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Draft List of Recognized Standards for Medical Devices
This guidance document is being distributed for comment purposes only.
Draft date: 2021/01/15
Draft: List of Recognized Standards for Medical Devices | 2
Health Canada is responsible for helping Canadians maintain and improve their health. It ensures that high-quality health services are accessible, and works to reduce health risks.
Également disponible en français sous le titre : Ébauche : Normes reconnues pour les instruments médicaux
© Her Majesty the Queen in Right of Canada, as represented by the Minister of Health, 2020
Publication date: April 2020
This publication may be reproduced for personal or internal use only without permission provided the source is fully acknowledged.
Draft: List of Recognized Standards for Medical Devices | 3
Foreword
Guidance documents are meant to provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. Guidance documents also provide assistance to staff on how Health Canada mandates and objectives should be implemented in a manner that is fair, consistent, and effective.
Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach. Alternate approaches to the principles and practices described in this document may be acceptable provided they are supported by adequate justification. Alternate approaches should be discussed in advance with the relevant programme area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.
As a corollary to the above, it is equally important to note that Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, in order to allow the Department to adequately assess the safety, efficacy, or quality of a therapeutic product. Health Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented.
This document should be read in conjunction with the accompanying notice and the relevant sections of other applicable Guidance documents.
Draft: List of Recognized Standards for Medical Devices | 4
Table of contents 1
Changes to the List of Recognized Standards ............................................................................ 5 2
Standards Added .................................................................................................................... 5 3
Standards Updated................................................................................................................. 6 4
Standards Removed ............................................................................................................... 9 5
List of Recognized Standards ...................................................................................................... 9 6
Anaesthetic and Respiratory ................................................................................................. 9 7
Biocompatibility ................................................................................................................... 11 8
Cardiovascular ...................................................................................................................... 13 9
Contraception ....................................................................................................................... 15 10
Dental ................................................................................................................................... 15 11
Electromedical ...................................................................................................................... 17 12
General ................................................................................................................................. 22 13
In Vitro Diagnostic ................................................................................................................ 24 14
Manufacturing ...................................................................................................................... 27 15
Materials ............................................................................................................................... 29 16
Neurology ............................................................................................................................. 34 17
Ophthalmology ..................................................................................................................... 35 18
Orthopaedics ........................................................................................................................ 37 19
Radiology .............................................................................................................................. 41 20
Sterilization ........................................................................................................................... 43 21
22
23
Draft: List of Recognized Standards for Medical Devices | 5
Changes to the List of Recognized Standards 24
Standards Added 25
ISO 25539-2:2012-Ed.2.0 26
Cardiovascular implants - Endovascular devices - Part 2: Vascular stents 27
ISO 13116:2014-Ed.1.0 28
Dentistry — Test Method for Determining Radio-Opacity of Materials 29
ISO 29022:2013-Ed.1.0 30
Dentistry — Adhesion — Notched-edge shear bond strength test 31
IEC 60601-2-1:2014-Ed.3.1 32
Medical electrical equipment - Part 2-1: Particular requirements for the basic safety 33 and essential performance of electron accelerators in the range 1 MeV to 50 MeV 34
IEC 62366-1:2015-Ed.1.0 35
Medical devices - Part 1: Application of usability engineering to medical devices 36
IEC 62366-1/COR 1:2016 37
ASTM F2026-16 38
Standard specification for polyetheretherketone (PEEK) polymers for surgical 39 implant applications 40
ISO 11979-4:2008-Ed.2.0 41
Ophthalmic implants - Intraocular lenses - Part 4: Labelling and information 42
ISO 11979-4/Amd.1:2012 43
ISO 11979-10:2018-Ed.2.0 44
Ophthalmic implants - Intraocular lenses - Part 10: Clinical investigations of 45 intraocular lenses for correction of ametropia in phakic eyes 46
ISO TR 22979:2017-Ed.2.0 47
Ophthalmic implants - Intraocular lenses - Guidance on assessment of the need for 48 clinical investigation of intraocular lens design modifications 49
ASTM F2083-12 50
Standard specification for knee replacement prosthesis 51
ASTM F2346-11 52
Standard test methods for static and dynamic characterization of spinal artificial 53 discs 54
55
Draft: List of Recognized Standards for Medical Devices | 6
ASTM F3140-17 56
Standard test method for cyclic fatigue testing of metal tibial tray components of 57 unicondylar knee joint replacements 58
ASTM F543-17 59
Standard Specification and Test Methods for Metallic Medical Bone Screws 60
IEC 60601-2-45:2015-Ed.3.1 61
Medical electrical equipment – Part 2-45: Particular requirements for the basic 62 safety and essential performance of mammographic X-ray equipment and 63 mammographic stereotactic devices 64
Standards Updated 65
ISO 7199:2016-Ed.3.0 66
Cardiovascular implants and artificial organs – Blood-gas exchangers (oxygenators) 67
ISO 10993-1:2018-Ed.5.0 68
Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk 69 management process 70
Note: Devices subject to Clause 5.3.2 may require additional testing beyond that 71 which is specified in Clause 5.3.2 72
ISO 10555-1:2013-Ed.2.0 73
Intravascular catheters - Sterile and single-use catheters - Part 1: General 74 requirements 75
ISO 10555-1/Amd.1:2017 76
ISO 25539-1:2017-Ed.2.0 77
Cardiovascular implants – Endovascular devices – Part 1: Endovascular prostheses 78
