuraxial SLIP CONNECTOR as specified in Figure B.1 and Table B.1.
437
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© ISO/IEC 2014 – All rights reserved 15
438
Table B.3 contains the dimensions for this figure. 439
Figure B.3 — Male neuraxial LOCK CONNECTOR with rotatable collar (N2) 440
ISO/IEC DIS 80369-6
16 © ISO/IEC 2014 – All rights reserved
Table B.3 — Male neuraxial LOCK CONNECTOR with rotatable collar dimensions (N2) 441
Dimensions in mm unless otherwise indicated 442
Male neuraxial LOCK CONNECTOR with rotatable collar (N2)
Reference Designation Dimension
Minimum Nominal Maximum
c c Recess of the tip of the CONNECTOR from the collar -0,200 0,000 0,400
e Length of the male taper 8,130 8,380 8,630
k d Length of CONNECTOR from tip of the male taper b 8,000 8,300 —
t d Distance from the tip of the CONNECTOR to the start at the root of the first complete thread profile of the internal thread
— 1,500 1,800
The male neuraxial LOCK CONNECTOR shall include the dimensions and tolerances of the male neuraxial CONNECTOR as specified in Figures B.1 and B.2 and Tables B.1 and B.2.
a This dimension also defines the internal extent of the CONNECTOR. MEDICAL DEVICE features beyond the CONNECTOR may require evaluation Annex H, to ensure NON-INTERCONNECTABLE characteristics.
b This dimension also defines the external extent of the CONNECTOR. MEDICAL DEVICE features beyond the CONNECTOR may require evaluation Annex H, to ensure NON-INTERCONNECTABLE characteristics.
c This dimension is when the rotatable collar is positioned fully away from tip of the CONNECTOR. The minimum dimension indicated defines the recess of the tip of the CONNECTOR from the collar and the maximum dimension defines the protrusion of the tip of the CONNECTOR from the collar.
d This dimension is when the rotatable collar is positioned fully toward the tip of the CONNECTOR.
443
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444
Table B.4 contains the dimensions for this figure. 445
Figure B.4 — Female neuraxial LOCK CONNECTOR (N2) 446
ISO/IEC DIS 80369-6
18 © ISO/IEC 2014 – All rights reserved
Table B.4 — Female neuraxial LOCK CONNECTOR dimensions (N2) 447
Dimensions in mm unless otherwise indicated 448
Female neuraxial LOCK CONNECTOR (N2)
Reference Designation Dimension
Minimum Nominal Maximum
(A) Angle of the taper (5 % taper nominal) (degrees, reference)
— (2,86°) —
B Angle of the internal thread profile on the nonbearing surface against separation (degrees)
11,25° 13,75° 16,25°
ØD Inside diameter at the open end of the female taper at 0,500 (basic dimension) from the opening (large end) of the female taper
3,405 3,430 3,455
E Depth of the female taper a 8,200 8,450 8,700
ØG Inside diameter of the smaller end of the female taper at 6,500 (basic dimension) from the opening (large end) of the female taper
3,070 3,130 3,190
ØH
Major outside thread diameter (diameter at the thread crest) for the extent of the thread feature. This defines the diameter of the smallest cylinder of depth K that encompasses the outside surfaces of the external features of the CONNECTOR.
6,120 6,220 6,320
ØJ Minor outside thread diameter (diameter at the thread root)
5,000 5,185 5,370
K Length of the CONNECTOR b 8,600 8,900 —
(M) Width of the thread profile at the crest (reference) — (0,787) —
N Width of the thread profile at the root at a diameter corresponding to ØJ maximum (5,370)
0,890 0,995 1,100
P Pitch of the double‐start, right‐hand thread (reference 5 mm lead)
2,400 2,500 2,600
R1 Radius or chamfer at the entrance of the female taper
0,000 0,100 0,200
R2 Radius or chamfer on the female thread 0,000 0,090 0,100
S Angle of the internal thread profile on the bearing surface against separation (degrees)
11,25° 13,75° 16,25°
ØU Inside diameter of the fluid lumen of the CONNECTOR (optional)
— 1,500 2,300
The design and dimensions of the thread profile (s, b and m) may vary from those designated providing the CONNECTOR meets the performance requirements of Clause 6.
a This dimension also defines the internal extent of the CONNECTOR. MEDICAL DEVICE features beyond the CONNECTOR may require evaluation to Annex H to ensure NON-INTERCONNECTABLE characteristics.
b This dimension also defines the external extent of the CONNECTOR. MEDICAL DEVICE features beyond the CONNECTOR may require evaluation to Annex H to ensure NON-INTERCONNECTABLE characteristics.
449
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450
Table B.5 contains the dimensions for this figure. 451
Figure B.5 — Female neuraxial LOCK CONNECTOR with lugs (N2) 452
ISO/IEC DIS 80369-6
20 © ISO/IEC 2014 – All rights reserved
Table B.5 — Female neuraxial LOCK CONNECTOR with lugs dimensions (N2) 453
Dimensions in mm unless otherwise indicated 454
Female neuraxial SLIP CONNECTOR with lugs (N2)
Reference Designation Dimension
Minimum Nominal Maximum
(A) Angle of the taper (5 % taper nominal) (degrees, reference)
— (2,86°) —
ØD Inside diameter at the open end of the female taper at 0,500 (basic dimension) from the opening (large end) of the female taper
3,405 3,430 3,455
E Depth of the female taper a 8,200 8,450 8,700
ØG Inside diameter of the smaller end of the female taper at 6,500 (basic dimension) from the opening (large end) of the female taper
3,070 3,130 3,190
ØH
Major outside lug diameter (diameter at the lug crest) for the extent of the lug feature. This defines the diameter of the smallest cylinder of depth K that encompasses the outside surfaces of the external features of the CONNECTOR.
6,120 6,220 6,320
ØJ Minor outside lug diameter (diameter at the lug root)
5,000 5,185 5,370
K Length of the CONNECTOR b 8,600 8,900 —
M Width of the lug profile at the crest 0,400 0,500 0,600
N Width of the lug profile at the root at a diameter corresponding to ØJ maximum (5,370)
0,700 0,900 1,100
R1 Radius or chamfer at the entrance of the female taper
0,000 0,100 0,200
R2 Radius or chamfer on the female lug 0,000 0,090 0,100
ØU Inside diameter of the fluid lumen of the CONNECTOR (optional)
— 1,500 2,300
V Angle of the slope of the lug to be measured from a plane parallel with the tip of the CONNECTOR (degrees)
11,0° 13,0° 15,0°
Y
Chord length at the base of the lug in a plane at a right angle to the axis of the CONNECTOR, to be measured on a chord of a circle, the diameter of which is 5,370
4,100 4,250 4,400
The design and dimensions of the lug profile (M and V) may vary from those designated providing the CONNECTOR meets the performance requirements of Clause 6.
a This dimension also defines the internal extent of the CONNECTOR. MEDICAL DEVICE features beyond the CONNECTOR may require evaluation to Annex H to ensure NON-INTERCONNECTABLE characteristics.
b This dimension also defines the external extent of the CONNECTOR. MEDICAL DEVICE features beyond the CONNECTOR may require evaluation to Annex H to ensure NON-INTERCONNECTABLE characteristics.
