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8/18/2019 Technical File of Wound Drainage System
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Changshu Beyond Medical Device Co., Ltd CE Technical File Part ADocument № BYQA031-00 Revision 1 Issue Date: Mar 20th,2015
Product Master Document 1
CE Technical File of Wound Drainage System File No.: BYQA031-00
Master Document of Product Effective Date: May 20, 2014
:
Prepared by
_______________
_______________
Checked by
_______________
_______________
Approved by
_______________
_______________
Issuing List: Department Holder
1 Management office
2 QM department
3 Production department
4 European Representative
5 TUV SUD
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I. Product General Description
1. Product introduce:
Wound Drainage System is made up of three springs reservoir body , connecting
tube ,barium tube , adapter clamp, trocar with cover. Port A is the entrance jaw, port B is thedrain jaw (Picture below).
2 Use of instruction
I. Drain Placement
Place drains per physics directions and/or hospital procedure,
ensuring that all
perforations are in the wound area. On round drains, indicator
marks aid in drain placement.
II. System Set-up1). Attach the wound drain to the reservoir tube via the “Y”
connector.
2). Insert the free end of the reservoir tube into the reservoir Port A.
III. Activation
a).Close the clamp on the reservoir tube.
b).Place the reservoir in a firm, flat surface.
c).Fully compress the reservoir with one hand.
d).Attach the cap to the Exudate connector B.
e).To activate, release the clamp on the reservoir tube.
IV. To Attach the Pour-safe Exudate Bag
a).Close the clamp on the reservoir tube. Ensure the reservoir is resting on a flat
surface with the connections on top.
b).Remove the bag from the package. Remove the cap from the bag. Remove the cap
from B on the reservoir.
c).Mate the connector on the bag with the connector on the reservoir.
d).Invert and tilt the reservoir such that the contents drain toward B. Compress the
reservoir to empty the contents into the bag.
3. Intend UseThe Closed Wound Drainage System is used for sucking the wasted liquor from the patient’s body
when pressing the wound drainage cavity with the trocar puncturing the patient’s body and
leading the X-ray barium tube.
4. materials
Description Material SupplierRobert Clamp Pom,S761 Changshu QinhuaCo.,LtdConnection tube PVC,202 Shanghia yate industry Development
Co.LtdBarium Tube PVC,202,Stripe:barium sulfate Shanghia yate industry Development
Co.LtdTrocar Stainless Steel 304 Cahngshu Sanxing Spring Factory
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Product Master Document 3
pouch 1059B uncoated Tyvek Alliantz Flexible Packaging,Pte,LtdPlate of Cover - Dseries
Pvc,204 Wuxi Jiahong Plastic Factory
Plate of Cover - D
series
Pvc,204 Wuxi Jiahong Plastic Factory
Entrance Jaw PVC,T-1 Nantong Zhanglian Industry Development
Co.,Ltd
Drain Jaw PVC,T-1 Nantong Zhanglian Industry Development
Co.,Ltd
Film of Cover, printed Pvc,0.35mm Shanghai Baojia Plastic Factory
Bottom Film, printed Pvc,0.35mm Shanghai Baojia Plastic Factory
Transparent Sidewall Pvc,0.25mm Shanghai Baojia Plastic Factory
5. Classification:The X barium tube of wound drainage system inroad the patients body, and remain less than 24 hours,
the trocar was used in 5 minutes. The ways of conformity certification is applying for product CE
certification in accordance with MDD93/42/EEC AS AMENDED BY 2007/47/EC Annex IX., rule 7 of
Annex Ⅸ The classification of the wound drainage system is IIa .
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Product Master Document 4
II. Declaration of Conformity
Manufacturer: ChangshuBeyond Medica l Device Co., l td
No.386 Changkun Road Shajiabang Town215500 Changshu CityPEOPLE’S REPUBLIC OF CHINA
Tel:+86-512-89886868 Fax:+86-512-52939651
European Representative: Shanghai International Holding Corp. GMBH(Europe) Eiffestraβe 80, 20537 Hamburg, Germany.
Tel:+49-40-2513175 Fax:+49-40-255726
Product Name: Closed Wound Drainage System (Wound Drainage reservoir) Model Number: 200ml—800mlUMDNS Code: 16521Classification (MDD, Annex IX): Ⅱa, rule 7Conformity Assessment Route: Annex V. 3
We herewith declare that the above mentioned products meet the transposition into national law, theprovisions of the following EC Council Directives and Standards. All supporting documentations areretained under the promise of the manufacturer.
DIRECTIVES
General applicable directives:
Medical Device Directive: COUNCIL DIRECTIVE 93/42/EEC concerning medical devices (MDD93/42/EEC + 2007 47/EC).