ISO 4049:2019-Ed.5.0 79
Dentistry – Polymer-based restorative materials 80
ISO 6872:2015-Ed.4.0 81
Dentistry – Ceramic materials 82
ISO 6872/Amd.1:2018 83
ISO 6874:2015-Ed.3.0 84
Dentistry – Polymer-based pit and fissure sealants 85
ISO 7405:2018-Ed.3.0 86
Dentistry – Evaluation of biocompatibility of medical devices used in dentistry 87
88
Draft: List of Recognized Standards for Medical Devices | 7
ISO 9917-2:2017-Ed.3.0 89
Dentistry - Water-based cements – Part 2: Resin-modified cements 90
ISO 14801:2016-Ed.3.0 91
Dentistry — Implants — Dynamic loading test for endosseous dental implants 92
ISO 22674:2016-Ed.2.0 93
Dentistry – Metallic materials for fixed and removable restorations and appliances 94
ISO 24234:2015-Ed.2.0 95
Dentistry — Dental amalgam 96
ISO/TS 11405:2015-Ed.3.0 97
Dental materials – Testing of adhesion to tooth structure 98
IEC 60601-2-22:2012-Ed.3.1 99
Medical electrical equipment – Part 2-22: Particular requirements for basic safety 100 and essential performance of surgical, cosmetic, therapeutic and diagnostic laser 101 equipment 102
ISO 14708-3:2017-Ed.2.0 103
Implants for Surgery - Active implantable medical devices -- Part 3: Implantable 104 neurostimulators 105
ISO 11979-8:2017-Ed.3.0 106
Ophthalmic implants – Intraocular lenses – Part 8: Fundamental requirements 107
ASTM F1044-05 108
Standard test method for shear testing of calcium phosphate coatings and metallic 109 coatings 110
ASTM F1044-05/(R 2017) 111
ASTM F1044-05/(E 2018) 112
ASTM F1147-05 113
Standard test method for tension testing of calcium phosphate and metal coatings 114
ASTM F1147-05/(R 2017) 115
ASTM F1147-05/(E 2017) 116
ASTM F1717-18 117
Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model 118
ASTM F1801-97 119
Standard practice for corrosion fatigue testing of metallic implant materials 120
ASTM F1801-97/(R 2014) 121
Draft: List of Recognized Standards for Medical Devices | 8
ASTM F2077-18 122
Test Methods for Intervertebral Body Fusion Devices 123
ASTM F2267-04 124
Standard Test Method for Measuring Load Induced Subsidence of Intervertebral 125 Body Fusion Device under Static Axial Compression 126
ASTM F2267-04 /(R 2018) 127
ASTM F746-04 128
Standard test method for pitting or crevice corrosion of metallic surgical implant 129 materials 130
ASTM F746-04 /(R 2014) 131
ISO 14242-1:2014-Ed.3.0 132
Implants for surgery — Wear of total hip-joint prostheses — Part 1: Loading and 133 displacement parameters for wear-testing machines and corresponding 134 environmental conditions for test 135
ISO 14242-1/Amd. 1: 2018 136
ISO 14242-2:2016-Ed.2.0 137
Implants for Surgery - Wear of total hip-joint prostheses - Part 2: Methods of 138 measurement 139
ISO 14243-2:2016-Ed.3.0 140
Implants for surgery - Wear of total knee-joint prostheses - Part 2: Methods of 141 measurement 142
ISO 14243-3:2014-Ed.2.0 143
Implants for surgery — Wear of total knee-joint prostheses — Part 3: Loading and 144 displacement parameters for wear-testing machines with displacement control and 145 corresponding environmental conditions for test 146
IEC 60601-2-28:2017-Ed.3.0 147
Medical electrical equipment – Part 2-28: Particular requirements for the basic 148 safety and essential performance of X-ray tube assemblies for medical diagnosis 149
IEC 60601-2-43:2017-Ed.2.1 150
Medical electrical equipment – Part 2-43: Particular requirements for the basic 151 safety and essential performance of X-ray equipment for interventional procedures 152
IEC 60601-2-43/Amd.1:2017 153
154
Draft: List of Recognized Standards for Medical Devices | 9
ISO 11135:2014-Ed.2.0 155
Sterilization of health care products – Ethylene oxide – Requirements for the 156 development, validation and routine control of a sterilization process for medical 157 devices 158
ISO 11135/Amd.1:2018 159
Standards Removed 160
ISO 9693:1999 161
Metal-ceramic dental restorative systems 162
ISO 9693/Amd.1:2005 163
IEC 60601-1-2:2007-Ed.3.0 164
Medical electrical equipment – Part 1-2: General requirements for basic safety and 165 essential performance – Collateral standard: Electromagnetic compatibility – 166 Requirements and tests 167
IEC 62366:2014-Ed.1.1 168
Medical devices – Application of usability engineering to medical devices 169
List of Recognized Standards 170
Anaesthetic and Respiratory 171
ASME PVHO-1:2007 172
Safety standard for pressure vessels for human occupancy 173
ISO 5356-1:2015-Ed.4.0 174
Anaesthetic and Respiratory Equipment - Conical Connectors - Part 1: Cones and 175 Sockets 176
ISO 5356-2:2012-Ed.3.0 177
Anaesthetic and Respiratory Equipment - Conical Connectors - Part 2: Screw 178 threaded weight bearing connectors 179
ISO 5360:2012-Ed.3.0 180
Anaesthetic Vaporizers - Agent Specific Filling System 181
Draft: List of Recognized Standards for Medical Devices | 10
ISO 7199:2016-Ed.3.0 182
Cardiovascular implants and artificial organs – Blood-gas exchangers (oxygenators) 183
ISO 8359:1996-Ed.2.0 184
Oxygen Concentrators for medical use - Safety requirements 185
ISO 8359:1996-Ed.2.0/Amd.1:2012 186
ISO 80601-2-12:2011-Ed.1.0 187
Medical electrical equipment – Part 2-12: Particular requirements for basic safety 188 and essential performance of critical care ventilators 189
ISO 80601-2-12:2011-Ed.1.0/Cor.1:2011 190
ISO 80601-2-13:2011-Ed.1.0 191
Medical electrical equipment – Part 2-13: Particular requirements for basic safety 192 and essential performance of an anaesthetic workstation 193
ISO 80601-2-13:2011-Ed.1.0/Amd.1:2015 194
ISO 80601-2-55:2011-Ed.1.0 195
Medical electrical equipment – Part 2-55: Particular requirements for the basic 196 safety and essential performance of respiratory gas monitors 197
ISO 80601-2-61:2011-Ed.1.0 198
Medical electrical equipment – Part 2-61: Particular requirements for basic safety 199 and essential performance of pulse oximeter equipment 200
ISO 80601-2-72:2015-Ed.1.0 201
Medical electrical equipment – Part 2-72: Particular requirements for basic safety 202 and essential performance of home healthcare environment ventilators for 203 ventilator-dependent patients 204
205
Draft: List of Recognized Standards for Medical Devices | 11
Biocompatibility 206
ASTM F981-04 207
Standard practice for assessment of compatibility of biomaterials for surgical 208 implants with respect to effect of materials on muscle and bone 209
ISO 10993-1:2018-Ed.5.0 210
Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk 211 management process 212
Note: Devices subject to Clause 5.3.2 may require additional testing beyond that 213 which is specified in Clause 5.3.2 214
ISO 10993-2:2006-Ed.2.0 215
Biological evaluation of medical devices – Part 2: Animal welfare requirements 216
ISO 10993-3:2003-Ed.2.0 217
Biological evaluation of medical devices – Part 3: Tests for genotoxicity, 218 carcinogenicity and reproductive toxicity 219
ISO 10993-4:2002-Ed.2.0 220
Biological evaluation of medical devices – Part 4: Selection of tests for interactions 221 with blood 222
ISO 10993-4:2002-Ed.2.0/Amd.1:2006 223
ISO 10993-5:2009-Ed.3.0 224
Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity 225
ISO 10993-6:2007-Ed.2.0 226
Biological evaluation of medical devices – Part 6: Tests for local effects after 227 implantation 228
ISO 10993-7:2008-Ed.2.0 229
Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization 230 residuals 231
ISO 10993-7:2008-Ed.2.0/Cor.1:2009 232
Draft: List of Recognized Standards for Medical Devices | 12