455
456
DRAFT INTERNATIONAL STANDARD ISO/IEC DIS 80369-6
© ISO/IEC 2014 – All rights reserved 21
Annex C 457
458
(normative) 459
460
Reference CONNECTORS for testing SMALL-BORE CONNECTORS 461
for neuraxial APPLICATIONS 462
C.1 General requirements for reference CONNECTORS 463
The reference CONNECTORS shall be manufactured from corrosion-resistant RIGID MATERIALS with a surface 464
roughness value, Ra, not exceeding 0,8 μm on critical surfaces. 465
The dimensions of these reference CONNECTORS shall be in accordance with those specified in Figure C.1 and 466
Table C.1 or Table C.2, as appropriate. 467
468
469
470
471
472
473
474
475
476
477
478
479
480
481
482
483
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22 © ISO/IEC 2014 – All rights reserved
C.2 Reference CONNECTORS 484
485
NOTES: 486 1. THREAD IS TWO START 487 2. REFERENCE CONNECTOR IS TO BE USED WITH TEST: 488
FLUID LEAKAGE BY PRESSURE DECAY 489 FALLING DROP POSITIVE PRESSURE LIQUID LEAKAGE 490 SUB ATMOSPHERIC PRESSURE AIR LEAKAGE 491 STRESS CRACKING 492 RESISTANCE TO SEPARATION FROM UNSCREWING 493
3. SEALING CONE SURFACE FINISH TO BE 0.4µm Ra OR FINER (ROUGHNESS AVERAGE) PER VISUAL COMPARISON TO 494 SURFACE FINISH STANDARDS, OR EQUIVALENT GAUGING METHOD. 495
4. THREAD FLANK SURFACE FINISH TO BE 0.8µm Ra OR FINER (ROUGHNESS AVERAGE) PER VISUAL COMPARISON TO 496 SURFACE FINISH STANDARDS, OR EQUIVALENT GAUGING METHOD 497
5. COMPLIANCE OF ALL LISTED DIMENSIONS ARE REQUIRED FOR INITIAL CALIBRATION 498 6. MINIMUM COMPLIANCE VERIFICATIONS FOR SUBSEQUENT CALIBRATION 499 7. (REFERENCE: THREADS TO COMPLETE ONE FULL REVOLUTION) 500 8. RELIEF CUT 0.200 MAXIMUM DEPTH 501 9. MASTER GAGES CAN BE USED FOR CALIBRATION VERIFICATIONS (TAPER GAGE EXAMPLE SHOWN BELOW) 502
1. APPLY A THIN FILM OF BLUEING TO GAUGING SURFACE 503 2. INSERT GAGE INTO TESTING CONNECTOR 504 3. APPLY 2N +/-0.25N FORCE TO MASTER GAGE 505 4. APPLY 90 DEGREE +/-45 DEGREE TURN TO MASTER GAGE 506 5. BLUEING MASTER GAGE METHODS ARE TO ACHIEVE 75% MINIMUM BLUEING CONTACT OF THE TESTED 507
CONNECTOR TO SHOW CONNECTOR ACCEPTABILITY 508
509
Figure C.1 — Female reference LOCK CONNECTOR for testing male neuraxial CONNECTORS for leakage, 510
separation from unscrewing, stress cracking and NON-INTERCONNECTABLE characteristics 511
512
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© ISO/IEC 2014 – All rights reserved 23
513
NOTES: 514 1. REFERENCE CONNECTOR IS TO BE USED WITH TEST: 515
FLUID LEAKAGE BY PRESSURE DECAY 516 FALLING DROP POSITIVE PRESSURE LIQUID LEAKAGE 517 SUB ATMOSPHERIC PRESSURE AIR LEAKAGE 518 STRESS CRACKING 519 RESISTANCE TO SEPARATION FROM AXIAL LOAD 520
2. SEALING CONE SURFACE FINISH TO BE 0.4µm Ra OR FINER (ROUGHNESS AVERAGE) PER VISUAL COMPARISON TO 521 SURFACE FINISH STANDARDS, OR EQUIVALENT GAUGING METHOD. 522
3. COMPLIANCE OF ALL LISTED DIMENSIONS ARE REQUIRED FOR INITIAL CALIBRATION 523 4. MINIMUM COMPLIANCE VERIFICATIONS FOR SUBSEQUENT CALIBRATION 524 5. GO/NO-GO GAGES CAN BE USED FOR CALIBRATION VERIFICATIONS, WHERE APPLICABLE 525 6. MASTER GAGES CAN BE USED FOR CALIBRATION VERIFICATIONS (TAPER GAGE EXAMPLE SHOWN BELOW) 526
1. APPLY A THIN FILM OF BLUEING TO GAUGING SURFACE 527 2. INSERT GAGE INTO TESTING CONNECTOR 528 3. APPLY 2N +/-0.25N FORCE TO MASTER GAGE 529 4. APPLY 90 DEGREE +/-45 DEGREE TURN TO MASTER GAGE 530 5. BLUEING MASTER GAGE METHODS ARE TO ACHIEVE 75% MINIMUM BLUEING CONTACT OF THE TESTED 531
CONNECTOR TO SHOW CONNECTOR ACCEPTABILITY 532
533
Figure C.2 — Male reference SLIP CONNECTOR for testing female neuraxial CONNECTORS for leakage, 534
separation from unscrewing, stress cracking and NON-INTERCONNECTABLE characteristics 535
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24 © ISO/IEC 2014 – All rights reserved
536
NOTES: 537 1. REFERENCE CONNECTOR IS TO BE USED WITH TEST: 538
RESISTANCE TO SEPARATION FROM AXIAL LOAD 539 RESISTANCE TO OVER-RIDING 540
2. SEALING CONE SURFACE FINISH TO BE 0.4µm Ra OR FINER (ROUGHNESS AVERAGE) PER VISUAL COMPARISON TO 541 SURFACE FINISH STANDARDS, OR EQUIVALENT GAUGING METHOD. 542
3. LUG FLANK SURFACE FINISH TO BE 0.8µm Ra OR FINER (ROUGHNESS AVERAGE) PER VISUAL COMPARISON TO SURFACE 543 FINISH STANDARDS, OR EQUIVALENT GAUGING METHOD 544
4. COMPLIANCE OF ALL LISTED DIMENSIONS ARE REQUIRED FOR INITIAL CALIBRATION 545 5. MINIMUM COMPLIANCE VERIFICATIONS FOR SUBSEQUENT CALIBRATION 546 6. MASTER GAGES CAN BE USED FOR CALIBRATION VERIFICATIONS (TAPER GAGE EXAMPLE SHOWN BELOW) 547
1. APPLY A THIN FILM OF BLUEING TO GAUGING SURFACE 548 2. INSERT GAGE INTO TESTING CONNECTOR 549 3. APPLY 2N +/-0.25N FORCE TO MASTER GAGE 550 4. APPLY 90 DEGREE +/-45 DEGREE TURN TO MASTER GAGE 551 5. BLUEING MASTER GAGE METHODS ARE TO ACHIEVE 75% MINIMUM BLUEING CONTACT OF THE TESTED 552
CONNECTOR TO SHOW CONNECTOR ACCEPTABILITY 553
554
Figure C.3 — Female reference CONNECTOR for testing male neuraxial CONNECTORS for separation from 555
axial load and resistance to overriding 556
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© ISO/IEC 2014 – All rights reserved 25
557
NOTES: 558 1. THREAD IS TWO START 559 2. REFERENCE CONNECTOR IS TO BE USED WITH TEST: 560
FLUID LEAKAGE BY PRESSURE DECAY 561 FALLING DROP POSITIVE PRESSURE LIQUID LEAKAGE 562 SUB ATMOSPHERIC PRESSURE AIR LEAKAGE 563 STRESS CRACKING 564 RESISTANCE TO SEPARATION FROM REVERSAL TORQUE 565
3. SEALING CONE SURFACE FINISH TO BE 0.4µm Ra OR FINER (ROUGHNESS AVERAGE) PER VISUAL COMPARISON TO 566 SURFACE FINISH STANDARDS, OR EQUIVALENT GAUGING METHOD. 567
4. THREAD FLANK SURFACE FINISH TO BE 0.8µm Ra OR FINER (ROUGHNESS AVERAGE) PER VISUAL COMPARISON TO 568 SURFACE FINISH STANDARDS, OR EQUIVALENT GAUGING METHOD 569
5. COMPLIANCE OF ALL LISTED DIMENSIONS ARE REQUIRED FOR INITIAL CALIBRATION 570 6. MINIMUM COMPLIANCE VERIFICATIONS FOR SUBSEQUENT CALIBRATION 571 7. MEASURE TO FLAT FACE ON THREAD AT JUNCTURE OF THREAD MAJOR DIAMETER AND THREAD 572 8. CIRCUMFERENCIAL WITNESS LINE ACCEPTABLE FROM MACHINING MUST MAINTAIN DIMENSIONAL REQUIREMENTS 573 9. GO/NO-GO GAGES CAN BE USED FOR CALIBRATION VERIFICATIONS, WHERE APPLICABLE 574 10. MASTER GAGES CAN BE USED FOR CALIBRATION VERIFICATIONS (TAPER GAGE EXAMPLE SHOWN BELOW) 575
1. APPLY A THIN FILM OF BLUEING TO GAUGING SURFACE 576 2. INSERT GAGE INTO TESTING CONNECTOR 577 3. APPLY 2N +/-0.25N FORCE TO MASTER GAGE 578 4. APPLY 90 DEGREE +/-45 DEGREE TURN TO MASTER GAGE 579 5. BLUEING MASTER GAGE METHODS ARE TO ACHIEVE 75% MINIMUM BLUEING CONTACT OF THE TESTED 580
CONNECTOR TO SHOW CONNECTOR ACCEPTABILITY 581
582
Figure C.4 — Male reference LOCK CONNECTOR for testing female neuraxial CONNECTORS for leakage, 583
separation from unscrewing, stress cracking and NON-INTERCONNECTABLE characteristics 584
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26 © ISO/IEC 2014 – All rights reserved
585
NOTES: 586 1. THREAD IS TWO START 587 2. REFERENCE CONNECTOR IS TO BE USED WITH TEST 588
RESISTANCE TO SEPARATION FROM AXIAL LOAD 589 RESISTANCE TO OVER-RIDING 590
3. SEALING CONE SURFACE FINISH TO BE 0.4µm Ra OR FINER (ROUGHNESS AVERAGE) PER VISUAL COMPARISON TO 591 SURFACE FINISH STANDARDS, OR EQUIVALENT GAUGING METHOD. 592
4. THREAD FLANK SURFACE FINISH TO BE 0.8µm Ra OR FINER (ROUGHNESS AVERAGE) PER VISUAL COMPARISON TO 593 SURFACE FINISH STANDARDS, OR EQUIVALENT GAUGING METHOD 594
5. COMPLIANCE OF ALL LISTED DIMENSIONS ARE REQUIRED FOR INITIAL CALIBRATION 595 6. MINIMUM COMPLIANCE VERIFICATIONS FOR SUBSEQUENT CALIBRATION 596 7. MEASURE TO FLAT FACE ON THREAD AT JUNCTURE OF THREAD MAJOR DIAMETER AND THREAD 597 8. CIRCUMFERENCIAL WITNESS LINE ACCEPTABLE FROM MACHINING MUST MAINTAIN DIMENSIONAL REQUIREMENTS 598 9. GO/NO-GO GAGES CAN BE USED FOR CALIBRATION VERIFICATIONS, WHERE APPLICABLE 599 10. MASTER GAGES CAN BE USED FOR CALIBRATION VERIFICATIONS (TAPER GAGE EXAMPLE SHOWN BELOW) 600