Notified Body: TÜV Product Service GmbH, Ridlerstr. 65, 80339MÜnchen, Germany
Identification number: CE0123(EC) Certificate(s): G2 14 06 87225 003Expire date of the Certificate: 2019-08-28Start of CE Marking: Not Yet
Place, Date of Issue: Changshu, Jiangsu
Signature: _____朱建新 _____________________
Name: ZhujianxinPosition : General Manage
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III. List of Essential Requirement
Number Doc.No Version Document Name
1 ISO13485 2003Quality Management System—Medical Device
Requirement2 ISO10993-1 2009
Biological Evaluation of Medical Device-Part 1:
evaluation and testing
3 ISO10993-5 2009Biological Evaluation of Medical Device-Part 5:
Test for Cytotoxicity : in vitro methods
4 ISO10993-7 2008
Biological evaluation of medical
devices —Part 7:
Ethylene oxide sterilization residual
5 ISO10993-10 2009Biological Evaluation of Medical Device-Part 10:
Test for Irritation and Sterilization
6 ISO14155-1 2003 Medical device clinical investigation
7 MDD93/42/EEC1993.6.14
2007/47/ECMedical Device Directive 2007/47/EC
8 EN ISO14971 2009 Medical Device -Risk Analysis
9 EN980 2008Graphic Symbols for use in the labeling of
medical device
10 EN1041 2008
Terminology, Symbols and Information with
Medical Devices; Information supplied by the
manufacturer with medical devices
11 ISO11137-2 2006Medical Devices Sterilization: Confirmation and
Routine Control of Radio-Sterilization
12ISO 11135-1
2007 Sterilization of medical devices - Validation
and routine control of ethylene oxide
sterilization
13ISO11607-1
2006
Packing Materials for Sterilization of
Wrapped Goods-Part 1:Genenal Requirements and
Requirements for the Validation of Packing for
Terminally Sterilized Device
14 EN ISO 11737-1 2006
Sterilization of Medical
Device-Estimation of the Population of
Micro-organisms on Product Part
1:Requirements
16 EN ISO 11737-2 1996
Medical Device-Estimation of the
Population of Micro-organisms on Product
Part 2:Guidance
17 EN ISO8836:2009 2002Suction Catheters for Use in the Respiratory Tract
Note: Above EC and International Standards are listed in order for corresponding to the 12
items in the Basic Requirement Checklist.The reference records are hold by the supplier. We will provide for you according to the Quality
Assurance Contract if it is necessary.List of the records:
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1. Package Qualification Certificate ;
2. Sterilization Validation Report ;3. Environmental Examination Report ;
4. Clean workshop inspection Report;5. Primary Bacterial Contaminants Test Report ;
6. Verification report of heat-sealing process of leaking test;7 .Inspection regulation of the injection process;8. Inspection regulation of the outer box Protection, storage and transportation;
9. Verification report of heat-sealing process;10. Verification report of heat-sealing of inlet tube ;11. Verification report of heat-sealing of air film ;
12. Confirmation report of the injection process;
13 Experiment report of the aging test;14. Packaging qualification
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III.-2 Essential Requirements checking list of the MDD (07/47/EC) Appl icable
(Y/N)
RequirementStandard
I. GENERAL REQUIREMENTS1. The devices must be designed and manufactured in such a way that, when used under
the conditions and for the purposes intended, they will not compromise the clinicalcondition or the safety of patients, or the safety and health of users or, whereapplicable, other persons, provided that any risks which may be associated with theiruse constitute acceptable risks when weighed against the benefits to the patient andare compatible with a high level of protection of health and safety.
This shall include:- reducing, as far as possible, the risk of use error due
to the ergonomic features of the device and the environment in which the
device is intended to be used (design for patient safety), and
- consideration of the technical knowledge, experience, education andtraining and where applicable the medical and physical conditions ofintended users (design for lay, professional, disabled or other users).
Y
ISO14971:2007
2. The solutions adopted by the manufacturer for the design and construction of thedevices must conform to safety principles, taking account of the generallyacknowledged state of the art. In selecting the most appropriate solutions, themanufacturer must apply the following principles in the following order:
Y
EN ISO8836:200
eliminate or reduce risks as far as possible (inherently safe design and construction), Y EN ISO8836:200
where appropriate take adequate protection measures including alarms if necessary,in relation to risks that cannot be eliminated,
Y EN1401:2008EN980:2008
inform users of the residual risks due to any shortcomings of the protection measures
adopted.
Y EN1401:2008EN980:2008
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(Y/N)
RequirementStandard
• the choice of materials used, particularly as regards toxicity and, where appropriateflammability,
Y ISO10993-1ISO10993-5,-1
• the compatibility between the materials used and biological tissues, cells and bodyfluids, taking account of the intended purpose of the device.
• where appropriate, the results of biophysical or modelling researchwhose validity has been demonstrated beforehand.
Y
N
ISO10993-1ISO10993-5,-1
7.2 The devices must be designed, manufactured and packed in such a way as tominimise the risk posed by contaminants and residues to the persons involved in thetransport, storage and use of the devices and to the patients, taking account of theintended purpose of the product. Particular attention must be paid to the tissuesexposed and the duration and frequency of the exposure.
Y ISO14971:2007
7.3 The devices must be designed and manufactured in such a way that they can be used
safely with the materials, substances and gases with which they enter into contactduring their normal use or during routine procedures; if the devices are intended toadminister medicinal products they must be designed and manufactured in such a wayas to be compatible with the medicinal products concerned according to the provisionsand restrictions governing those products and that their performance is maintained inaccordance with the intended use.
Y ISO14971:200
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(Y/N)
RequirementStandard
7.4 Where a device incorporates, as an integral part, a substance which, if usedseparately, may be considered to be a medicinal product as defined in Article1 of Directive 2001/83/EC and which is liable to act upon the body with actionancillary to that of the device, the quality, safety and usefulness of thesubstance must be verified by analogy with the methods specified in Annex Ito Directive 2001/83/ EC. For the substances referred to in the first paragraph,the notified body shall, having verified the usefulness of the substance as partof the medical device and taking account of the intended purpose of thedevice, seek a scientific opinion from one of the competent authoritiesdesignated by the Member States or the European Medicines Agency (EMEA)acting particularly through its committee in accordance with Regulation (EC)No 726/2004 (1) on the quality and safety of the substance including theclinical benefit/risk profile of the incorporation of the substance into the device.
When issuing its opinion, the competent authority or the EMEA shall take intoaccount the manufacturing process and the data related to the usefulness ofincorporation of the substance into the device as determined by the notifiedbody.
N/A N/A
Where a device incorporates, as an integral part, a human blood derivative,the notified body shall, having verified the usefulness of the substance as partof the medical device and taking into account the intended purpose of thedevice, seek a scientific opinion from the EMEA, acting particularly through itscommittee, on the quality and safety of the substance including the clinicalbenefit/risk profile of the incorporation of the human blood derivative into thedevice. When issuing its opinion, the EMEA shall take into account the
manufacturing process and the data related to the usefulness of incorporationof the substance into the device as determined by the notified body.
N/A N/A
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(Y/N)
RequirementStandard
• risks arising where maintenance or calibration are not possible (as with implants)from ageing of the materials used or loss of accuracy of any measuring or control
mechanism. 在不可能維修或校準的情況下(如植入新物),由於所使用材料的老化或任何測量和控制機制準確度降低所造成的危險。
9.3 Devices must be designed and manufactured in such a way as to minimise the risks offire or explosion during normal use and in single fault condition. Particular attentionmust be paid to devices whose intended use includes exposure to flammable
substances which could cause combustion. 器械的設計和製造必須使其在正常使用和單一故障情況下發生著火和爆炸的危險降低到最小。特別要注意其預定
用途是暴露于易燃或致燃物質中的器械。
N/A N/A
10. Devices with a measuring function
10.1 Devices with a measuring function must be designed and manufactured in such a wayas to provide sufficient accuracy and stability within appropriate limits of accuracy andtaking account of the intended purpose of the device. The limits of accuracy must beindicated by the manufacturer.