ISO 10993-9:2009-Ed.2.0 233
Biological evaluation of medical devices – Part 9: Framework for identification and 234 quantification of potential degradation products 235
ISO 10993-10:2010-Ed.3.0 236
Biological evaluation of medical devices – Part 10: Tests for irritation and skin 237 sensitization 238
ISO 10993-11:2006-Ed.2.0 239
Biological evaluation of medical devices – Part 11: Tests for systemic toxicity 240
ISO 10993-12:2007-Ed.3.0 241
Biological evaluation of medical devices – Part 12: Sample preparation and reference 242 materials 243
ISO 10993-13:2010-Ed.2.0 244
Biological evaluation of medical devices – Part 13: Identification and quantification 245 of degradation products from polymeric medical devices 246
ISO 10993-14:2001-Ed.1.0 247
Biological evaluation of medical devices – Part 14: Identification and quantification 248 of degradation products from ceramics 249
ISO 10993-15:2000-Ed.1.0 250
Biological evaluation of medical devices – Part 15: Identification and quantification 251 of degradation products from metals and alloys 252
ISO 10993-16:2010-Ed.2.0 253
Biological evaluation of medical devices – Part 16: Toxicokinetic study design for 254 degradation products and leachables 255
ISO 10993-17:2002-Ed.1.0 256
Biological evaluation of medical devices – Part 17: Establishment of allowable limits 257 for leachable substances 258
259
Draft: List of Recognized Standards for Medical Devices | 13
ISO 10993-18:2005-Ed.1.0 260
Biological evaluation of medical devices – Part 18: Chemical characterization of 261 materials 262
Cardiovascular 263
ISO 5840-1:2015-Ed.1.0 264
Cardiovascular implants - Cardiovascular implants - Cardiac valve prostheses - Part 1: 265 General requirements 266
ISO 5840-2:2015-Ed.1.0 267
Cardiovascular implants - Cardiac valve prostheses - Part 2: Cardiovascular implants - 268 Surgically implanted heart valve substitutes 269
ISO 5840-3:2013-Ed.1.0 270
Cardiovascular implants — Cardiac valve prostheses — Part 3: Heart valve 271 substitutes implanted by transcatheter techniques 272
ISO 5841-3:2013-Ed.3.0 273
Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors (IS-1) for 274 implantable pacemakers 275
ISO 7198:2016-Ed.2.0 276
Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular 277 vascular grafts and vascular patches 278
ISO 10555-1:2013-Ed.2.0 279
Intravascular catheters - Sterile and single-use catheters - Part 1: General 280 requirements 281
ISO 10555-1:2013-Ed.2.0/Amd.1:2017 282
ISO 10555-3:2013-Ed.2.0 283
Intravascular catheters - Sterile and single-use catheters - Part 3: Central venous 284 catheters 285
286
Draft: List of Recognized Standards for Medical Devices | 14
ISO 10555-4:2013-Ed.2.0 287
Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation 288 catheters 289
ISO 10555-5:2013-Ed.2.0 290
Intravascular catheters - Sterile and single-use catheters - Part 5: Over-needle 291 peripheral catheters 292
ISO 11318:2002-Ed.2.0 293
Cardiac defibrillators – Connector assembly DF-1 for implantable defibrillators - 294 Dimensions and test requirements 295
ISO 14117:2012-Ed.1.0 296
Active implantable medical devices - Electromagnetic compatibility - EMC test 297 protocols for implantable cardiac pacemakers, implantable cardioverter 298 defibrillators and cardiac resynchronization devices 299
ISO 14708-2:2012-Ed.2.0 300
Implants for surgery – Active implantable medical devices – Part 2: Cardiac 301 pacemakers 302
ISO 14708-5:2010-Ed.1.0 303
Implants for surgery – Active implantable medical devices – Part 5: Circulatory 304 support devices 305
ISO 14708-6:2010-Ed.1.0 306
Implants for surgery - Active implantable medical devices - Part 6: Particular 307 requirements for active implantable medical devices intended to treat 308 tachyarrhythmia (including implantable defibrillators) 309
ISO 25539-1:2017-Ed.2.0 310
Cardiovascular implants – Endovascular devices – Part 1: Endovascular prostheses 311
ISO 25539-2:2012-Ed.2.0 312
Cardiovascular implants - Endovascular devices - Part 2: Vascular stents 313
314
Draft: List of Recognized Standards for Medical Devices | 15
ISO 27186:2010-Ed.1.0 315
Active implantable medical devices – Four-pole connector system for implantable 316 cardiac rhythm management devices – Dimensional and test requirements 317
Contraception 318
ISO 4074:2002-Ed.1.0 319
Natural latex rubber condoms – Requirements and test methods 320
ISO 4074:2002-Ed.1.0/Cor.1:2003 321
ISO 4074:2002-Ed.1.0/Cor.2:2008 322
Dental 323
ISO 3107:2011-Ed.4.0 324
Dentistry – Zinc oxide/eugenol and zinc oxide/non-eugenol cements 325
ISO 4049:2019-Ed.5.0 326
Dentistry – Polymer-based restorative materials 327
ISO 6872:2015-Ed.4.0 328
Dentistry – Ceramic materials 329
ISO 6872:2015-Ed.4.0/Amd.1:2018 330
ISO 6874:2015-Ed.3.0 331
Dentistry – Polymer-based pit and fissure sealants 332
ISO 6876:2012-Ed.3.0 333
Dental root canal sealing materials 334
ISO 6877:2006-Ed.2.0 335
Dentistry – Root-canal obturating points 336
ISO 7405:2018-Ed.3.0 337
Dentistry – Evaluation of biocompatibility of medical devices used in dentistry 338
Draft: List of Recognized Standards for Medical Devices | 16
ISO 9693-1:2012-Ed.1.0 339
Dentistry – Compatibility testing – Part 1: Metal-ceramic systems 340
ISO 9917-1:2007-Ed.2.0 341
Dentistry – Water-based cements – Part 1: Powder/liquid acid-base cements 342
ISO 9917-2:2017-Ed.3.0 343
Dentistry - Water-based cements – Part 2: Resin-modified cements 344
ISO 10271:2011-Ed.2.0 345
Dental metallic materials – Corrosion test methods for metallic materials 346
ISO 14801:2016-Ed.3.0 347
Dentistry — Implants — Dynamic loading test for endosseous dental implants 348
ISO 22674:2016-Ed.2.0 349
Dentistry – Metallic materials for fixed and removable restorations and appliances 350
ISO 22794:2007-Ed.1.0 351
Dentistry – Implantable materials for bone filling and augmentation in oral and 352 maxillofacial surgery – Contents of a technical file 353
ISO 22803:2004-Ed.1.0 354
Dentistry – Membrane materials for guided tissue regeneration in oral and 355 maxillofacial surgery – Contents of a technical file 356
ISO 24234:2015-Ed.2.0 357
Dentistry –Dental amalgam 358
ISO/TS 11405:2015-Ed.3.0 359
Dental materials – Testing of adhesion to tooth structure 360
ISO 13116:2014-Ed.1.0 361
Dentistry - Test Method for Determining Radio-Opacity of Materials 362
363
Draft: List of Recognized Standards for Medical Devices | 17
ISO 29022:2013-Ed.1.0 364
Dentistry - Adhesion - Notched-edge shear bond strength test 365
Electromedical 366
CAN/CSA C22.2 NO 60601-1-14:2014-Ed.3.0 367
Medical electrical equipment – Part 1: General requirements for basic safety and 368 essential performance 369
IEC 60529:2001-Ed.2.1 370
Degrees of protection provided by enclosures (IP Code) 371
IEC 60529:2001-Ed.2.1/Cor.1:2001 372
IEC 60529:2001-Ed.2.1/Cor.2:2007 373
IEC 60529:2001-Ed.2.1/Cor.3:2009 374
IEC 60601-1:2005-Ed.3.0 375
Medical electrical equipment – Part 1: General requirements for basic safety and 376 essential performance 377
IEC 60601-1:2005-Ed.3.0/Cor.1:2006 378
IEC 60601-1:2005-Ed.3.0/Cor.2:2007 379
IEC 60601-1:2012-Ed.3.1 380
Medical electrical equipment – Part 1: General requirements for basic safety and 381 essential performance 382
IEC 60601-1-2:2014-Ed.4.0 383
Medical electrical equipment – Part 1-2: General requirements for basic safety and 384 essential performance – Collateral standard: Electromagnetic disturbances – 385 Requirements and tests 386
IEC 60601-1-6:2013-Ed.3.1 387