1. APPLY A THIN FILM OF BLUEING TO GAUGING SURFACE 601 2. INSERT GAGE INTO TESTING CONNECTOR 602 3. APPLY 2N +/-0.25N FORCE TO MASTER GAGE 603 4. APPLY 90 DEGREE +/-45 DEGREE TURN TO MASTER GAGE 604 5. BLUEING MASTER GAGE METHODS ARE TO ACHIEVE 75% MINIMUM BLUEING CONTACT OF THE TESTED 605
CONNECTOR TO SHOW CONNECTOR ACCEPTABILITY 606
607
Figure C.5 — Male reference CONNECTOR for testing female neuraxial LOCK CONNECTORS from axial load and 608
resistance to overriding 609
610
611
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Annex D 612
613
(informative) 614
615
Assessment of MEDICAL DEVICES and their attributes 616
with CONNECTIONS within this APPLICATION 617
Table D1 contains examples of MEDICAL DEVICES and ACCESSORIES with neuraxial APPLICATIONS. The table 618
contains an assessment by the working group of the important attributes of MEDICAL DEVICES and ACCESSORIES as 619
they relate to the intended CONNECTION. Each CONNECTION is assessed to the following groups of subgroups: 620
a) Spinal needle CONNECTIONS 621
b) Epidural needle CONNECTIONS 622
c) Regional block needle CONNECTIONS including stimulating needles 623
d) Neuraxial catheter CONNECTORS 624
e) Bacterial filter CONNECTORS 625
f) Infusion line CONNECTORS 626
g) Neuraxial ACCESSORIES such as stopcocks, manometers, drug draw up devices, extension set 627
h) Wound infiltration devices with neuraxial CONNECTORS 628
i) Neuraxial syringe CONNECTORS including loss of resistance (LOR) 629
j) Intrathecal catheters 630
631
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28 © ISO/IEC 2014 – All rights reserved
Table D.1 — Examples of MEDICAL DEVICES with CONNECTIONS 632
within this APPLICATION and their attributes 633
Part/component to which the CONNECTOR is applied In
dex
Flow administration
Type of fluid
Type of CONNECTION
Functionality
Flo
wra
te r
ang
e
ml/m
in
Bo
lus
Air
Liq
uid
CO
NN
EC
TIO
N
Dis
- CO
NN
EC
TIO
N
Lo
ckin
g n
eed
ed
Sli
p n
ee
de
d
Flo
wra
te c
on
tro
l n
eed
ed
Spinal needle (bolus) 1 0 to
3 600 yes yes yes yes yes yes no yes
Epidural/regional block needle (bolus)
2 0 to
3 600 yes yes yes yes yes yes no Yes
Catheter CONNECTOR (bolus) 3 0 to
1 500 yes no yes yes yes yes no yes
Catheter CONNECTOR (infusion)
4 0 to
1 500 yes no yes yes yes yes no yes
Filter (infusion) 5 0 to 600
yes no yes yes yes yes no yes
Filter (bolus) 6 0 to 600
yes no yes yes yes yes no yes
Infusion line 7 0 to 600
yes no yes yes yes yes no yes
Wound infiltration 8 0 to
3 600 yes no yes yes yes yes no yes
Syringe standard 9 0 to
3 600 yes yes yes yes yes yes yes yes
Syringe, loss of resistance (LOR)
10 0 to
3 600 no yes yes yes yes yes yes yes
634
635
ISO/IEC DIS 80369-6
© ISO/IEC 2014 – All rights reserved 29
Annex E 636
637
(informative) 638
639
Summary of the usability requirements 640
for SMALL-BORE CONNECTORS for neuraxial APPLICATIONS 641
E.1 USER PROFILE 642
The USER PROFILE is a summary of the mental, physical and demographic traits of an intended USER population as 643
well as any special characteristics that can have a bearing on design decisions such as occupational skills and 644
job requirements. 645
USERS of SMALL-BORE CONNECTORS for neuraxial APPLICATIONS are comprised of clinical persons using (i.e. 646
operating or handling) the MEDICAL DEVICE, including but not limited to cleaners, maintainers and installers. USERS 647
are expected to perform an intended action in an intended use of a MEDICAL DEVICE, ACCESSORY, PROCESS or 648
service in accordance with the specifications, instructions and information provided by the MANUFACTURER. 649
USERS include: 650
a) Clinical users as: 651
Physicians and nurses (CRNA’s) who specialize in anaesthesiology, neuro-radiology, oncology, 652
interventional radiology, paediatrics, surgery or a physician assistant 653
Nurses, at all levels; 654
b) Non-clinical users such as cleaners, maintainers and installers; and 655
c) Pharmacy or drug delivery USERS responsible for mixing of drugs, filling syringes and reservoirs, storage and 656
dispensing of drugs. 657
The USER PROFILE is summarized in Table E.1 658
Table E.1 — USER PROFILE 659
Clinical USERS Non-clinical USERS Pharmacy/drug delivery USERS
USER skills: Extensive clinical training
Limited clinical training
Pharmacology
PATIENT contact: Direct PATIENT contact Direct PATIENT contact No PATIENT contact
660
E.2 Use scenarios 661
Use scenarios for SMALL-BORE CONNECTORS for neuraxial APPLICATIONS can differ by USER group and are 662
comprised of the multitude of sub-APPLICATIONS of the CONNECTORS within different sub-specialties. 663
ISO/IEC DIS 80369-6
30 © ISO/IEC 2014 – All rights reserved
A summary of use scenarios by USER group is summarized in Table E.2. 664
Table E.2 — Use scenarios 665
Sub-specialty use scenario: Clinical USERS Non-clinical USERS Pharmacy USERS
Spinal diagnostics such as CSF pressure using a manometer column
X
Spinal anaesthetic delivery into the intrathecal space
X X
Intrathecal chemotherapy injection X X
Lumbar epidural bolus injection of anaesthetic agent
X X
Lumbar epidural injection of continuous anaesthetic agent via infusion pump
X X
Peripheral nerve block needle placement and bolus injection of anaesthetic agent
X X
Peripheral nerve block needle placement and continuous injection of anaesthetic agent
X X
Home care PATIENT controlled activation doses from infusion pump
X X
Hospital based PATIENT controlled activation doses from infusion pump
X X X
666
E.3 Use environments 667
E.3.1 Facilities 668
Hospitals, surgery suites, PATIENT rooms, home, labour and delivery, intensive care units doctors’ offices, pain 669
clinics, pharmacy, field hospitals, transport systems, infusion clinics, assisted care, emergency medical services 670
E.3.2 Use temperatures 671
The following temperature environments are expected for neuraxial CONNECTORS: 672
a) Ambient temperature, 0˚C to + 40 ˚C 673
b) Body temperature to 42 ˚C; 674
E.4 Other attributes 675
The following usability attributes are expected for neuraxial CONNECTORS: 676
a) Usability under stress (ignoring labels, attempting force-fit, emergency C-section); 677
b) Limited dexterity: Gloved hands that might or might not be wet. 678
c) Proximity of other CONNECTOR-bearing equipment (e.g. intravenous infusion lines, gas measurement, etc.) 679
ISO/IEC DIS 80369-6
© ISO/IEC 2014 – All rights reserved 31
d) Duration, use-life: 680
Maximum length of epidural infusion ≤ 29 d (includes catheter, catheter CONNECTOR and infusion line) 681
Filters, ≤ 96 h 682
Spinal or epidural needs ≤ 15 min 683
Draw up MEDICAL DEVICES such as filter needles, filter straws etc.; ≤ 15 min 684
Loss of resistance syringes; ≤ 15 min 685
Syringes for short term use; ≤ 15 min 686
Syringes and caps for drug storage ≤ 14 d 687
E.5 Generic USER needs 688
The following USER needs are expected for neuraxial CONNECTORS: 689
a) Minimal pan-healthcare USER training on the use of CONNECTORS; 690
b) Easy to manipulate without the use of tools 691
c) Ease of assembly/disassembly with fingertip control, especially in wet environment or with the use of gloves 692
d) Does not misconnect to other SMALL-BORE CONNECTORS not intended for the same purpose in the environment 693
of use 694
e) Does not leak under NORMAL USE; 695
f) Security/integrity of CONNECTION—cannot unintentionally self-disconnect; 696
g) Low dead space; 697
h) Ease of fluid passage 698
Maximum flowrate 3 600 ml/h 699
Pressure in infusion line at maximum flowrate must not exceed alarm limit on infusion pumps 700
i) Viscosity of solution 701
aqueous 702
chemotherapy 703
Anaesthetics (Bupivacaine, lidocaine, ropivacaine, 2-chloroprocaine, levobupivacaine) 704