N/A N/A
10.2 The measurement, monitoring and display scale must be designed in line withergonomic principles, taking account of the intended purpose of the device.
N/A N/A
10.3 The measurements made by devices with a measuring function must be expressed inlegal units conforming to the provisions of Council Directive 80/181/EEC (OJ No L 39,15. 2. 1980, p. 40. Directive as last amended by Directive 89/617/EEC (OJ No L 357,7. 12. 1989, p. 28)).
N/A N/A
11. Protection against radiation
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(Y/N)
RequirementStandard
11.1
11.1.1General
Devices shall be designed and manufactured such that exposure of patients, usersand other persons to radiation shall be reduced as far as possible compatible with theintended purpose, whilst not restricting the application of appropriate specified levels
for therapeutic and diagnostic purposes. 器械的設計和製造應在兼顧其途的同時
盡可能減少對患者、使用者和其他人員的輻射,同時又不會限制使用規定的
適當劑量進行治療和診斷。
N/A N/A
11.2
11.2.1Intended radiation
Where devices are designed to emit hazardous levels of radiation necessary for aspecific medical purpose the benefit of which is considered to outweigh the risksinherent in the emission, it must be possible for the user to control the emissions. Suchdevices shall be designed and manufactured to ensure reproducibility and tolerance of
relevant variable parameters. 如果爲了特定的治療目的,設計的器械所發射的危險輻射水平,並且該輻射在治療方面的益處超過了他固有的危險,使用者
必須盡可能控制其輻射,這種器械的設計和生産必須確保相關可變參數的重
現性和允許誤差。
N/A
11.2.2 Where devices are intended to emit potentially hazardous, visible and/or invisibleradiation, they must be fitted, where practicable, with visual displays and/or audiblewarnings of such emissions.
N/A
11.3
11.3.1Unintended radiation
Devices shall be designed and manufactured in such a way that exposure of patients,users and other persons to the emission of unintended, stray or scattered radiation is
be reduced as far as possible. 器械的設計和製造應盡可能減少病人、使用者或
其他人員遭受未預期的漫射或散射的輻射。
N/A N/A
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(Y/N)
RequirementStandard
11.4
11.4.1
Instructions
The operating instructions for devices emitting radiation must give detailed informationas to the nature of the emitted radiation, means of protecting the patient and the userand on ways of avoiding misuse and of eliminating the risks inherent in installation.
NA NA
11.5
11.5.1Ionising radiation
Devices intended to emit ionising radiation must be designed and manufactured insuch a way as to ensure that, where practicable, the quantity, geometry and quality ofradiation emitted can be varied and controlled taking into account the intended uses.
N/A N/A
11.5.2 Devices emitting ionising radiation intended for diagnostic radiology shall be designedand manufactured in such a way, as to achieve appropriate image and/or outputquality for the intended medical purpose whilst minimising radiation exposure of thepatient and user.
N/A N/A
11.5.3 Devices emitting ionising radiation intended for therapeutic radiology shall be designedand manufactured in such a way as to enable reliable monitoring and control of thedelivered dose, the beam type and energy and where appropriate the quality of theradiation.
N/A N/A
12. Requirements for medical devices connected to or equipped with an energysource
12.1 Devices incorporating electronic programmable systems must be designed to ensurethe repeatability, reliability and performance of these systems according to theirintended use. In the event of a single fault condition (in the system) appropriate means
should be adopted to eliminate or reduce as far as possible consequent risks. 對於嵌
入了可編程系統的器械,其設計必須要根據預定的用途確保這些系統的重復
性、可靠性和性能。(系統中)出現了單一故障的情況下,應當盡可能地採用適當的方法消除或減少隨之發生的危險。
N/A N/A
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(Y/N)
RequirementStandard
13. Information supplied by the manufacturer
13.1 Each device must be accompanied by the information needed to use itsafely and properly, taking account of the training and knowledge of thepotential users, and to identify the manufacturer
Y EN980:2008EN1041:2008
13.2 Where appropriate, this information should take the form of symbols. Any symbol oridentification colour used must conform to the harmonised standards. In areas forwhich no standards exist, the symbols and colours must be described in thedocumentation supplied with the device.
Y EN980:2008EN1041:2008
13.3 The label must bear the following particulars:
a) the name or trade name and address of the manufacturer. For devicesimported into the Community, in view of their distribution in theCommunity, the label, or the outer packaging, or instructions for use,shall contain in addition the name and address of the authorisedrepresentative where the manufacturer does not have a registeredplace of business in the Community;
Y EN980:2008EN1041:2008
b) the details strictly necessary to identify the device and the contents ofthe packaging especially for the users;
Y EN980:2008EN1041:2008
c) where appropriate, the word "STERILE"; Y EN980:2008EN1041:2008
d) where appropriate, the batch code, preceded by the word "LOT", or the serialnumber;
Y EN980:2008
e) where appropriate, an indication of the date by which the device should be used, insafety, expressed as the year and month; 有效期? Y EN980:2008
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(Y/N)
RequirementStandard
f) where appropriate, an indication that the device is for single use. Amanufacturer's indication of single use must be consihearing aid acrossthe Community;
Y EN980:2008
13.3 g) if the device is custom made, the words "custom made device"; Y EN980:2008
h) if the device is intended for clinical investigations, the words "exclusively for clinicalinvestigations";
Y EN980:2008
i) any special storage and/or handling conditions; Y EN980:2008
j) any special operating instructions; Y EN980:2008
k) any warnings and/or precautions to take; Y EN1401:2008
l) year of manufacture of active devices other than those covered by e). Thisindication may be included in the batch or serial number;
Y EN980:2008
m) where applicable, method of sterilisation. N/A N/A 13.4 If the intended purpose of the device is not obvious to the user, the manufacturer must
clearly state it on the label and in the instructions for use.Y EN1041:2008
13.5 Wherever reasonable and practicable, the devices and detachable components mustbe identified, where appropriate in terms of batches, to allow all appropriate action todetect any potential risk posed by the devices and detachable components.