Medical electrical equipment – Part 1-6: General requirements for basic safety and 388 essential performance – Collateral standard: Usability 389
Draft: List of Recognized Standards for Medical Devices | 18
IEC 60601-1-8:2012-Ed.2.1 390
Medical electrical equipment – Part 1-8: General requirements for basic safety and 391 essential performance – Collateral Standard: General requirements, tests and 392 guidance for alarm systems in medical electrical equipment and medical electrical 393 systems 394
IEC 60601-1-10:2007-Ed 1.0 395
Medical electrical equipment - Part 1-10: General requirements for basic safety and 396 essential performance – Collateral Standard: Requirements for the development of 397 physiologic closed-loop controllers 398
IEC 60601-1-11:2010 -Ed 1.0 399
Medical electrical equipment – Part 1-11: General requirements for basic safety and 400 essential performance – Collateral Standard: Requirements for medical electrical 401 equipment and medical electrical systems used in the home healthcare environment 402
IEC 60601-2-1:2014-Ed.3.1 403
Medical electrical equipment - Part 2-1: Particular requirements for the basic safety 404 and essential performance of electron accelerators in the range 1 MeV to 50 MeV 405
IEC 60601-2-2:2009-Ed.5.0 406
Medical electrical equipment – Part 2-2: Particular requirements for the basic safety 407 and essential performance of high frequency surgical equipment and high frequency 408 surgical accessories 409
IEC 60601-2-4:2010-Ed.3.0 410
Medical electrical equipment – Part 2-4: Particular requirements for the basic safety 411 and essential performance of cardiac defibrillators 412
IEC 60601-2-5:2009-Ed.3.0 413
Medical electrical equipment – Part 2-5: Particular requirements for the basic safety 414 and essential performance of ultrasonic physiotherapy equipment 415
416
Draft: List of Recognized Standards for Medical Devices | 19
IEC 60601-2-16:2008-Ed.3.0 417
Medical electrical equipment – Part 2-16: Particular requirements for basic safety 418 and essential performance of haemodialysis, haemodiafiltration and haemofiltration 419 equipment 420
IEC 60601-2-16:2008-Ed.3.0/Cor.1:2008 421
IEC 60601-2-18:2009-Ed.3.0 422
Medical electrical equipment – Part 2-18: Particular requirements for the basic 423 safety and essential performance of endoscopic equipment 424
IEC 60601-2-22:2012-Ed.3.1 425
Medical electrical equipment – Part 2-22: Particular requirements for basic safety 426 and essential performance of surgical, cosmetic, therapeutic and diagnostic laser 427 equipment 428
IEC 60601-2-23:2011-Ed.3.0 429
Medical electrical equipment – Part 2-23: Particular requirements for the basic 430 safety and essential performance of transcutaneous partial pressure monitoring 431 equipment 432
IEC 60601-2-24:2012-Ed.2.0 433
Medical electrical equipment – Part 2-24: Particular requirements for the basic 434 safety and essential performance of infusion pumps and controllers 435
Note: Additional accuracy testing results for flow rates below 1 ml/h may be 436 required depending on the pump's intended use 437
IEC 60601-2-25:2011-Ed.2.0 438
Medical electrical equipment – Part 2-25: Particular requirements for the basic 439 safety and essential performance of electrocardiographs 440
IEC 60601-2-26:2012-Ed.3.0 441
Medical electrical equipment – Part 2-26: Particular requirements for the basic 442 safety and essential performance of electroencephalographs 443
444
Draft: List of Recognized Standards for Medical Devices | 20
IEC 60601-2-27:2011-Ed.3.0 445
Medical Electrical Equipment – Part 2-27: Particular Requirements for the Basic 446 Safety and Essential Performance of Electrocardiographic Monitoring Equipment 447
IEC 60601-2-27:2011-Ed.3.0/Cor.1:2012 448
IEC 60601-2-31:2008-Ed.2.0 449
Medical electrical equipment – Part 2-31: Particular requirements for the basic 450 safety and essential performance of external cardiac pacemakers with internal 451 power source 452
IEC 60601-2-31:2008-Ed.2.0/Amd.1:2011 453
IEC 60601-2-33:2010-Ed.3.0 454
Medical electrical equipment – Part 2-33: Particular requirements for the basic 455 safety and essential performance of magnetic resonance equipment for medical 456 diagnosis 457
IEC 60601-2-33:2010-Ed.3.0/Cor.1:2012 458
IEC 60601-2-34:2011-Ed.3.0 459
Medical electrical equipment – Part 2-34: Particular requirements for the basic 460 safety and essential performance of invasive blood pressure monitoring equipment 461
IEC 60601-2-47:2012-Ed.2.0 462
Medical electrical equipment – Part 2-47: Particular requirements for the basic 463 safety and essential performance of ambulatory electrocardiographic systems 464
IEC 60601-2-49:2011-Ed.2.0 465
Medical electrical equipment – Part 2-49: Particular requirements for the basic 466 safety and essential performance of multifunction patient monitoring equipment 467
IEC 60601-2-50:2009-Ed.2.0 468
Medical electrical equipment – Part 2-50: Particular requirements for the basic 469 safety and essential performance of infant phototherapy equipment 470
IEC 60601-2-50:2009-Ed.2.0/Cor.1:2010 471
472
Draft: List of Recognized Standards for Medical Devices | 21
IEC 60601-2-57:2011-Ed.1.0 473
Medical electrical equipment – Part 2-57: Particular requirements for the basic 474 safety and essential performance of non-laser light source equipment intended for 475 therapeutic, diagnostic, monitoring and cosmetic/aesthetic use 476
IEC 60825-1:2014-Ed.3.0 477
Safety of laser products - Part 1: Equipment classification and requirements 478
IEC 61000-3-2:2009-Ed.3.2 479
Electromagnetic compatibility (EMC) – Part 3-2: Limits – Limits for harmonic current 480 emissions (equipment input current ≤ 16 A per phase) 481
IEC 61000-3-2:2009-Ed.3.2/Cor.1:2009 482
IEC 61000-3-3:2008-Ed.2.0 483
Electromagnetic compatibility (EMC) – Part 3-3: Limits – Limitation of voltage 484 changes, voltage fluctuations and flicker in public low-voltage supply systems, for 485 equipment with rated current ≤16A per phase and not subject to conditional 486 connection 487
IEC 61000-4-2:2008-Ed.2.0 488
Electromagnetic compatibility (EMC) – Part 4-2: Testing and measurement 489 techniques – Electrostatic discharge immunity test 490
IEC 61000-4-3:2010-Ed.3.2 491
Electromagnetic compatibility (EMC) – Part 4-3: Testing and measurement 492 techniques – Radiated, radio-frequency, electromagnetic field immunity test 493
IEC 61000-4-4:2012-Ed.3.0 494
Electromagnetic compatibility (EMC) – Part 4-4: Testing and measurement 495 techniques – Electrical fast transient/burst immunity test 496
IEC 61000-4-5:2005-Ed.2.0 497
Electromagnetic compatibility (EMC) – Part 4-5: Testing and measurement 498 techniques – Surge immunity test 499
IEC 61000-4-5:2005-Ed.2.0/Cor.1:2009 500
Draft: List of Recognized Standards for Medical Devices | 22
IEC 61000-4-6:2008-Ed.3.0 501
Electromagnetic compatibility (EMC) – Part 4-6: Testing and measurement 502 techniques – Immunity to conducted disturbances, induced by radio-frequency fields 503
IEC 61000-4-8:2009-Ed.2.0 504
Electromagnetic compatibility (EMC) – Part 4-8: Testing and measurement 505 techniques – Power frequency magnetic field immunity test 506
IEC 61000-4-11:2004-Ed.2.0 507
Electromagnetic compatibility (EMC) – Part 4-11: Testing and measurement 508 techniques – Voltage dips, short interruptions and voltage variations immunity tests 509
IEC 80601-2-30:2009-Ed.1.0 510