Analgesics (Sufentanil) 705
Narcotics (morphine) 706
j) Ability to accommodate catheters through bore of neuraxial CONNECTOR 707
Catheters as large as 16 gauge 708
ISO/IEC DIS 80369-6
32 © ISO/IEC 2014 – All rights reserved
Ability to accommodate stylets (epidural / spinal) and/or guidewires 709
k) Aseptic handling – ability to align and make CONNECTIONS without slipping and inadvertently creating touch 710
contaminations 711
712
ISO/IEC DIS 80369-6
© ISO/IEC 2014 – All rights reserved 33
Annex F 713
714
(informative) 715
716
Summary of SMALL-BORE CONNECTOR criteria and requirements for neuraxial 717
APPLICATIONS 718
Table F.1 is a summary of the design criteria and requirements for the SMALL-BORE CONNECTOR for neuraxial 719
APPLICATIONS. 720
Table F.1 — Neuraxial CONNECTOR - specific criteria and requirements (1 of 2) 721
Criteria Requirements Remarks
1 Fluid type a) liquid b) gas c) both
c)
2 Operating pressure range maximum pressure minimum pressure sub-atmospheric? (Yes/No)
330 kPa N/A Yes: 40 kPa
3 RATED pressure range minimum maximum
N/A
4 Is there a need for a leak test? a) no b) yes Reference for test method
b) Yes
5 RATED flowrate range minimum maximum
N/A
10 ml/min
6 Internal tubing diameter range (through bore) minimum maximum
2,3 mm
7 RATED temperature range minimum maximum
0º C 40º C
8
Minimum range of CONNECTOR mating diameters minimum maximum
– Incompatible with Luer and/ or other new SMALL-BORE MEDICAL CONNECTORS
9
General layout a) Parallel-sided, O-ring seal b) Parallel-sided, other seal c) Conical d) Other (specify)
c) Conical, with a male tip smaller diameter than a Luer
10 Method of keying a) Collar b) Plug c) Other (specify)
N/A
11
Quick release? a) No b) Yes i) single-handed operation ii) double-handed operation
a)
12 Positive locking/unlocking feature? a) No b) Yes
a) and b)
13 Need for visual indication of a) No locking status? b) Yes
a)
14 Need for indication of evidence a) No of tampering? b) Yes
a) Depends on specific MEDICAL DEVICE
15 Need for a syringe in the a) No APPLICATION? b) Yes
b)
16 Need for an absence of sharp a) No edges? b) Yes
b)
ISO/IEC DIS 80369-6
34 © ISO/IEC 2014 – All rights reserved
Table D.1 — (2 of 2) 722
Criteria Requirements Remarks
17 Minimum pull-apart force in normal use, when locked force Reference for test method
35 N Same as Luer
18
Constructional materials a) RIGID MATERIAL (excluding seals) i) metal ii) plastic b) SEMI-RIGID MATERIAL
a) i) ii) b)
19 Need for use of SEMI-RIGID MATERIAL? a) No b) Yes, mating part of CONNECTOR
(apart from seal)
Yes
20
MRI compatibility? a) No, with labelling b) No, without labelling c) Yes, with labelling d) Yes, without labelling
d)
21 Stress-cracking resistance? a) No b) Yes Specify limits
b)
22 Externally, how is CONNECTOR to be distinguishable from Luer? (describe)
23 Proposal for colour-coding? a) No b) Yes Reference standard
a)
24 Labelling/Symbols/Marking? a) No (e.g. not for IV) b) Yes
a)
25 Other method for indicating a) No intended use? b) Yes Indicate method
a)
26 Biocompatibility needed? a) No b) Yes i) indicate tissue types
b) skin and spinal fluid contact
27
Reuse variants a) Multiple PATIENT use b) Single PATIENT use c) Single use d) Non-reusable (indicate method of auto-disabling)
c)
28
Decontamination needed? a) No, single use only b) Yes, cleaning and disinfection indicate method c) Yes, cleaning and sterilization indicate method
a)
29 How is ISO 80369-2 incompatibility a) Dimensional achieved? b) Other Indicate method
b)
30 How is ISO 80369-3 incompatibility a) Dimensional achieved? b) Other Indicate method
a)
31 How is ISO 80369-4 incompatibility a) Dimensional achieved? b) Other Indicate method
not yet defined
32 How is ISO 80369-5 incompatibility a) Dimensional achieved? b) Other Indicate method
a)
33 How is ISO 80369-6 incompatibility a) Dimensional achieved? b) Other Indicate method
This is the neuraxial CONNECTOR
34 How is ISO 80369-7 incompatibility a) Dimensional achieved? b) Other Indicate method
b) Combined CAD analysis and physical testing (Annex H)
723
ISO/IEC DIS 80369-6
© ISO/IEC 2014 – All rights reserved 35
Annex G 724
725
(informative) 726
727
Summary of assessment of the design 728
of the SMALL BORE CONNECTORS for neuraxial APPLICATIONS 729
G.1 General 730
There are no known patents related to the CONNECTOR designs specified in this standard. The CONNECTORS 731
depicted in Annex B use a 6 % taper seal, with mating surface dimensions smaller than the traditional Luer 732
CONNECTOR This design also incorporates other features to prevent these CONNECTORS from either forming a fluid 733
tight seal or being misconnected with SMALL-BORE CONNECTORS of the ISO 80369 series. 734
G.2 Summary of the engineering analysis of the design 735
A three dimensional computer assisted (CAD) engineering analysis has been completed using 3D solid model 736
constructs of all tolerances and material conditions (least, nominal and maximum) for all SMALL-BORE CONNECTORS 737
represented by this series of International Standards. The SMALL-BORE CONNECTORS specified in Annex B have 738
been evaluated by engineering analysis with a threshold interference of 0,4 mm with the other specified 739
CONNECTORS of this series. Five possible misconnections were identified. All other CONNECTIONS have 740
interferences exceeding 0,4 mm. The five possible misconnections are shown in Table G.1 741
Misconnection number three poses no clinical RISK of wrong route administration of fluid since the misconnection 742
results in fluid pumped into a sphygmomanometer cuff. The other potential misconnections were evaluated with 743
physical testing. NON-INTERCONNECTABLE characteristics testing was conducted according to ISO 80369-1:2010, 744
Annex B (test CONNECTORS need to disconnect from a stainless steel reference CONNECTOR after 70 N axial 745
applied compressive load with 0.12 N·m torque). An injection mould was made to make test N2 CONNECTORS to 746
least material conditions (LMC) or nominal dimensions if LMC N2 CONNECTORS were not possible. (N2 747
CONNECTORS at LMC conditions were moulded from polycarbonate (Makralon RX1805 and two grades of 748
polypropylene (Total 3620WZ with flexural modulus 1665 MPa and Total Polypropylene 7238 with tensile 749
modulus of 965 MPa). N2 CONNECTORS at nominal dimensions were moulded from acrylic (Cyrolite G20). N2 750
CONNECTORS were measured and met dimensional specifications specified Annex B except for some radii, which 751
were out of specification and one exception on the threads. The Total PP 7238 threads were slightly undersized 752
(dimension “n” measured 0,83 mm vs. specified range of 0,890 mm to 1.1 mm). Thus, these samples were worst 753
case since they were smaller than the tolerance limit and were made with the most flexible material. Radii not 754
meeting specification are acceptable for evaluating NON-INTERCONNECTABLE characteristics. Radii are limited to 755
prevent misconnection so having radii that are larger challenges the worst case of the design. Stainless steel 756
reference CONNECTORS were machined to nominal dimensions as specified by ISO 80369-1, Annex B. 757
The first two misconnections passed mechanical NON-INTERCONNECTABLE characteristics testing according to 758
Annex H. The third misconnection was not tested since the RISK ANALYSIS indicates virtually no RISK to PATIENTS 759
except possible delay of therapy if fluid is pumped into a sphygmomanometer cuff. The fourth and fifth 760
misconnections interconnect when subjected to the physical mechanical test from Annex H. However, a fluid tight 761
seal is not made following the physical mechanical test. Both misconnections leaked profusely (99.8% and 87.6%, 762