Y EN1041:2008
13.6 Where appropriate for use, the instructions must contain the following particulars:
a) the details referred to in 13.3, with the exception of d) and e) Y EN1041:2008 b) the performances referred to in section 3 and any undesirable side effects; Y EN1041:2008
c) if the device must be installed with or connected to other medical devices orequipment in order to operate as required for its intended purpose, sufficient details
of its characteristics to identify the correct devices or equipment to use in order toobtain a safe combination;
N/A N/A
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RequirementStandard
k) precautions to be taken in the event of changes in the performance of the device; Y EN1041:2008
l) precautions to be taken as regards exposure, in reasonably foreseeableenvironmental conditions, to magnetic fields, external electrical influences,electrostatic discharge, pressure or variations in pressure, acceleration, thermalignition sources etc.;
Y EN1041:2008
m) adequate information regarding the medicinal product or products which the devicein question is designed to administer, including any limitations in the choice ofsubstances to be delivered;
N/A
n) precautions to be taken against any special, unusual risks related to the disposal ofthe device;
Y EN1041:2008
o) medicinal substances, or human blood derivatives incorporated intothe device as an integral part in accordance with Section 7.4;
N/A
p) degree of accuracy claimed for devices with a measuring function. N/A
q) date of issue or the latest revision of the instructions for use Y EN1041:2008
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IV. Risk Management Report of Wound Drainage System
I. Purpose of Risk Analysis:
The single-use Wound Drainage System manufactured by our Company is recognized by worldwide medicalcircle as a mature product in respects of its design and structure. Its application method is in accordance with
the daily means taken by nursing professionals. Its safety and reliability are ensured. Potential risks still
exist, despite of its small probability. Taking effective preventive measures to prevent any potential safety
hazard and ensure the anticipant usage of products in application is both the goal and the responsibility
of the manufacturer.
1.1 Scope : This document is a RM plan for all the parts of the device, including tubing, reservior kit, trocar etc.
It’s applied for all stage of the life-cycle of the medical devices, including the process of design and
development, production and post-production traceability.
1.2 Members of the Risk Analysis Team
Mr. Peng QA Manager/Management Rep.
Mr. Guansanchao Product EngineerMr. Zhujianxing Technical Dept. Manager ()
II. List of some referenced Standards
The basis of the risk analysis is EN ISO:14971:2007: Medical Device – Applications of Risk Management. The
analysis is performed according to the process shown Figure.
Other information ⑴Feedback information from customer
⑵Samples from other manufacturers
⑶Dialect of newspapers and journalists
⑷Observation and research of market requirement
⑸Information during the development
III. Members of the Risk Analysis TeamTeam leader: organizing and reviewing RM during production life-cycle.
Generally Manager,Plant manager: make suggestions about the measure of risk control and other risk that not bediscovered.Manager of Marketing Department;
Manager of Quality Management Department:Risk management organized and actualized during production and
after marketing.
Responsibilities and authorities:
Title Responsibility Scope
Team leaderProject director, who is responsible for the planning and reviewing of
the procedure of risk analysis
Plant managerEvaluate the probability of generation of hardware failure from the
point of view of technique
QMr Identify the possible defect of manufacture from the point of view oftechnique
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Production
Manager
Evaluate the possible misuse of operator from the point of view of
package, label and transportation
Regulatory
affairs
engineer
Evaluate the possible misuse of operator from the point of view of
Affairs of regulatory and EC harmonized standards applied to the
product
QMEvaluate the possible misuse of operator from the point of view of
clinical information
QAEvaluate the possible misuse of operator from the point of view of
bio-compatibility standards applied to the product
Marketing
Manager
Evaluate the possible misuse of operator from the point of view of
application and affection of adverse events.
IV. Risk management procedure 1. Judgment list of character concerning with risk2. Risk management at the stage of post-product
stage of product
realization
Review action
design input输入阶段 Design input review 输入评审
sample 样品阶段 Sample review 样品评审
polite manufacture试生
产
Design review I 设计评审I
clinic stage临床阶段 Design review II 设计评审II
post- product上市阶段 Annual management review 年度管
理评审
Verification activate
• The verification of the implement of risk control measure will be checked by inspection ofthe risk management files .
• The verification of the effectiveness will be checked by inspection of the result of the riskmanagement.
3. Estimation of the occurrence probability of each hazard
3.1 Quantities and Qualitative Determination of the Features of the Applicant Medical DeviceFollowing question are answered according to Section 3.2 of ISO14971 :2007. To each applicant device, the
features that might cause safety hazards are identified.
3.2 Quantities and Qualitative Determination of the Features of Wound Drainage System
Product Name:Wound Drainage System Device Classification:Ⅱa
Judgment list of character concerning with risk
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Quantities and Qualitative Determination of the Features of
Wound Drainage System
Item Feature that Might Cause Safety
Hazard
Description
1
What is the intended use/intended
purpose and how is the medical
device to be used?
Factors that should be
considered include the intended
user, ergonomic aspects, the
environment in which it is to be
used, by whom it will be installed
and whether the patient can
control or influence the use of
the medical device.
Special attention should be
paid to intended users with special
needs such as handicapped
persons, the elderly and children.
Their special needs might include
assistance by another person to
enable the use of a medical device
life sustaining or life supporting?Is special intervention
necessary in the case of failureof the medical device?
Are there special concerns
about interface design features
that could contribute to
inadvertent use error?
1. Intended use : The Closed Wound Drainage System
is used for sucking the wasted liquor from the patient’s
body when pressing the wound drainage cavity with the
trocar puncturing the patient’s body and leading the
X-ray barium tube.
2.Structure and use direction: Wound drainage system
is made up of trocar, with x-ray barium tube, adapter
clamp, with 3 springs reservoir body. There are two
jaws on the top of the reservoir body, one is entrance
jaw which connect with connecting tube and barium tube,the other is drain jaw with a cap.