Medical electrical equipment – Part 2-30: Particular requirements for the basic 511 safety and essential performance of automated non-invasive sphygmomanometers 512
IEC 80601-2-30:2009-Ed.1.0/Cor.1:2010 513
IEC CISPR 11:2010-Ed.5.1 514
Industrial, scientific and medical equipment – Radio-frequency disturbance 515 characteristics – Limits and methods of measurement 516
ISO 14708-1:2014-Ed.2.0 517
Implants for surgery - Active implantable medical devices - Part 1: General 518 requirements for safety, marking and for information to be provided by the 519 manufacturer. 520
General 521
ASTM D4169-16 522
Standard Practice for Performance Testing of Shipping Containers and Systems 523
ASTM F1140-13 524
Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained 525 Packages 526
527
Draft: List of Recognized Standards for Medical Devices | 23
ASTM F1929-98 528
Standard test method for detecting seal leaks in porous medical packaging by dye 529 penetration 530
ASTM F1929-98:2004/(R 2004) 531
ASTM F2096-11 532
Standard Test Method for Detecting Gross Leaks in Packaging by Internal 533 Pressurization (Bubble Test) 534
ASTM F88-15 535
Standard Test Method for Seal Strength of Flexible Barrier Materials 536
IEC 62304:2015-Ed.1.1 537
Medical device software - Software life cycle processes 538
IEC 62366-1:2015-Ed.1.0 539
Medical devices –Part 1: Application of usability engineering to medical devices 540
IEC 62366-1:2015-Ed.1.0/COR 1:2016 541
ISO 10282:2002-Ed.2.0 542
Single-Use Sterile Surgical Rubber Gloves - Specification 543
ISO 11193-1:2008-Ed.2.0 544
Single-use medical examination gloves – Part 1: Specification for gloves made from 545 rubber latex or rubber solution 546
ISO 11193-1:2008-Ed.2.0/Amd.1:2012 547
ISO 11663:2009-Ed.1.0 548
Quality of dialysis fluid for haemodialysis and related therapies 549
ISO 13959:2009-Ed.2.0 550
Water for haemodialysis and related therapies 551
552
Draft: List of Recognized Standards for Medical Devices | 24
ISO 14155:2011-Ed.2.0 553
Clinical investigation of medical devices for human subjects – Good clinical practice 554
ISO 14155:2011-Ed.2.0/Cor.1:2011 555
ISO 14971:2007-Ed.2.0 556
Medical devices – Application of risk management to medical devices 557
ISO 22442-1:2015-Ed.2.0 558
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of 559 risk management 560
ISO 22442-2:2015-Ed.2.0 561
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on 562 sourcing, collection and handling 563
ISO 22442-3:2007-Ed.1.0 564
Medical devices utilizing animal tissues and their derivatives – Part 3: Validation of 565 the elimination and/or inactivation of viruses and transmissible spongiform 566 encephalopathy (TSE) agents 567
ISO 26722:2009-Ed.1.0 568
Water treatment equipment for haemodialysis applications and related therapies 569
SAI AS 2869:2008-Ed.4.0 570
Tampons – Menstrual 571
In Vitro Diagnostic 572
CLSI C46-A2:2009-Ed.2.0 573
Blood gas and pH analysis and related measurements; Approved guideline 574
CLSI EP12-A2:2008-Ed.2.0 575
User protocol for evaluation of qualitative test performance; Approved guideline 576
577
Draft: List of Recognized Standards for Medical Devices | 25
CLSI EP14-A3:2014-Ed.3.0 578
Evaluation of Commutability of Processed Samples; Approved guideline 579
CLSI EP17-A2:2012-Ed.2.0 580
Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; 581 Approved guideline 582
CLSI EP24-A2:-2011-Ed.2.0 583
Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating 584 Characteristic Curves; Approved Guideline – Second Edition 585
CLSI EP25-A:2009-Ed.1.0 586
Evaluation of stability of in vitro diagnostic reagents; Approved guideline 587
(Note: Except: Section 7.1.3) 588
CLSI EP28-A3C:2010-Ed.3.0 589
Defining, establishing, and verifying reference intervals in the clinical laboratory; 590 Approved guideline 591
CLSI EP5-A3:2014-Ed.3.0 592
Evaluation of precision of quantitative measurement procedures; Approved 593 guideline 594
CLSI EP6-A:2003-Ed.1.0 595
Evaluation of the linearity of quantitative measurement procedures: A statistical 596 approach; Approved guideline 597
CLSI EP7-A2:2005-Ed.2.0 598
Interference testing in clinical chemistry; Approved guideline 599
CLSI H15-A3:2000-Ed.3.0 600
Reference and selected procedures for the quantitative determination of 601 hemoglobin in blood; Approved standard 602
603
Draft: List of Recognized Standards for Medical Devices | 26
CLSI H20-A2:2007-Ed.2.0 604
Reference leukocyte (WBC) differential count (proportional) and evaluation of 605 instrumental methods; Approved standard 606
CLSI I/LA18-A2:2001-Ed.2.0 607
Specifications for immunological testing for infectious diseases; Approved guideline 608
CLSI I/LA21-A2:2008-Ed.2.0 609
Clinical evaluation of immunoassays; Approved guideline 610
CLSI MM01-A3:2012-Ed.3.0 611
Molecular Methods for Clinical Genetics and Oncology Testing; Approved Guideline 612
CLSI MM06-A2:2010-Ed.2.0 613
Quantitative Molecular Methods for Infectious Diseases 614
CLSI MM12-A:2006-Ed.1.0 615
Diagnostic nucleic acid microarrays; Approved guideline 616
CLSI MM13-A:2005-Ed.1.0 617
Collection, transport, preparation, and storage of specimens for molecular methods; 618 Approved guideline. Note: Except: Section 6.1.1 619
CLSI MM16-A:2006-Ed.1.0 620
Use of external RNA controls in gene expression assays; Approved guideline 621
CLSI MM17-A:2008-Ed.1.0 622
Verification and validation of multiplex nucleic acid assays; Approved guideline 623
CLSI POCT14-A:2004-Ed.1.0 624
Point-of-care monitoring of anticoagulation therapy; Approved guideline 625
626
Draft: List of Recognized Standards for Medical Devices | 27
IEC 61010-1:2010-Ed.3.0 627
Safety requirements for electrical equipment for measurement, control, and 628 laboratory use – Part 1: General requirements 629
IEC 61010-1:2010-Ed.3.0/Cor.1:2011 630
IEC 61010-1:2010-Ed.3.0/Cor.2:2013 French Only/Version Francaise 631
IEC 61010-2-101:2015-Ed.2.0 632
Safety requirements for electrical equipment for measurement, control, and 633 laboratory use – Part 2-101: Particular requirements for in vitro diagnostic (IVD) 634 medical equipment 635
IEC 61326-1:2012-Ed.2.0 636
Electrical equipment for measurement, control and laboratory use – EMC 637 requirements Part 1: General requirements 638
IEC 61326-2-6:2012-Ed.2.0 639
Electrical equipment for measurement, control and laboratory use – EMC 640 requirements – Part 2-6: Particular requirements – In vitro diagnostic (IVD) medical 641 equipment 642
ISO 15197:2013-Ed.2.0 643
In vitro diagnostic test systems – Requirements for blood-glucose monitoring 644 systems for self-testing in managing diabetes mellitus 645
ISO 23640:2011-Ed.1.0 646
In vitro diagnostic medical devices – Evaluation of stability of in vitro diagnostic 647 reagents 648
Manufacturing 649
ISO 13408-1:2008-Ed.2.0 650
Aseptic processing of health care products - Part 1 : General requirements 651
ISO 13408-2:2003-Ed.1.0 652
Aseptic processing of health care products - Part 2 : Filtration 653
Draft: List of Recognized Standards for Medical Devices | 28
ISO 13408-3:2006-Ed.1.0 654
Aseptic processing of health care products - Part 3 : Lyophilization 655
ISO 13408-4:2005-Ed.1.0 656
Aseptic processing of health care products - Part 4 : Clean-in-place technologies 657
ISO 13408-5:2006-Ed.1.0 658
Aseptic processing of health care products - Part 5 : Sterilization in place 659
ISO 13408-6:2005-Ed.1.0 660
Aseptic processing of health care products - Part 6 : Isolator systems 661
ISO 13408-7:2012-Ed.1.0 662