which exceeds minimum required leak rate of 75%). 763
NOTE Annex H rationale contains addition information about the leak test. 764
Clinicians have confirmed that the RISK is acceptable for misconnections where the CONNECTION requires an 765
abnormally high force and the CONNECTION leaks profusely (> 75 % of injectate leaks from the misconnection). 766
The CONNECTION forces for the two misconnections were high. 767
ISO/IEC DIS 80369-6
36 © ISO/IEC 2014 – All rights reserved
Table G.1 — Identified possible misconnections 768
Misconnection number
1 2 3 4 5
Visual representation
Neuraxial CONNECTOR
and condition
N2 male LMC
N2 male LMC
N2 male LMC
N2 male LMC
N2 female LMC
Reference CONNECTOR
and condition
L2 male of ISO 80369-7
(nominal)
E1 male of ISO 80369-3
(nominal)
S1 male of ISO 80369-5
(nominal)
L1 female of ISO 80369-7
(nominal)
E1 female of ISO 80369-3
(nominal)
Failure mode
Medication from Luer to N2 syringe,
then transferred to
PATIENT
Medication intended to
be administered
to the neuraxial space is
administered enterally
Anaesthetic pumped into
pressure cuff, no PATIENT
HARM
Anaesthetic pumped into vascular port
Enteral feeding substances
administered to neuraxial space
Material used
Acrylic (nom), Total PP 3620WZ (LMC)
Polycarbonate (LMC)
Not tested, acceptable clinical RISK
Total PP 7238 (950 MPa.)
LMC Thread
Total PP 7238 (950 MPa)
LMC Thread
Sample Size 40 22 Not tested 30 30
Do CONNECTORS misconnect? (PASS = no CONNECTION)
40 of 40 PASS 22 of 22 PASS
Not tested 14 of 30 PASS 0 of 30 PASS
Gross leak > 75%? N/A N/A Not tested 99,8 % ± 0,46%a 87,6% ± 2,2%a
LMC = least material condition a >99 % confidence of 99 % reliability exceeding 75 % minimum
769
A RISK ANALYSIS was conducted on the total fluid that could be delivered via this CONNECTION. Misconnection five 770
could conceivably administer 13 % of its dose to a PATIENT. The team analysed the likelihood of this event 771
actually happening. 772
G.4 describes a formative usability study which was conducted in April 2014. Clinicians used syringes with 773
embedded force gauges to measure the forces at which they would stop trying to force a misconnection. 774
Figure G.1 shows a distribution of forces at which USERS would recognize a misconnection and stop. 96% of 775
clinicians would not exceed 50 N force before stopping. The misconnection force testing of N.1 female 776
CONNECTOR to E1 female reference CONNECTOR, as specified in ISO 80369-3:—, (Figure G.1, misconnection 5) is 777
shown in Figure G.2. These CONNECTORS required an average force of 55,7 N to insert into the reference 778
CONNECTOR. 99,8 % of CONNECTION forces exceed 50 N. The overlap of these two populations is the percentage 779
of USERS who would exceed the minimum force required to make a misconnection. From Figure G.1, 4 % of 780
ISO/IEC DIS 80369-6
© ISO/IEC 2014 – All rights reserved 37
USERS would exceed 50 N force before they recognize a misconnection and stopped administering medication. 781
Most would stop at a force well below 50 N. Figure G.2 shows that 0.8 % of CONNECTIONS require a force less 782
than 50 N to connect. The overlap of the two populations is 4 % x 0,8 % = 0,03%. In other words, 99,97 % of 783
USERS would stop trying to make the misconnection before achieving a force sufficient to make a misconnection. 784
At this point, the USER would experience a misconnection from which 87 % of the infusate would leak. 785
6050403020100
50 X 21.4838N 28
PPM > USL 38329.35
786
Figure G.1 — Force at which USERS would stop forcing a misconnection 787
788
605856545250
50
X 55.6767N 30StDev 2.39506
PPM < LSL 8890.39
789
Figure G.2 — Force required to misconnect female N2 to female E1 790
791
96 % 4 %
99,2 % > 50 N
0,8 % < 50 N
ISO/IEC DIS 80369-6
38 © ISO/IEC 2014 – All rights reserved
Clinicians in the formative usability study evaluated a grossly leaking CONNECTION. All the USERS in the study 792
stated they would stop administering medication if the leak was greater than 25 % of the total infusate. Most 793
stated they would stop administering medication if even a single drop leaked from the suspected misconnection 794
because the high force to misconnect would make them highly vigilant of a potential misconnection. Figure G.3 795
illustrates the leak rate at which a USER would recognize a leaking CONNECTION and stop delivering medication. 796
Less than one USER per million would be predicted to continue delivery of medication when the leak rate exceed 797
75 %. The likelihood of a USER exerting sufficient force to make a misconnection and continue to deliver 798
medication at a leak rate of 75 % is 0,03% x 0,00006 % = 0,2 wrong route delivery per billion procedures. This 799
RISK is judged to be acceptable by the combination of high connection forces and obvious leaking of the 800
misconnection. 801
7260483624120
USLUSL 75X 6N 27
PPM > USL 0.62
802
Key 803
USL = Upper specification limit 804
LSL = Lower specification limit 805
ẋ = mean 806
N = Sample size 807
PPM = Parts per million expected over USL or less than LSL 808
Figure G.3 — Leakage from a misconnection when a USER would stop 809
810
G.3 Summary of the design VERIFICATION 811
This CONNECTOR design is similar to currently marketed configurations that have been developed in the UK over 812
the last decade. The CONNECTOR design was developed based upon this work and modified to create a design 813
that was NON-INTERCONNECTABLE with the other specified CONNECTORS of this series. CONNECTORS were moulded 814
from two resins, polypropylene (elastic modulus = 960 MPa), and acrylic (elastic modulus = 2,300 MPa) which 815
span the range of available for common materials used whose modulus of elasticity meet the requirements of 4.2. 816
ISO/IEC DIS 80369-6
© ISO/IEC 2014 – All rights reserved 39
By testing high and low modulus of elasticity parts, the testing provides greater confidence that the full range of 817
materials, which can be to create these CONNECTORS, yield acceptable performance. 818
The CONNECTORS were tested against the performance requirements of Clause 6 in a laboratory setting. Tests 819
were performed according the methods contained in ISO 80369-20 and all tests passed demonstrating that these 820
CONNECTORS are suitable for enteral applications. This evaluation included attribute tests for liquid leakage, 821
subatmospheric-pressure air leakage and stress cracking. This evaluation included variable tests for resistance to 822
separation from axial load, resistance to separation from unscrewing and resistance to overriding. 823
Final results to be communicated by ISO/TC 210/JWG4, Small-bore connectors, subsequent to the DIS vote. An 824
“N” document will circulate prior to the completion of the DIS balloting with results from the design verification. 825
826
G.4 Summary of the design validation 827
A formative usability study was conducted in April 2014. The protocol was approved prior to the testing. Twenty 828
anaesthesiologists, six nurses and two CRNA’s were recruited from the Minneapolis, USA area. Participants were 829
asked to connect six different pairs of MEDICAL DEVICES. Some of the pairs would connect and some were 830
purposeful misconnections. A loss of resistance syringe with N2 male CONNECTOR was tested to a flat filter with a 831
N2 female CONNECTOR and also to L1 female CONNECTOR, as specified by ISO 80369-7:2014, on a similar filter. 832
Two simulated 10 ml syringes incorporated a force gauge so that the forces applied during misconnections could 833
be measured. One simulated syringe had a L1 female, as specified by ISO 80369-7:2014, machined to make a 834
misconnection with a male N2 CONNECTOR. A second simulated syringe had a machined E1 female CONNECTOR 835