3. Warnings/Complications for closed wound drainage
system.
To facilitate remove of the drain, the drain and
tubing portions should not be curled, pinched, over
stretch or sutured ,either internally or externally.
Do not suture the drains. Drains should be placed and
removed carefully by hand only with a slow, steady
pressure. Excessive force may result in breakage.
Drains or tubing should not be handed with any
instruments.Trocars, drains and reservoirs are for single patient use
only and should be discarded after use.
The drain must not be allowed to become occluded nor
the reservoir to completely fill, as all wound drainage
ceases. If occlusion does occur, the drain can be
aspirated by connecting suction to port B or by
applying suction directly to the drain.
All drainage holes must be located within the wound
site and an air tight seal achieved at the wound exit to
maintain vacuum.
Prior to surgery, the patient should be informed of therisk or complications arising from the patient’s degree
of intolerance to any foreign object placed in the body.
Do not re-sterilize.
2
Is the medical device intended to
contact the patient or other
persons? Factors that should be
considered include the nature of
the intended contact, i.e.
surface contact, invasive
contact, and/or implantation and,
for each, the period and frequencyof contact.
Wound drainage system is internal device which is used
to sucking the wasted liquid in patient’s body. And the
process will be operated by the professional nursing
staff. The X-ray barium tube remain in the body less
than 24 hours.
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Item Feature that Might Cause Safety Hazard Description
3
What materials are used to made the device ? Factors
that should be considered include the type of energy
transferred and its control quality, quantity and
duration.
There is vitriol barium mix and
ink with PVC on the side of the
connecting tube. Vitriolic
barium and ink ,being used onstomach clairvoyance, is well
recognized as a safe reagent
clinicly.
4
Is energy delivered to and/or extracted from the
patient? Factors that should be considered include the
type of energy transferred and its control, quality
quantity and duration.
No
5
Are substances delivered to and/or extracted from the
patient? Factors that should be considered include
whether the substance is delivered or extracted,
whether it is a single substance or range ofsubstances, the maximum and minimum transfer rates and
control thereof.
The process will be operated by
the professional doctor
staff.
6
Are biological materials processed by the medical
device for subsequent re-use? Factors that should be
considered include the type of process and
substance(s).
The wasted liquid sucked from
patient should be disposed by
doctor, and do not make
pollution .
7
Is the medical device supplied sterile or intended to
be sterilized by the user, or are other
microbiological controls applicable? Factors that
should be considered include whether the medical
device is intended for single-use or to be re-usable,
and also any packaging, the shelf-life and any
limitation on the number of re-use cycles or type of
sterilization process to be used.
The product is provided to
the customer in sterile
situation.. The product is
single-packed and its
expiration date is five years.
And the product is also
single-used
8
Is the medical device intended to modify the patient
environment? Factors that should be considered
include temperature, humidity, atmospheric gas
composition, pressure and light.
According to doctor’s
Prescription, suck the liquid
on the partial of the patient,
so relax the patient. Thetemperature can be
ameliorated.
9
Are measurements taken? Factors that should be
considered include the variables measured and the
accuracy and the precision of the measurement results.
There is a scale on the side of
the reservoir body, it can
measure the quantity of the
wasted liquid.
10
Is the medical device interpretative? Factors that
should be considered include whether conclusions are
presented by the medical device from input or acquired
data, the algorithms used and confidence limits.
No
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Item Feature that Might Cause Safety Hazard Description
11
Factors that should be considered include identifying any
medicines or other medical technologies which can be involved
and the potential problems associated with such interactions,
as well as patient compliance with the therapy.
No
12
Are there unwanted outputs of energy or substances?
Energy-related factors that should be considered include noise
and vibration, heat, radiation(including ionizing,
non-ionizing and ultraviolet/visible/infrared
radiation),contact temperatures, leakage currents and
electric and/or magnetic fields.
Substance-related factors that should be considered include
discharge of chemicals, waste products and body fluids.
The connecting tube only
insert the drainage
partial, and controlled
the quantity of the
liquid.
13
Does the medical device influence the environment?
Factors that should be considered include the effects on power
and cooling supplies, emission of toxic materials and the
generation of electromagnetic interference
The device transportationand storage should be in
the condition of less than
40℃, humidity less
than 80%.
The device used in the
operating room.
14
Are there essential consumables or accessories associated with
the medical device?
Factors that should be considered include specifications
For such consumables or accessories and any restrictions placed uponusers in their selection of these.
No
15
Is maintenance and /or calibration necessary?
Factors that should be considered include whether maintenance
and/or calibration are to be carried out by the operator or user
or by a specialist, are special substances or equipment
necessary for proper maintenance and /or calibration?
No
16
Does the medical device contain software?
Factors that should be considered include whether software is intended
to be installed, verified, modified or Exchanged by the user and /or
operator.
No
17
Does the medical device have a restricted shelf life? Factors
that should be considered include labeling or indicators and
the disposal of such medical devices.
The expiration date is five
years, which will be
labeled on the package. It
can be handled according
to the law and the
regulation of the country if
it had exceeded the
expiration date.
Item Feature that Might Cause Safety Hazard Description
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18
Are there any delayed and/or long-term use effects? Factors
that should be considered include ergonomic and cumulative
effects.
No
19
To what mechanical forces will the medical device be
subjected?
Factors that should be considered include whether the Forces to
which the medical device will be subjected are under the
control of the user or controlled by interaction Which other
persons
The device depend on
the compression spring
come into suppressing and
sucking the wasted liquid.
20
What determines the lifetime of the medical device?
Factors that should be considered Include ageing and battery
depletion.
The aging of the raw
material has determined
the product’s life
expectancy.
21 Is the medical device intended for Single use? Sign use only.
22
Is safe decommissioning or disposal Of the medical devicenecessary? Factors that should be considered include the waste
products that are Generated during the disposal of the medical
device itself, for example does it contain toxic or hazardous
Material, or is the material recyclable?
The discarded deviceshould be handled
according to the laws or
regulations of that country.