Aseptic processing of health care products - Part 7 : Alternative processes for 663 medical devices and combination products 664
ISO 14644-1:1999-Ed.1.0 665
Cleanrooms and associated controlled environments - Part 1: Classification of air 666 cleanliness 667
ISO 14644-2:2000-Ed.1.0 668
Cleanrooms and associated controlled environments - Part 2: Specifications for 669 testing and monitoring to prove continued compliance with ISO 14644-1 670
ISO 14644-3:2005-Ed.1.0 671
Cleanrooms and associated controlled environments - Part 3: Test methods 672
ISO 14644-4:2001-Ed.1.0 673
Cleanrooms and associated controlled environments - Part 4: Design, Construction 674 and Start Up 675
ISO 14644-5:2004-Ed.1.0 676
Cleanrooms and associated controlled environments - Part 5: Operations 677
678
Draft: List of Recognized Standards for Medical Devices | 29
ISO 14644-6:2007-Ed.1.0 679
Cleanrooms and associated controlled environments - Part 6: Vocabulary 680
ISO 14644-7:2004-Ed.1.0 681
Cleanrooms and associated controlled environments - Part 7: Separative devices 682 (clean air hoods, glove boxes, isolators and mini-environments) 683
ISO 14644-8:2013-Ed.2.0 684
Cleanrooms and associated controlled environments - Part 8: Classification of air 685 cleanliness by chemical concentration (ACC) 686
ISO 14644-9:2012-Ed.1.0 687
Cleanrooms and associated controlled environments - Part 9: Classification of 688 surface cleanliness by particle concentration 689
ISO 14644-10:2013-Ed.1.0 690
Cleanrooms and associated controlled environments - Part 10: Classification of 691 surface cleanliness by chemical concentration 692
ISO 14698-1:2003-Ed.1.0 693
Cleanrooms and associated controlled environments - Biocontamination control - 694 Part 1: General principles and methods 695
ISO 14698-2:2003-Ed.1.0 696
Cleanrooms and associated controlled environments - Biocontamination control - 697 Part 2: Evaluation and interpretation of biocontamination data 698
Materials 699
ASTM F1088-04a 700
Standard specification for beta-tricalcium phosphate for surgical implantations 701
ASTM F1088-04a:2010/(R 2010)ASTM F1091-08 702
Standard specification for wrought cobalt-20chromium-15tungsten-10nickel alloy 703 surgical fixation wire (UNS R30605) 704
Draft: List of Recognized Standards for Medical Devices | 30
ASTM F1108-04 705
Standard specification for titanium-6aluminum-4vanadium alloy castings for surgical 706 implants (UNS R56406) 707
ASTM F1108-04:2009/(R 2009) 708
ASTM F1295-05 709
Standard specification for wrought titanium-6 aluminum-7 niobium alloy for surgical 710 implant applications (UNS R56700) 711
ASTM F1314-07 712
Standard specification for wrought nitrogen strengthened 22chromium-13nickel-713 5manganese-2.5molybdenum stainless steel alloy bar and wire for surgical implants 714 (UNS S20910) 715
ASTM F1350-08 716
Standard specification for wrought 18chromium-14nickel-2.5molybdenum stainless 717 steel surgical fixation wire (UNS S31673) 718
ASTM F136-12 719
Standard specification for wrought titanium-6aluminum-4vanadium ELI (Extra Low 720 Interstitial) alloy for surgical implant applications (UNS R56401) 721
ASTM F138-08 722
Standard specification for wrought 18chromium-14nickel-2.5molybdenum stainless 723 steel bar and wire for surgical implants (UNS S31673) 724
ASTM F139-08 725
Standard specification for wrought 18chromium-14nickel-2.5molybdenum stainless 726 steel sheet and strip for surgical implants (UNS S31673) 727
ASTM F1472-08 728
Standard specification for wrought titanium-6aluminum-4vanadium alloy for surgical 729 implant applications (UNS R56400) 730
731
Draft: List of Recognized Standards for Medical Devices | 31
ASTM F1537-08 732
Standard specification for wrought cobalt-28 chromium-6 molybdenum alloy for 733 surgical implants (UNS R31537, UNS R31538, and UNS R31539) 734
ASTM F1580-12 735
Standard specification for titanium and titanium-6aluminum-4vanadium alloy 736 powders for coatings of surgical implants 737
ASTM F1586-08 738
Standard specification for wrought nitrogen strengthened 21chromium-10nickel-739 3manganese-2.5molybdenum stainless steel bar for surgical implants (UNS S31675) 740
ASTM F1713-08 741
Standard specification for wrought titanium-13niobium-13zirconium alloy for 742 surgical implant applications (UNS R58130) 743
ASTM F2026-16 744
Standard specification for polyetheretherketone (PEEK) polymers for surgical 745 implant applications 746
ASTM F2565-06 747
Standard guide for extensively irradiation-crosslinked ultra-high molecular weight 748 polyethylene fabricated forms for surgical implant applications 749
ASTM F560-08 750
Standard specification for unalloyed tantalum for surgical implant applications (UNS 751 R05200, UNS R05400) 752
ASTM F562-07 753
Standard specification for wrought 35cobalt-35nickel-20chromium-10molybdenum 754 alloy for surgical implant applications (UNS R30035) 755
ASTM F620-06 756
Standard specification for alpha plus beta titanium alloy forgings for surgical 757 implants 758
759
Draft: List of Recognized Standards for Medical Devices | 32
ASTM F621-08 760
Standard specification for stainless steel forgings for surgical implants 761
ASTM F648-07 762
Standard specification for ultra-high-molecular weight polyethylene powder and 763 fabricated form for surgical implants 764
ASTM F648-07:2007/(e 2007)ASTM F67-06 765
Standard specification for unalloyed titanium for surgical implant applications (UNS 766 R50250, UNS R50400, UNS R50550, UNS R50700) 767
ASTM F688-05 768
Standard specification for wrought cobalt-35 nickel-20 chromium-10 molybdenum 769 alloy plate, sheet, and foil for surgical implants (UNS R30035) 770
ASTM F75-12 771
Standard specification for cobalt-28chromium-6molybdenum alloy castings and 772 casting alloy for surgical implants (UNS R30075) 773
ASTM F799-11 774
Standard specification for cobalt-28chromium-6molybdenum alloy forgings for 775 surgical implants (UNS R31537, R31538, R31539) 776
ASTM F899-12 777
Standard specification for wrought stainless steel for surgical instruments 778
ASTM F90-09 779
Standard specification for wrought cobalt-20chromium-15tungsten-10nickel alloy 780 for surgical implant applications (UNS R30605) 781
ASTM F961-08 782
Standard specification for 35cobalt-35nickel-20chromium-10molybdenum alloy 783 forgings for surgical implants (UNS R30035) 784
785
Draft: List of Recognized Standards for Medical Devices | 33
ISO 3826-1:2003-Ed.1.0 786
Plastic collapsible containers for human blood and blood components – Part 1: 787 Conventional containers 788
ISO 5832-1:2007-Ed.4.0 789
Implants for Surgery – Metallic materials – Part 1: Wrought stainless steel 790
ISO 5832-1:2007-Ed.4.0/Corr1:2008 791
ISO 5832-2:1999-Ed.3.0 792
Implants for surgery – Metallic materials – Part 2: Unalloyed titanium 793
ISO 5832-3:1996-Ed.3.0 794
Implants for surgery – Metallic materials – Part 3: Wrought titanium 6-aluminium 4-795 vanadium alloy 796
ISO 5832-4:1996-Ed.2.0 797
Implants for surgery – Metallic materials – Part 4: Cobalt-chromium-molybdenum 798 casting alloy 799
ISO 5832-5:2005-Ed.3.0 800
Implants for surgery – Metallic materials – Part 5: Wrought cobalt-chromium-801 tungsten-nickel alloy 802
ISO 5832-6:1997-Ed.2.0 803
Implants for surgery – Metallic materials – Part 6: Wrought cobalt-nickel-chromium-804 molybdenum alloy 805
ISO 5832-9:2007-Ed.2.0 806
Implants for surgery – Metallic materials – Part 9: Wrought high nitrogen stainless 807 steel 808
ISO 5832-11:1994-Ed.1.0 809