that misconnected with a N2 female CONNECTOR on a filter. Participants were asked to connect neuraxial 836
CONNECTORS to the simulated syringes (purposeful misconnection) and the CONNECTION forces were recorded. 837
The average force at which USERS recognized a misconnection and stopped trying to connect was 26 N. One 838
USER did exceed 70 N (86 N). This data indicates that most physicians would recognize a misconnection well 839
below the axial load levels required by this standard. None of the 28 clinicians had problems connecting 840
neuraxial CONNECTORS to other neuraxial CONNECTORS. 841
During the same study, participants were asked to connect a 10 ml N2 syringe to a L1 female, as specified by 842
ISO 80369-7:2014, attached to a spinal needle. The 10 ml syringe was filled with water. All participants stopped 843
and commented that the CONNECTION did not seem valid. The CONNECTION was forced by either the moderator or 844
the participant and then the participant was asked to deliver medication through the 22 gauge spinal needle. The 845
misconnection leaked profusely (98 % of administrate leaked from the misconnected joint). Twenty-eight of 846
twenty-eight clinicians concluded that this misconnection was not a clinical RISK; they would have sufficient clues 847
with the difficulty to force a misconnection combined with gross leaking of the CONNECTION. 848
A summative usability study was conducted in four centres in the UK: Bridgend, Bath, Bristol, Leicester, with a 849
group of at least thirty physicians, screened for experience and skills, drawn from multiple specialties, including 850
paediatrics, oncology, anaesthesia, medicine & neurology. In addition, at least fifteen nurses, again screened for 851
experience and skills, were recruited, who have work experience in obstetrics, PACU, ICU, HDU. 852
‘Simulation rooms’ were set up: one to simulate a block-room, the second an HDU/ ICU room. The ‘block room’ 853
was equipped with a ‘spinal manikin’, to allow spinal and epidural injections to be made, epidural catheters 854
inserted and also, sampling and pressure measurement of CSF. The HDU/ICU ‘room’ was equipped with an 855
upper-body manikin, to permit line CONNECTION and misconnection attempts to be made by nurses and physicians. 856
Nurse participants were required to give bolus injections into the epidural and IV lines, set up enteral feeds, 857
neuraxial infusions, IV infusions, and bolus injections, non-invasive blood pressure measurements and oxygen 858
therapy. All procedures were videotaped for analysis, and all participants gave their consent to this. 859
Instructions for performing all tasks were prepared for physicians and nurses. Questionnaires were prepared to 860
assess usability using Likert scores. All procedures were observed and assistance by moderators was available 861
for participants. Post-task Interviews of all participants were held, and specific questions were asked of all 862
participants regarding usability and assess the change from Luer systems to non-Luer. 863
ISO/IEC DIS 80369-6
40 © ISO/IEC 2014 – All rights reserved
Final results to be communicated by ISO/TC 210/JWG4, Small-bore connectors, subsequent to the DIS vote. An 864
“N” document will circulate prior to the completion of the DIS balloting with results from the validation. 865
866
G.5 Summary of the design review 867
To be completed by ISO/TC 210/JWG4, Small-bore connectors, subsequent to the DIS vote. 868
869
ISO/IEC DIS 80369-6
© ISO/IEC 2014 – All rights reserved 41
Annex H 870
871
(informative) 872
873
Mechanical tests for verifying NON-INTERCONNECTABLE characteristics 874
H.1 * Purpose 875
ISO 80369-1:2010, Annex B, specifies the TEST METHOD and acceptance criteria to be used to obtain OBJECTIVE 876
EVIDENCE to demonstrate NON-INTERCONNECTABLE characteristics between a SMALL-BORE CONNECTOR being 877
evaluated and other SMALL-BORE CONNECTORS likely to be found in the environment around the PATIENT. This TEST 878
METHOD utilizes physical force testing between the CONNECTOR being evaluated and metal reference CONNECTORS 879
for each of the other SMALL-BORE CONNECTORS specified in this family of standards. This TEST METHOD forcefully 880
attempts to create a CONNECTION and then, should a CONNECTION occur, expects that the SMALL-BORE CONNECTOR 881
being evaluated and the reference CONNECTOR easily disengage from each other. 882
This standard modifies that TEST METHOD from ISO 80369-1:2010, Annex B, for neuraxial SMALL BORE CONNECTORS. Both the 883
detailed methodology of the test and the acceptance criteria are modified. 884
H.2 Requirement 885
The neuraxial SMALL-BORE CONNECTOR shall not appear to provide a secure CONNECTION when forcefully 886
assembled to any surface of the components of, and shall easily disengage from each SMALL-BORE CONNECTOR of 887
every other APPLICATION category specified in the ISO 80369-1:2010 or should a neuraxial CONNECTOR engage, 888
then greater than 75% of the infusate shall leak from the misconnection between the neuraxial CONNECTOR and 889
the reference SMALL-BORE CONNECTOR. 890
H.3 TEST METHOD 891
For the purposes of this test, the CONNECTORS above, other than the neuraxial CONNECTOR being evaluated, shall 892
be made of RIGID MATERIAL using nominal dimensions or may be reference CONNECTORS as specified in other 893
parts of this series of standards. 894
H.4 Test procedure, physical force 895
Check compliance with the following test. 896
a) Condition the CONNECTOR under test at 23 °C ±2 °C and a relative humidity of 50 % ±5 % for not less than 897
1 h. 898
b) Assemble the SMALL-BORE CONNECTOR to the reference CONNECTOR by applying an axial compressive force at 899
a rate of approximately 10 N/s not exceeding (70 ± 1) N and a simultaneous torque not exceeding 0,12 N·m 900
to a limit of no less than 270° of rotation or whichever comes first. 901
c) Hold the maximum assembly force and torque for no less than 10 s. 902
NOTE The requirement from ISO 80369-1:2010 was 70 N and a torque not exceeding 0,12 N·m to a limit of no more 903
than 90° of rotation. 904
ISO/IEC DIS 80369-6
42 © ISO/IEC 2014 – All rights reserved
d) Without activation of any latch or disengagement mechanism, apply an axial force of separation to the 905
assembled CONNECTORS to either 0,02 N or the weight of the part. 906
e) Confirm that the assembled CONNECTORS disengage. 907
f) If CONNECTORS do not disengage, without disrupting the CONNECTION, perform the CONNECTOR incompatibility 908
test (gross leak at misconnection) of H.5. 909
H.5 * Test procedure, CONNECTOR incompatibility (gross leakage) 910
H.5.1 Apparatus 911
The following items shall be utilized. 912
a) The male or female CONNECTOR under test. 913
b) The appropriate reference CONNECTOR. 914
c) An axial force meter and torque meter capable of measuring a simultaneous axial force of 70 N and 915
0.12 N·m. 916
d) A pressure source 917
EXAMPLE A syringe complying with ISO 7886-1. 918
e) A simulated or actual 22 gauge (0,42 mm inner diameter) x 90 mm spinal needle. 919
NOTE A length of hypodermic or similar tubing can be used to simulate the spinal needle such that the hypodermic 920
tubing has a maximum inner diameter of 0,43 mm and a length of (90 ± 3) mm. 921
f) A length of tubing able to create a leak proof seal between the CONNECTOR under test and the simulated 922
spinal needle 923
g) A weigh pan 924
h) A gram scale 925
H.5.2 Procedure 926
Check for CONNECTOR incompatibility with the following test. 927
a) Assemble the SMALL-BORE CONNECTOR to the reference CONNECTOR by applying an axial compressive force at 928
a rate of approximately 10 N/s not exceeding (70 ± 1) N and a simultaneous torque not exceeding 0,12 N·m 929