23
Does installation or use of the medical device require special
training? Factors that should be considered include
commissioning and handing Over to the end user and whether it
is Likely/possible that installation can Be carried out by people
without the Necessary skills.
The direction of use is
provided in the packing
label. The user should be
professional doctor or
nursing stuff.
24Will new manufacturing processes need to be established orintroduced. The introduction of new hazard(s)(e.g.new
technology, new scale of production).
No
25
Is successful application of the medical device
critically dependent on human factors such as user
interface? Device control, symbols used ,Ergonomic
features, physical design and layout, hierarchy of
operation, menus for software driven devices,
visibility of warnings, audibility of alarms,
standardized colour coding. these Considerations
include, but are not limited to, the following. Does
the medical device have connecting Parts or
accessories? Differentiation, similarity to other
products’ connections, connection force, feedback on
connection integrity, and over-and under-tightening,
Does the medical device have a control interface?
Visibility, Direction of activation or change, and
Whether the controls are continuous or discrete, and
the reversibility of settings or actions. Does the
medical device display information?Is the medical device controlled by a menu?
The material of the
product selection should
suit for the steady of
production process.
The device controlled by
professional doctor and by
the direction of use.
Entrance Jaw and connecting
tube connecting will fall
of, There are clear method ofuse on the manual
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Item Feature that Might Cause Safety Hazard Description
26
Is the medical device intended to be mobile or portable? Factors thatshould be considered are the necessary grips, handles, wheels,
brakes, mechanical stability and durability.
The hanger of the wounddrainage system should be set
firm enough to bear the weight
of the wasted liquid.
27
Does the device should be cleaned and steriled before use.
How frequency does the clean and sterile do ?
The product is sign use
only, it does need to clean
and sterile before use.
Ensure the endotoxin are
not overweight
prepared: Terry Tan reviewed: Zhu jianxin
4. Definition criterial
4.1 criteria of severity for harm No. Category Description Examples
1 Negligible No hazard occurs or almost
noSkin irritation
2 Marginal Hazard occurs possiblyCoronary arterial spasm
动脉痉挛
3 CriticalPotential of death or serious
injury
Acute myocardial
infarction心肌梗死
4 CatastrophicDeath or injure occurs
possiblyDeath
4.2 Criteria of the probability for harm
No. Class Description Example
1 Incredible Never occurred (1) None
4.3 Criteria for risk acceptability– When Severity =4,CAPA should been taken 。
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– When Severity=3, probability ≥5, CAPA should been taken– When Severity=2, probability =6, CAPA should been taken– For the residual risk, CAPA should been taken for the top 20﹪risk .
Severity
Likelihood 1 Negligible 2 Marginal 3 Critical 4 catastrophic
6 Frequent * N/ACC N/ACC N/ACC
5 Probable * * N/ACC N/ACC
4 Occasional * * * N/ACC
3 Remote ACC * * *
2 Unlikely ACC ACC * *
1 Incredible ACC ACC ACC ACC
N/ACC = not acceptable
ACC = acceptable
5. Risk analysis report
Wound drainage system potential hazard
1 Potential hazards are listed below based on the qualitative analysis on the product features
according to ISO14971 Annex D:
Product Name:Wound Drainage System Device Classification:Ⅱa
Type of Hazard Potential HazardYes No Nor
mal Failure Risk
Factor
If yes (known, foreseen andnot confirmed), describe potential hazard
1.Energy Hazard 1.Pressure (thecontainer breaksand leaks)
√ √ 2The container is likelyto break or leak if the
up cover or bottomcover hit sealingunsteady.
2.Biological hazard
Bio
Contamination
Bio
un-compatibility
Across infect
√
√
√
√
√
3
1.After sterilization, the
SAL for products reach
10-6
to ensure the
thorough sterilization
and reduce the hazard
and risk to acceptable
extent.
2.The material of the barium should be
selected strictly.
3.All parts of the device
are sign use only.
4.Hazard in
Applications of the
device
Improper
Package(the
pollution or
metamorphism of
the medical
equipments)
√
√
√
√
√
√
2
1、The discarded products and the
discharged liquid waste
should be handledaccording to the lawsand regulations of that
country. 2、Leakness
Inspection.
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5.Hazards due to
Function Failure,
improper
Maintenance or
Aging
1、Lack of Proper
Regulation on
End of erviceLife
√ √
3 The device has
exceeds the actual
expiration date and
that lead to the
aging of the product.So the product cannot
be used regularly.
prepared:Terry Tan reviewed: Zhujianxin
2 other risk
Product Name:Wound Drainage System Device Classification:Ⅱa
Source of Hazard PotentialHazard
Yes No Normal
Failure
RiskFactor
If yes (known, foreseenand not confirmed),
describe potential hazard
Batch inconsistency Different batch
of manufacture√ √
1
Intended usage
failure. Write clear
batch record, make
sure it is traceable.
Common interfering
factor
Different
Environment √ √ 1 Make sure the
environment of the
transportation and
storage are acceptable.
Carry-over effects√ √ 1
Finished good
inspection insure the
product clean and
qualify.
Sample
identification errors√ √
2
Sample validation
Stability problem Package damaged
√ √
2
The proficiency of
workers’ operation
prepared:Terry Tan reviewed: Zhu jianxin
3 Analysis evaluation report
3.1. Risk evaluation:according to criteria
Severity Probability
1=negligible 1=incredible
2=marginal 2=unlikely
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3=critical 3=remote
4=catastrophic 4=occasional
5=probable
6=frequent
Severity
probability
1 2 3 4
6 * N/ACC N/ACC N/ACC
5 * * N/ACC N/ACC
4 * * * N/ACC
3 ACC * * *
2 ACC ACC * *
1 ACC ACC ACC ACC
3 2 Risk estimation and risk evaluation
Risk
estimationEnergyHazards
harms Potential causes
S P
Riskevaluation
R1: Trocar can not punch through the patient
body.