Implants for surgery – Metallic materials – Part 11: Wrought titanium 6-aluminium 810 7-niobium alloy 811
812
Draft: List of Recognized Standards for Medical Devices | 34
ISO 5832-12:2007-Ed.2.0 813
Implants for surgery – Metallic materials – Part 12: Wrought cobalt-chromium-814 molybdenum alloy 815
ISO 5832-12:2007-Ed.2.0/Cor.1:2008 816
ISO 5834-2:2011-Ed.4.0 817
Implants for surgery – Ultra-high molecular weight polyethylene – Part 2: Moulded 818 forms 819
ISO 6474-1:2010-Ed.1.0 820
Implants for surgery – Ceramic materials – Part 1: Ceramic materials based on high 821 purity alumina 822
ISO 6474-2:2012-Ed.1.0 823
Implants for surgery - Ceramic materials - Part 2: Composite materials based on a 824 highpurity alumina matrix with zirconia reinforcement 825
ISO 7153-1:1991-Ed.2.0 826
Surgical instruments – Metallic materials – Part 1: Stainless steel 827
ISO 7153-1:1991-Ed.2.0/Amd.1:1999 828
ISO 13402:1995-Ed.1.0 829
Surgical and dental hand instruments – Determination of resistance against 830 autoclaving, corrosion and thermal exposure 831
ISO 13782:1996-Ed.1.0 832
Implants for surgery – Metallic materials – Unalloyed tantalum for surgical implant 833 applications 834
Neurology 835
IEC 60601-2-10:2012-Ed.2.0 836
Medical electrical equipment – Part 2-10: Particular requirements for the basic 837 safety and essential performance of nerve and muscle stimulators 838
839
Draft: List of Recognized Standards for Medical Devices | 35
ISO 14708-3:2017-Ed.2.0 840
Implants for Surgery - Active implantable medical devices -- Part 3: Implantable 841 neurostimulators 842
843
ISO 14708-7:2013-Ed.1.0 844
Implants for surgery - Active implantable medical devices - Part 7: Particular 845 requirements for cochlear implant systems 846
Ophthalmology 847
ANSI Z80.7:2002 848
Ophthalmic optics – Intraocular lenses 849
ISO 11979-1:2006-Ed.2.0 850
Ophthalmic implants – Intraocular lenses – Part 1: Vocabulary 851
ISO 11979-2:2014-Ed.2.0 852
Ophthalmic implants -- Intraocular lenses -- Part 2: Optical properties and test 853 methods 854
ISO 11979-3:2006-Ed.2.0 855
Ophthalmic implants – Intraocular lenses – Part 3: Mechanical properties and test 856 methods 857
ISO 11979-4:2008-Ed.2.0 858
Ophthalmic implants - Intraocular lenses - Part 4: Labelling and information 859
ISO 11979-4:2008-Ed.2.0/Amd.1:2012 860
ISO 11979-5:2006-Ed.2.0 861
Ophthalmic implants – Intraocular lenses – Part 5: Biocompatibility 862
ISO 11979-6:2007-Ed.2.0 863
Ophthalmic implants – Intraocular lenses – Part 6: Shelf-life and transport stability 864
865
Draft: List of Recognized Standards for Medical Devices | 36
ISO 11979-7:2006-Ed.2.0 866
Ophthalmic implants – Intraocular lenses – Part 7: Clinical investigations 867
ISO 11979-7:2006-Ed.2.0/Amd.1:2012 868
ISO 11979-8:2017-Ed.3.0 869
Ophthalmic implants – Intraocular lenses – Part 8: Fundamental requirements 870
ISO 11979-10:2018-Ed.2.0 871
Ophthalmic implants - Intraocular lenses - Part 10: Clinical investigations of 872 intraocular lenses for correction of ametropia in phakic eyes 873
ISO TR 22979:2017-Ed.2.0 874
Ophthalmic implants - Intraocular lenses - Guidance on assessment of the need for 875 clinical investigation of intraocular lens design modifications 876
ISO 11980:2009-Ed.2.0 877
Ophthalmic optics – Contact lenses and contact lens care products – Guidance for 878 clinical investigations 879
ISO 15004-2:2007-Ed.1.0 880
Ophthalmic instruments – Fundamental requirements and test methods – Part 2: 881 Light hazard protection 882
ISO 18369-1:2006-Ed.1.0 883
Ophthalmic optics – Contact lenses – Part 1: Vocabulary, classification system and 884 recommendations for labelling specifications 885
ISO 18369-1:2006-Ed.1.0/Amd.1:2009 886
ISO 18369-2:2006-Ed.1.0 887
Ophthalmic optics – Contact lenses – Part 2: Tolerances 888
ISO 18369-3:2006-Ed.1.0 889
Ophthalmic optics – Contact lenses – Part 3: Measurement methods 890
891
Draft: List of Recognized Standards for Medical Devices | 37
ISO 18369-4:2006-Ed.1.0 892
Ophthalmic optics – Contact lenses – Part 4: Physicochemical properties of contact 893 lens materials 894
IEC 80601-2-58:2016-Ed.2.1 895
Medical electrical equipment - Part 2-58: Particular requirements for the basic safety 896 and essential performance of lens removal devices and vitrectomy devices for 897 ophthalmic surgery 898
Orthopaedics 899
ASTM F1044-05 900
Standard test method for shear testing of calcium phosphate coatings and metallic 901 coatings 902
ASTM F1044-05:2005/(R 2017) 903
ASTM F1044-05:2005/(E 2018) 904
ASTM F1089-10 905
Standard test method for corrosion of surgical instruments 906
ASTM F1147-05 907
Standard test method for tension testing of calcium phosphate and metal coatings 908
ASTM F1147-05:2005/(R 2017) 909
ASTM F1147-05:2005/(E 2017) 910
ASTM F1160-14 911
Standard test method for shear and bending fatigue testing of calcium phosphate 912 and metallic medical and composite calcium phosphate/metallic coatings 913
ASTM F1377-13 914
Standard specification for cobalt-28chromium-6molybdenum powder for coating of 915 orthopedic Implants (UNS R30075) 916
917
Draft: List of Recognized Standards for Medical Devices | 38
ASTM F1609-08 918
Standard Specification for calcium phosphate coatings for implantable materials 919
ASTM F1609-08:2008/(R 2014) 920
ASTM F1717-18 921
Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model 922
ASTM F1798-13 923
Standard Test Method for evaluating the static and fatigue properties of 924 interconnection mechanisms and subassemblies used in spinal arthrodesis implants 925
ASTM F1800-12 926
Standard Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total 927 Knee Joint Replacements 928
ASTM F1801-97 929
Standard practice for corrosion fatigue testing of metallic implant materials 930
ASTM F1801-97:1997/(R 2014) 931
ASTM F1829-17 932
Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism 933 in Shear 934
ASTM F1875-98 935
Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip 936 Femoral Head-Bore and Cone Taper Interface 937
ASTM F1875-98:2014/(R 2014) 938
ASTM F2028-14 939
Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or 940 Disassociation 941
ASTM F2077-18 942
Test Methods for Intervertebral Body Fusion Devices 943
Draft: List of Recognized Standards for Medical Devices | 39
ASTM F2267-04 944
Standard Test Method for Measuring Load Induced Subsidence of Intervertebral 945 Body Fusion Device under Static Axial Compression 946
ASTM F2267-04:2004/(R 2018) 947
ASTM F2346-11 948
Standard test methods for static and dynamic characterization of spinal artificial 949 discs 950
ASTM F2582-14 951
Standard Test Method for Impingement of Acetabular Prostheses 952
ASTM F2665-09 953
Standard Specification for Total Ankle Replacement Prosthesis 954
ASTM F2665-09:2014/(R 2014) 955
ASTM F2943-14 956
Standard Guide for Presentation of End User Labeling Information for 957 Musculoskeletal Implants 958
ASTM F3140-17 959
Standard test method for cyclic fatigue testing of metal tibial tray components of 960 unicondylar knee joint replacements 961
ASTM F543-17 962
Standard Specification and Test Methods for Metallic Medical Bone Screws 963
ASTM F746-04 964
Standard test method for pitting or crevice corrosion of metallic surgical implant 965 materials 966
ASTM F746-04:2004/(R 2014) 967
ASTM F86-13 968
Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants 969
970
Draft: List of Recognized Standards for Medical Devices | 40
ASTM F897-02 971