to a limit of no less than 270° of rotation or whichever comes first. 930
b) Hold the maximum assembly force and torque for no less than 10 s. 931
NOTE If the neuraxial CONNECTOR and reference CONNECTOR are pre-attached for the physical test described in 932
section H.4, they do not need to be assembled a second time. 933
c) Assemble the apparatus as shown in Figure H.1. 934
d) Prime the CONNECTOR under test, the reference CONNECTOR, connecting tubing and the simulated needle 935
with water by filling the circuit until water drips from the end of the needle. 936
e) Place a 10 ml syringe on the scale and zero the scale by pressing the tare button. 937
ISO/IEC DIS 80369-6
© ISO/IEC 2014 – All rights reserved 43
f) Fill the syringe with 7 ml ± 0.2 ml of water. 938
g) Weigh the filled syringe on the scale and record this weight as W1 (syringe water only) 939
h) Press the filled syringe into the reference CONNECTOR. 940
i) Confirm that the CONNECTION between the syringe and the reference CONNECTOR does not leak water during 941
the test. 942
j) Place the weigh pan onto the scale and zero the scale by pressing the tare button. 943
k) Place the weigh pan under the needle such that water that emerges from the needle will be collected in the 944
weigh pan. 945
l) Slowly depress the syringe plunger such that the water is fully expelled in 7 s to 15 s. 946
m) Weigh the pan with water collected from the end of the needle. Record this weight as W2. This represents 947
the water that did not leak from the misconnected CONNECTORS. 948
n) Calculate the percentage water leaking, Lw from the CONNECTION using Equation H.1. 949
Lw = 1(1 / ) 1002W W (H.1) 950
o) Confirm that the percent water leaking from the test CONNECTION exceeds 75 %. 951
952
Key 953
1. Pressure source (e.g. syringe) 954
2. Reference CONNECTOR 955
3. Neuraxial CONNECTOR under test 956
4. Tubing 957
5. 22 gauge (0,42 mm inner diameter) x 90 mm long hypodermic tube 958
6. Weigh pan 959
Figure H.1 — CONNECTOR incompatibility test set up 960
ISO/IEC DIS 80369-6
44 © ISO/IEC 2014 – All rights reserved
Annex I 961
962
(informative) 963
964
Reference to the Essential Principles 965
This document has been prepared to support the essential principles of safety and performance as intended to be 966
used for CONNECTIONS for neuraxial APPLICATIONS, according to ISO/TR 16142. This document is intended to be 967
acceptable for conformity assessment purposes. 968
Compliance with this document provides one means of demonstrating conformance with the specific essential 969
principles of ISO/TR 16142. Other means are possible. Table I.1 maps the clauses and subclauses of this 970
document with the essential principles of ISO/TR 16142:2006. 971
Table I.1 — Correspondence between this document and the essential principles (1 of 2) 972
Essential principle of ISO/TR 16142:2006
Corresponding clause(s)/sub-clause(s) of this document
Qualifying remarks/Notes
A.1 — Not applicable
A.2 — Not applicable
A.3 — Not applicable
A.4 — Not applicable
A.5 — Not applicable
A.6 — Not applicable
A.7.1 — Not applicable
A.7.2 — Not applicable
A.7.3 — Not applicable
A.7.4 — Not applicable
A.7.5 4, 5, 6
A.7.6 4, 5, 6
A.8.1 — Not applicable
A.8.1.1 — Not applicable
A.8.1.2 — Not applicable
A.8.2 — Not applicable
A.8.3 — Not applicable
A.8.4 — Not applicable
A.8.5 — Not applicable
A.8.6 — Not applicable
A.9.1 4, 5, 6
A.9.2 — Not applicable
A.9.3 — Not applicable
973
ISO/IEC DIS 80369-6
© ISO/IEC 2014 – All rights reserved 45
Table I.1 — (2 of 2) 974
Essential principle of ISO/TR 16142:2006
Corresponding clause(s)/sub-clause(s) of this document
Qualifying remarks/Notes
A.10.1 — Not applicable
A.10.2 — Not applicable
A.10.3 — Not applicable
A.11.1.1 — Not applicable
A.11.2.1 — Not applicable
A.11.2.2 — Not applicable
A.11.3.1 — Not applicable
A.11.4.1 — Not applicable
A.11.5.1 — Not applicable
A.11.5.2 — Not applicable
A.11.5.3 — Not applicable
A.12.1 — Not applicable
A.12.2 — Not applicable
A.12.3 — Not applicable
A.12.4 — Not applicable
A.12.5 — Not applicable
A.12.6 — Not applicable
A.12.7.1 — Not applicable
A.12.7.2 — Not applicable
A.12.7.3 — Not applicable
A.12.7.4 4, 5, 6
A.12.7.5 — Not applicable
A.12.8.1 — Not applicable
A.12.8.2 4, 5, 6
A.12.8.3 — Not applicable
A.13.1 — Not applicable
A.14.1 — Not applicable
975
976
ISO/IEC DIS 80369-6
46 © ISO/IEC 2014 – All rights reserved
Bibliography 977
[1] ISO 594-1:1986, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical 978
equipment – Part 1: General requirements 979
[2] ISO 3040:1990, Technical drawings — Dimensioning and tolerancing — Cones 980
[3] IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety and 981
essential performance 982
[4] IEC 60601-1-11:—, Medical electrical equipment – Part 1-11: General requirements for basic safety and 983
essential performance – Collateral Standard: Requirements for medical electrical equipment and medical 984
electrical systems used in the home healthcare environment 985
[5] CEN CR 13825, Luer connectors - A report to CEN CHeF from the CEN forum task group “Luer fittings” 986
[6] Department of Health (England). HSC 2008/001: Updated national guidance on the safe administration of 987
intrathecal chemotherapy. 2008. Available at988
http://www.dh.gov.uk/en/Publicationsandstatistics/Lettersandcirculars/Healthservicecirculars/DH_086870 989
[7] COOK T.M. et al. A simulation based evaluation of two proposed alternatives to Luer devices for use in 990
Neuraxial anaesthesia, Anaesthesia 2010 65, pp. 1074 991
[8] Drake JM and Crawford MW. Near-miss injection of an anesthetic agent into a cerebrospinal fluid external 992
ventricular drain: special report. Neurosurgery 2005; 56:E1161 993
[9] Food and Drug Administration. Look, Check and Connect. Safe medical device connections save lives. 994
Medical Devices Calendar 2009. Available at http://www.fda.gov/CDRH/luer/casestudies2009-luer.pdf 995
[10] GOODMAN EJ, HAAS AJ, KANTOR GS. Inadvertent administration of magnesium sulphate through the 996
epidural catheter; report and analysis of a drug error. In J Obstet Anesth 2006; 15: 63-7 997
[11] HEW CM, CYNA AM, SIMMONS SW. Avoiding inadvertent epidural injection of drugs intended for epidural 998
use. Anaesth Intensive Care 2003, 31: 44-29 999
[12] Institute for Safe Medication Practices – Canada. Safety Bulletin. Published data supports dispensing 1000
vincristine in minibags as a system safeguard. 3rd October 2001. Available at http://www.ismp-1001
canada.org/download/safetyBulletins/ISMPCSB2001-10vincristine.pdf 1002
[13] JONES R, SWALES HA, LYONS GR. A national survey of safe practice with epidural analgesia in obstetric 1003
units, Anaesthesia 2008; 63:516-9 1004
[14] KARACA S, UNLUSOV EO. Accidental injection of intravenous bupivacaine. Eur J Anaesthesiol 2002; 1005
19:616-7 1006
[15] KHAN EI, KHADIJAH I. Intravenous bupivacaine infusion; an error in administration – a case report. Middle 1007
East Journal of Anaesthesia 2008;19:1399-400 1008
[16] National Patient Safety Agency. Patient Safety Alert 21. Safer Practice with Epidural Injections and 1009
Infusions. 2007. Available at 1010
http://www.npsa.nhs.uk/nrls/alerts-and-directives/alerts/epidural-injections-and-infusions/ 1011
[17] New South Wales Health. Safety Alert 04/06. Safe Use of vincristine. August 2006. Available at 1012
http://www.health.nsw.gov.au/quality/sabs/pdf/vincristine0906.pdf 1013
ISO/IEC DIS 80369-6
© ISO/IEC 2014 – All rights reserved 47
[18] The Joint Commission (USA)/ Sentinel Event Alert. Preventing vincristine administration errors. 14th July 1014
2005. Available at 1015
http://www.jointcommission.org/SentinelEvents/SentinelEventAlert/sea_34.htm 1016