R1.1 residua on
trocar3 4 N/ACC
R1.2 suction tubeblock up
3 5 N/ACC
R1.3 suction failure3 5 N/ACC
Performance
Trocar
sharpness
failure
Barium tube
Rerservoir kit
leakR2: separation of tubing in body
3 3 Risk control of R1
. R1 Hazard Trocar failure, leak
sk evaluation Can cause Acute myocardial infarction, dead. S 3, P 5, N/ACC
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tion selectSafe design and
protective measure
controllable?Yes
unter measures
1. Sharpness ensurance 100% test.
2. risidua inspection
3. Leak test
erification Varification report
esidual risk S 3, P 2, ACC
sk/benefit
alysis
benefit outweighs the risk
plaining The Probability of tubing broke and lefe in patient body and cause patient decease tounlikely level. As the reservoir kit system have been broadly used worldwide for manyyears, and the benefit of reservoir kit is obvious weighting profit against potentialhazards
ew risk No
3.4 Evaluating effectiveness of risk control measure
DHR review.
4.Risk and profit analysisFrom results we got upwards, we know that : 1. the risk management plan has been appropriately implemented;2.by the measures taken all risks are reduced to acceptable level nowadays.3. the overall residual risk is acceptable;
5. SummaryThe main material of the disposable sterile Wound drainage system is trocar, barium tube, connecting tube, the
reservoir body.. The microbes infection and sensitization have been effectively prevented through the control over theincoming examination of raw material and auxiliary material, environment control, the manufacturing process, the finalinspection and sterilization validation. The biocompatibility test and clinical data prove that the products would notcause the harmful stimulation, sensitization and other harmful effects to the mucous membrane of the skin and would
not separate out venomous substance. Meanwhile, every link of the relevant process shall be under controlled status toensure the microbes pollution to the least level, within acceptable scope and in conformance with the requirements of93/42/EEC as amended by 2007/47/EC. All the risk s are describes, evaluated and proved to be within acceptablescope and will not cause the human body to feel unwell, and even death.
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V. Clinical Data
1. Product Profile:
1.1 Wound drainage system, which is used for sucking the wasted liquor
from the patient’s body when pressing the wound drainage cavity with the trocar puncturing the patient’s body andleading the X-ray barium tube. And the product is mainly made of non-toxic PVC and a trocar, so it do no harm to thepatients, nursing staff as well as other relevant or irrelevant people.
1.2 Wound drainage suction tube is widely used in surgical field for suction of waste fluids from a surgical wound.It is mainly made of medical grade PVC and is inert to the body fluid and blood, so it is safe and effective for itsintended use. Beyond’s manufacturing facility of the suction connecting tube has years of experience of making plasticmedical device for single use, and is running under the certified quality management system of ISO13485,as well asCE.
2. Assessment Of Risks And Benefits:
We have managed the risks of the product in four periods: before the designing and developing period, in the stage
of affirmance of the product’s designing and developing, in the production procedure as well as after the collection ofthe feedbacks. And we also adopted a series of efficient controlling measurement to deal with the possible dangerswhich may occur in every stage. Thus, we have minimized the risks to the acceptable range and we assure that thedangers caused by the left risks are much more less than the benefits the product bring to the patients.
3. Product Literature Summarize
The design and the structure of the product have been proved internationally. The steady quality of the productavoids us from any reports about unpleasant medical accidents caused by our equipments during the production andclinical use for these years.
4. The general information of the clinical use:
The wound drainage system manufactured in our company have been sold to overseas market including theOccident and other Asian countries. Since the start of production, the output value has been increasing year by year.Our company has set up perfect after sale services. And according to the statistics, we had sold out more than tenthousand wound drainage system by now. we haven’t received any complaints about unpleasant medical accidents orquality problems caused by our equipment during the clinical use up to now. The result shows that our product is eithersafe or reliable and the product’s quality is excellent.
5 Target market and sales volumeMajor target market is North America, but we are developing Europe market. The sales volume may exceed 1 millionpcs within one or two years.
6.Product safety and effectiveness reviewThis device is made of medical grade PVC, and stainless steel, so from the past experience of other
device, the device is safe.The sterile products are packaged with individual packaging, and sterilized by EtO at SAL 10-6 , thesterility is assured.There are warning words and precautions during condition of use indicated on the label, therefore, toavoid the adverse effect or reduce it to a minimum level.
7.The wound drainage suction reservoir manufactured by our company has been proven to be safe,effective, applicable and be capable of meeting the demands of customer through clinical application inhospital. The results of application are :7.1 Safety: No adverse events or malfunction has been reported.7.2 Effectiveness:a) no adverse event happened, the function of the product, such as suction is effective during the condition ofuse;b) can meet the requirements of clinical application.7.4.3 Applicationa) convenient and applicable for vacuum suctuion;b) no other harm to patients;7.4.4 Othersa) the package is integral;b) the labeling is legible and clear;
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c) instruction for use is clear and fulfills regulation requirements.
8. The effect after use and feedback from our customersWe operated under the operational procedure during production of the product, and conduct quality management
according to ISO13485. For each stage of all processes, i.e. material incoming, assembling, packaging and labeling,sterilization and final release, specifies relevant inspection and control procedures. And it can avoid some adverse
effects to users from unstable factors; therefore, our product can meet the requirements of customers. By application ofpassed years, it has proven that our product is stable in quality, safe and reliable. The feedback fromour customers isgood; the adverse effect of our product is acceptable under normal condition of use.
VI. Label
1.0 Purpose
To give directions for proper operations with the products according to the requirement of MDD.
2.0 Scope of Application:
Applicable to the control procedures for utilization of disposable sterile product label.
3.0 Responsibility
3.1 Technical Development Department is responsible for preparing literal description on the labels.
3.2 The General Manager is responsible for validating the accuracy of the description on the labels.
4.0 Procedures
4.1 Technical Development Department is responsible for preparing specific items on the label, including:
4.1.1 Names and addresses of the Manufacturer, Importer and European Representative
4.1.2 Product name, trade mark, model, size, quantity and bar code;
4.1.3 literal indication of sterilization: “Sterilization” and ETO Sterilization symbols;
4.1.4 Lot number and identification marks:
a) Lot number mark:
LOT
b) The lot number is a 8-digit number, the former 4 for particular year and the latter 4 for serial number.
c) For example: LOT20020001
representing that it is manufactured in the first batch in 2002.
d) The size and location of the lot number and the identification marks are not specified.