Standard test method for measuring fretting corrosion of osteosynthesis plates and 972 screws 973
ASTM F897-02:2002/(R 2013) 974
ASTM F983-86 975
Standard practice for permanent marking of orthopaedic implant components 976
ASTM F983-86:1986/(R 2013) 977
ISO 5838-1:2013-Ed.3.0 978
Implants for surgery - Metallic skeletal pins and wires Part 1: General requirements 979
ISO 5838-2:1991-Ed.1.0 980
Implants for surgery – Skeletal pins and wires – Part 2: Steinmann skeletal pins – 981 Dimensions 982
ISO 5838-3:1993-Ed.1.0 983
Implants for surgery – Skeletal pins and wires – Part 3: Kirschner skeletal wires 984
ISO 7153-1:1991-Ed.2.0 985
Surgical instruments – Metallic materials – Part 1: Stainless steel 986
ISO 7153-1:1991-Ed.2.0/Amd.1:1999 987
ISO 7206-4:2010-Ed.3.0 988
Implants for surgery partial and total hip joint prostheses – Part 4: Determination of 989 endurance properties and performance of stemmed femoral components 990
ISO 7206-6:2013-Ed.2.0 991
Implants for surgery - Partial and total hip joint prostheses - Part 6: Endurance 992 properties testing and performance requirements of neck region of stemmed 993 femoral components 994
995
Draft: List of Recognized Standards for Medical Devices | 41
ISO 9583:1993-Ed.1.0 996
Implants for surgery – Non-destructive testing – Liquid penetrant inspection of 997 metallic surgical implants 998
ISO 14242-1:2014-Ed.3.0 999
Implants for surgery — Wear of total hip-joint prostheses — Part 1: Loading and 1000 displacement parameters for wear-testing machines and corresponding 1001 environmental conditions for test 1002
ISO 14242-1:2014-Ed.3.0/Amd. 1: 2018 1003
ISO 14242-2:2016-Ed.2.0 1004
Implants for Surgery - Wear of total hip-joint prostheses - Part 2: Methods of 1005 measurement 1006
ISO 14243-1:2009-Ed.2.0 1007
Implants for surgery - Wear of total knee-joint prostheses - Part 1: Loading and 1008 displacement parameters for wear-testing machines with load control and 1009 corresponding environmental conditions for test 1010
ISO 14243-2:2016-Ed.3.0 1011
Implants for surgery - Wear of total knee-joint prostheses - Part 2: Methods of 1012 measurement 1013
ISO 14243-3:2014-Ed.2.0 1014
Implants for surgery — Wear of total knee-joint prostheses — Part 3: Loading and 1015 displacement parameters for wear-testing machines with displacement control and 1016 corresponding environmental conditions for test 1017
ISO 14630:2012-Ed.4.0 1018
Non-active surgical implants - General requirements 1019
Radiology 1020
AIUM/NEMA UD 2:2004 1021
Acoustic output measurement standard for diagnostic ultrasound equipment 1022
AIUM/NEMA UD 2:2004/(R 2009) 1023
Draft: List of Recognized Standards for Medical Devices | 42
AIUM/NEMA UD 3:2004 1024
Standard for real-time display of thermal and mechanical acoustic output indices on 1025 diagnostic ultrasound equipment 1026
IEC 60601-1-3:2013-Ed.2.1 1027
Medical electrical equipment – Part 1-3: General requirements for basic safety and 1028 essential performance – Collateral Standard: Radiation protection in diagnostic X-ray 1029 equipment 1030
IEC 60601-2-28: 2017-Ed.3.0 1031
Medical electrical equipment – Part 2-28: Particular requirements for the basic 1032 safety and essential performance of X-ray tube assemblies for medical diagnosis 1033
IEC 60601-2-37:2015-Ed.2.1 1034
Medical electrical equipment - Part 2-37: Particular requirements for the basic safety 1035 and essential performance of ultrasonic medical diagnostic and monitoring 1036 equipment 1037
IEC 60601-2-43:2017-Ed.2.1 1038
Medical electrical equipment – Part 2-43: Particular requirements for the basic 1039 safety and essential performance of X-ray equipment for interventional procedures 1040
IEC 60601-2-43:2017-Ed.2.1/Amd.1:2017 1041
IEC 60601-2-44:2016-Ed.3.2 1042
Medical electrical equipment - Part 2-44: Particular requirements for the basic safety 1043 and essential performance of X-ray equipment for computed tomography 1044
IEC 60601-2-45:2015-Ed.3.1 1045
Medical electrical equipment – Part 2-45: Particular requirements for the basic 1046 safety and essential performance of mammographic X-ray equipment and 1047 mammographic stereotactic devices 1048
IEC 60601-2-54:2015-Ed.1.0 1049
Medical electrical equipment - Part 2-54: Particular requirements for the basic safety 1050 and essential performance of X-ray equipment for radiography and radioscopy 1051
1052
Draft: List of Recognized Standards for Medical Devices | 43
Sterilization 1053
ASTM F1980-07 1054
Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices 1055
CAN/CSA Z17665-1-09:2009-Ed.1.0 1056
Sterilization of health care products – Moist heat Part 1: Requirements for the 1057 development, validation and routine control of a sterilization process for medical 1058 devices 1059
ISO 11135:2014-Ed.2.0 1060
Sterilization of health care products – Ethylene oxide – Requirements for the 1061 development, validation and routine control of a sterilization process for medical 1062 devices 1063
ISO 11135:2014-Ed.2.0/Amd.1:2018 1064
ISO 11137-1:2006-Ed.1.0 1065
Sterilization of health care products – Radiation – Part 1: Requirement for 1066 development, validation and routine control of a sterilization process for medical 1067 devices 1068
ISO 11137-2:2013-Ed.3.0 1069
Sterilization of health care products – Radiation – Part 2: Establishing the 1070 sterilization dose 1071
ISO 11137-3:2006-Ed.1.0 1072
Sterilization of health care products – Radiation – Part 3: Guidance on dosimetric 1073 aspects 1074
ISO 11138-1:2006-Ed.2.0 1075
Sterilization of health care products – Biological indicators – Part 1: General 1076
ISO 11138-2:2006-Ed.2.0 1077
Sterilization of health care products – Biological indicators – Part 2: Biological 1078 indicators for ethylene oxide sterilization processes 1079
1080
Draft: List of Recognized Standards for Medical Devices | 44
ISO 11138-3:2006-Ed.2.0 1081
Sterilization of health care products – Biological indicators – Part 3: Biological 1082 indicators for moist heat sterilization processes 1083
ISO 11607-1:2006-Ed.1.0 1084
Packaging for terminally sterilized medical devices – Part 1: Requirements for 1085 materials, sterile barrier systems and packaging systems 1086
ISO 11607-2:2006-Ed.1.0 1087
Packaging for terminally sterilized medical devices – Part 2: Validation requirements 1088 for forming, sealing and assembly processes 1089
ISO 11737-1:2006-Ed.2.0 1090
Sterilization of medical devices – Microbiological methods – Part 1: Determination of 1091 population of microorganisms on products 1092
ISO 11737-1:2006-Ed.2.0/Cor.1:2007 1093
ISO 14160:2011-Ed.2.0 1094
Sterilization of health care products - Liquid chemical sterilizing agents for single-use 1095 medical devices utilizing animal tissues and their derivatives - Requirements for 1096 characterization, development, validation and routine control of a sterilization 1097
ISO 14937:2009-Ed.2.0 1098
Sterilization of health care products – General requirements for characterization of a 1099 sterilizing agent and the development, validation and routine control of a 1100 sterilization process for medical devices 1101
ISO 17664:2004-Ed.1.0 1102
Sterilization of medical devices – Information to be provided by the manufacturer 1103 for the processing of resterilizable medical devices 1104
ISO 17665-1:2006-Ed.1.0 1105
Sterilization of health care products – Moist heat Part 1: Requirements for the 1106 development, validation and routine control of a sterilization process for medical 1107 devices 1108
1109