[19] The Telegraph, Calcutta, India. Cancer patient dies after wrong injection. 10th July 2008. Available at 1017
http://www.telegraphindia.com/1080710/jsp/calcutta/story_9527857.jsp 1018
[20] World Health Organisation. Information Exchange system. Alert 115. Vincristine (and other vinca 1019
alkaloids) should only be given intravenously via a minibag. July 2007. Available at 1020
http://www.who.int/patientsafety/highlights/PS_alert_115_vincristine.pdf 1021
1022
ISO/IEC DIS 80369-6
48 © ISO/IEC 2014 – All rights reserved
Terminology - Alphabetized index of defined terms 1023
ACCESSORY ..................................................................................................... ISO 80369-1:2010, definition 3.1 1024
APPLICATION .................................................................................................... ISO 80369-1:2010, definition 3.2 1025
CONNECTION ................................................................................................... ISO 80369-1:2010, definition 3.4 1026
CONNECTOR .................................................................................................... ISO 80369-1:2010, definition 3.5 1027
HARM ............................................................................................................. ISO 14971:2007, definition 2.2 1028
INTENDED USE ...................................................................................................... ISO 14971:2007, definition 2.5 1029
LOCK CONNECTOR ........................................................................................................................................... 3.1 1030
MANUFACTURER ................................................................................................... ISO 14971:2007, definition 2.8 1031
MEDICAL DEVICE ................................................................................................... ISO 14971:2007, definition 2.9 1032
NON-INTERCONNECTABLE ................................................................................. ISO 80369-1:2010, definition 3.6 1033
NORMAL USE ................................................................................................................................................... 3.2 1034
PATIENT .......................................................................................................... ISO 80369-1:2010, definition 3.7 1035
PROCEDURE ...................................................................................................... ISO 14971:2007, definition 2.12 1036
PROCESS ....................................................................................................... ISO 80369-1:2010, definition 3.17 1037
RATED ......................................................................................................................................................... 3.3 1038
RESPONSIBLE ORGANIZATION ............................................................................ ISO 80369-1:2010, definition 3.8 1039
RISK ........................................................................................................... ISO 14971:2007, definition 2.16 1040
RISK ANALYSIS .................................................................................................... ISO 14971:2007, definition 2.17 1041
RISK MANAGEMENT FILE ...................................................................................... ISO 14971:2007, definition 3.23 1042
RIGID MATERIAL ................................................................................................ ISO 80369-1:2010, definition 3.9 1043
SEMI-RIGID MATERIAL ...................................................................................... ISO 80369-1:2010, definition 3.10 1044
SLIP CONNECTOR ............................................................................................................................................ 3.4 1045
SMALL-BORE .................................................................................................. ISO 80369-1:2010, definition 3.11 1046
TYPE TEST .......................................................................................................... ISO 80369-20:—, definition 3.2 1047
USER ......................................................................................................................................................... 3.5 1048
USER PROFILE ................................................................................................................................................. 3.6 1049
VERIFICATION ..................................................................................................... ISO 14971:2007, definition 2.28 1050
1051
ISO/IEC DIS 80369-6
© ISO/IEC 2014 – All rights reserved 49
Annex ZA 1052
1053
(informative) 1054
1055
Relationship between this Document and the Essential Requirements of EU 1056
Directive 93/42/EEC 1057
[Secretariats Note: This “strawman” Annex ZA is included as a placeholder only. A formal proposal regarding this 1058
Annex will be prepared by CEN for inclusion in the Enquiry version of this part of ISO 80369. Annex ZA only 1059
applies to the CEN version of this standard and will not be included in the final ISO standard. Comments on 1060
Annex ZA should be sent to CEN for consideration and not included with national member comments on the ISO 1061
standard.] 1062
By agreement between ISO and CEN, this CEN Annex is included in the DIS and the FDIS but will not appear in 1063
the published ISO document. 1064
This document has been prepared under a mandate given to CEN by the European Commission and the 1065
European Free Trade Association to provide a means to conforming to Essential Requirements of the New 1066
Approach Directive 93/42/EEC, Council Directive of 14 June 1993 on the approximation of the laws of the 1067
Member States concerning medical devices” (Medical Device Directive). 1068
Once this document is cited in the Official Journal of the European Communities under that Directive and has 1069
been implemented as a national standard in at least one Member State, compliance with the clauses of this 1070
document given in Table ZA.1 confers, within the limits of the scope of this document, a presumption of 1071
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations. 1072
Table ZA.1 — Correspondence between this document and Directive 93/42/EEC 1073
Clause(s)/sub-clause(s) of this Document
Essential requirements (ERs) of EU Directive 93/42/EEC
Qualifying remarks/Notes
4, 5, 6 7.5
4, 5, 6 7.6
4, 5, 6 9.1
4, 5, 6 12.7.4
4, 5, 6 12.8.1
1074
WARNING: Other requirements and other EU Directives may be applicable to the products falling within the 1075
scope of this document. 1076
For devices which are also machinery within the meaning of Article 2(a) of Directive 2006/42/EC on Machinery, in 1077
accordance with Article 3 of Directive 93/42/EEC the following Table ZA.2 details the relevant essential health 1078
and safety requirements of Directive 2006/42/EC on Machinery to the extent to which they are more specific than 1079
those of Directive 93/42/EEC along with the corresponding clauses of this Document. Table ZA.2, however, does 1080
not imply any citation in the OJEU under the machinery directive and thus does not provide presumption of 1081
conformity for the machinery directive. 1082
ISO/IEC DIS 80369-6
50 © ISO/IEC 2014 – All rights reserved
Table ZA.2 — Relevant Essential Health and Safety Requirements (EHSRs) from Directive 2006/42/EC on 1083
machinery that are addressed by this document 1084
Clause(s)/sub-clause(s) of this Document
EHSR of 2006/42/EC Qualifying remarks/Notes
4, 5, 6 1.5.4
1085
1086