4.1.5 “USE BY” indication for service life;
a) “USE BY” mark
STERILE EO
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b) The service life consists of 6 digits, the former 4 for the particular year and the latter 2 for the particular month, with asymbol ”-” going between them.
c) This identification mark indicates the last effective year in the service life of the disposable product
d) For example: 2002-06
representing that the product shall be used before June 2002.
4.1.6 Date of manufacturing
a) Identification mark
b) The date of manufacturing consists of 8 digits, the former 4 for the productive year and the latter 4 for the month anddate respectively;
c) For example: 20050608
representing the date of manufacturing is April 8, 2000;
d) The sizes and locations of the marks and the identifications are not specified.
4.1.7 Identification for disposable product “Disposable (single-use)” and the identification mark
h=1.16a
This mark represents “Disposable (single-use)”
4.1.8 The mark of “SEE INSTRUCTIONS FOR USE” and its application
a) Identification mark:
b) Note:
4.1.9 There shall be a CE mark and code of Proclamation Organization after the product is CE certified.
i. Icon:
0123
b) The vertical height of the icon shall be no less than 5mm and is usually placed at the lower right corner. CE markshall be clear and easy to be caught in eyes.
4.1.10 Symbol for “CATALOGUE NUMBER”
REF ABC123
NO Stipulation for their size and location, to make it if applicable.
4.2 Technical Development Department submits the prepared label description to the General Manager for approval.According to the requirement of MDD, label language must be translated into target market-specific language.
4.3 The reviewed documents for label descriptions are filed together with technical documents.
4.4 The distribution, management and alteration of the label descriptions (technical documents) are in accordance withthe regulations on procedure documents such as “Controlling Procedures for Documents and Data” and “ControllingProcedures for Quality System Document”.
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5.0 Relevant Documents
“Controlling Procedures for Documents and Data”
Section 13 of Annex I, Annex VII (MDD93/42/EEC AS AMENDED BY 2007/47/EC)
EN980: Graphic Symbols for Use in Labeling of Medical Devices
Labels for external package, middle package and inner package of the product are attached.
VIII. Product Quality Assurance:Performance and steadity evaluation
8.1 Product Performance Test Report
Refer to product performance test at inspection record list XSQA008 current version.
8.2 Biocompatibility Test Report (The Tests for irritation and sensitization)
8.2.1 GeneralAccording to the Council Directive 93/42 EEC and ISO 10993-10, The Tests for irritation and
sensitization have been performed to this device, so as to obtain evidence that the product issafe for its intended use.
8.2.2 Tested by :Cardinal Health
8.2.3 AppendixAppendix I Test report of the Wound Drainage Suction ReservoirAppendix II Retention sample test report
8.3 Aging Test
8.3.1 General
According to the ISO 11137: 2006,The aging test for five years has been performed so as to
obtain evidence that the product is credible for its intended use in it’s expiration date.
8.3.2 Tested by :Appendix Speed aging test report
8.3.3 The test results showed,the device valid for 5 years shelflife
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IX. Production Process Description
9.1 Production Process
9.1.1 Process flow chart refer to XSPR-SS007, Rev 00 , see attachment 2,9.1.2 Process validation report below list
Process Validation Protocol/Report List
No Document No.
1 FS/QR-7.6-02-01
2 FS/QR-7.6-02-02
3 FS/QR-7.6-02-03
4 FS/QR-7.6-03-01
5 FS/QR-7.6-03-02
6 FS/QR-7.6-04-01
7 FS/QR-7.6-04-02
8 FS/QR-7.6-05-01
9 FS/QR-7.6-05-02
10 FS/QR-7.6-06-01
11 FS/QR-7.6-06-02
12 FS/QR-7.6-07-01
13 FS/QR-7.6-07-02
14 FS/QR-7.6-08-01
15 FS/QR-7.6-08-02
16 FS/QR-7.6-09-01
17 FS/QR-7.6-09-02
18 FS/QR-7.6-10-01
19 FS/QR-7.6-10-02
20 FS/QR-7.6-11-01
21 FS/QR-7.6-11-02
Components Name
IQ BeyondZ001
IQ BeyondZ002
IQ BeyondZ003
OQ-Plate of Cover OQ
PQ-Plate of Cover PQ
OQ-Plate of Bottom OQ
PQ-Plate of Bottom PQ
OQ- Drain Jaws OQPQ- Drain Jaws PQ
OQ- Entrance Jaws OQ
PQ- Entrance Jaws PQ
OQ- Bed Sheet OQ
PQ- Bed Sheet PQ
OQ- Robert Clamp OQ
PQ- Robert Clamp PQ
OQ- Barium Tube OQ
PQ- Barium Tube PQ
OQ- Connection Tube OQPQ- Connection Tube PQ
OQ- Cover for Trocar OQ
PQ- Cover for Trocar PQ
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Changshu Beyond Medical Device Co., Ltd CE Technical File Part
ADocument № BYQA031-00 Revision 1 Issue Date: Mar 20th,2015
9.1.3 Refer to Device Master Records XSQA013.
9.2 Raw materials and packaging materials
9.2.1 Refer to XSQA-038 Rev 00.9.3 Manufacturing Environment
9.3.1This device should be manufactured in class 100,000 clean room.9.3.2 Monitoring scheme of manufacturing environment.
To be decided by the manufacturing facility per Changsu Beyond XSPR-SS003/004.9.3.3 Bioburden of the product.
Clear room bioburden test will perform by Cardinal Health quarterly and test report willkept by Cardinal Healthshanghai.
9.4 Labeling Control
Refer to Changsu Beyond procedure XSLO-PP002, Rev 01.
9.5 Traceability
Refer to Changsu Beyond procedure XSPR-PP001, Rev 01.
9.6 Release
Refer to Changsu Beyond Procedure XSQA-PP007,Rev 01.
X. Process Validation
10.1 Environmental Validation
Refer to the: Waiting for report TBD
10.2 Process Validation
Refer to the extension validation and first article inspection report. (at)
10.3 Packaging Integrity Validation
Refer to the
10.4 Sterilization Validation
Refer to Changsu Beyond Procedure XSQA031-01,Rev A-00