Wound Drainage System CE Technical File

Changshu Beyond Medical Device Co.
, Ltd
Document BYQA031-00
Revision
CE Technical File of Wound Drainage System

Master Document of Product
File No.: BYQA031-00

Effective Date: May 20, 2014
Checked by
Approved by
_______________
_______________
_______________
_______________
_______________
_______________
Prepared by
:
Issuing List:
Department
Management office
QM department
Production department
European Representative
TUV SUD
Product Master Document
Part A
CE Technical File
Issue Date: Mar 20th,2015
Holder
Changshu Beyond Medical Device Co., Ltd

Document BYQA031-00
Revision
CE Technical File
Part A
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 the
drain 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-up

1). 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 Use
The Closed Wound Drainage System is used for sucking the wasted liquor from the patients body
when pressing the wound drainage cavity with the trocar puncturing the patients body and
leading the X-ray barium tube.
4. materials
Description
Robert Clamp
Connection tube
Material
Pom,S761
PVC,202
Barium Tube
PVC,202,Stripe:barium sulfate
Trocar
Stainless Steel 304
Supplier
Changshu QinhuaCo.,Ltd
Shanghia yate industry Development
Co.Ltd
Shanghia yate industry Development
Co.Ltd
Cahngshu Sanxing Spring Factory
2

Document BYQA031-00
pouch
Plate of Cover - D
series
Plate of Cover - D
Revision
CE Technical File
Part A
1059B uncoated Tyvek

Pvc,204
Alliantz Flexible Packaging,Pte,Ltd

Wuxi Jiahong Plastic Factory
Pvc,204
Wuxi Jiahong Plastic Factory
PVC,T-1
Nantong Zhanglian Industry Development
series
Entrance Jaw
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
Transparent Sidewall
Pvc,0.25mm
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 The classification of the wound drainage system is IIa .

Document BYQA031-00
Revision
CE Technical File
Part A
II.
Declaration of Conformity
Manufacturer:
ChangshuBeyond Medical Device Co.,ltd

No.386 Changkun Road Shajiabang Town
215500 Changshu City
PEOPLES REPUBLIC OF CHINA
Tel:+86-512-89886868 Fax:+86-512-52939651
European Representative: Shanghai International Holding Corp. GMBHEurope

Eiffestrae 80, 20537 Hamburg, Germany.
Tel:+49-40-2513175 Fax:+49-40-255726
Product Name: Closed Wound Drainage System (Wound Drainage reservoir)
Model Number: 200ml800ml
UMDNS Code: 16521
Classification (MDD, Annex IX): a, rule 7
Conformity Assessment Route: Annex V. 3
We herewith declare that the above mentioned products meet the transposition into national law, the
provisions of the following EC Council Directives and Standards. All supporting documentations are
retained under the promise of the manufacturer.
DIRECTIVES
General applicable directives:
Medical Device Directive: COUNCIL DIRECTIVE 93/42/EEC concerning medical devices (MDD
93/42/EEC + 2007 47/EC).
Notified Body:
Identification number:
(EC) Certificate(s):
Expire date of the Certificate:
Start of CE Marking:
TV Product Service GmbH, Ridlerstr. 65, 80339

Mnchen, Germany
CE0123
G2 14 06 87225 003
2019-08-28
Not Yet
Place, Date of Issue:
Changshu, Jiangsu
Signature:
Name:
Position :
__________________________
Zhujianxin
General Manage

Document BYQA031-00
Revision
CE Technical File
Part A
III. List of Essential Requirement

Number
Doc.No
Version
ISO13485
ISO10993-1
2009
ISO10993-5
2009
ISO10993-7
2008
ISO10993-10
2009
ISO14155-1
2003
MDD93/42/EEC
EN ISO14971
2009
EN980
2008
10
EN1041
2008
11
ISO11137-2
2006
12
13
ISO 11135-1
ISO11607-1
2003
1993.6.14
2007/47/EC
2007
2006
14
EN ISO 11737-1
2006
16
EN ISO 11737-2
1996
17
EN ISO8836:2009
2002
Document Name
Quality Management SystemMedical Device
Requirement
Biological Evaluation of Medical Device-Part 1:
evaluation and testing
Test for Cytotoxicity : in vitro methods
Biological evaluation of medical
devices Part 7:
Ethylene oxide sterilization residual
Test for Irritation and Sterilization
Medical device clinical investigation
Medical Device Directive 2007/47/EC
Medical Device -Risk Analysis
Graphic Symbols for use in the labeling of
medical device
Terminology, Symbols and Information with
Medical Devices; Information supplied by the
manufacturer with medical devices
Medical Devices Sterilization: Confirmation and
Routine Control of Radio-Sterilization
Sterilization of medical devices - Validation
and routine control of ethylene oxide
sterilization
Packing Materials for Sterilization of
Wrapped Goods-Part 1:Genenal Requirements and
Requirements for the Validation of Packing for
Terminally Sterilized Device
Sterilization of Medical
Device-Estimation of the Population of
Micro-organisms on Product Part
1:Requirements
Medical Device-Estimation of the
Population of Micro-organisms on Product
Part 2:Guidance
Suction 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
Assurance Contract if it is necessary.
List of the records:
according to the Quality

Document BYQA031-00
Revision
CE Technical File
Part A
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

Document BYQA031-00
III.-2
Revision
CE Technical File
Part A
Essential Requirements checking list of the MDD (07/47/EC)
Applicable
(Y/N)
I.
GENERAL REQUIREMENTS
1.
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 clinical Y
condition or the safety of patients, or the safety and health of users or, where
applicable, other persons, provided that any risks which may be associated with their
use constitute acceptable risks when weighed against the benefits to the patient and
are compatible with a high level of protection of health and safety.
Requirements
Standard
ISO14971:2007
Conformity of
Manufacturer
Responsible/
Justification
Risk management
report
Technical
engineer team
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 and

training and where applicable the medical and physical conditions of
intended users (design for lay, professional, disabled or other users).
2.
The solutions adopted by the manufacturer for the design and construction of the Y
devices must conform to safety principles, taking account of the generally
acknowledged state of the art. In selecting the most appropriate solutions, the
manufacturer must apply the following principles in the following order:
EN ISO8836:2009
eliminate or reduce risks as far as possible (inherently safe design and construction),
EN ISO8836:2009
where appropriate take adequate protection measures including alarms if necessary,

in relation to risks that cannot be eliminated,
EN1401:2008
EN980:2008
inform users of the residual risks due to any shortcomings of the protection measures
adopted.
EN1401:2008
EN980:2008
Performance test
Quality dpt
Performance
Quality dpt
Label requirement Label
caution
and instruction
for use
Label requirement Label
caution
and instruction
for use

Document BYQA031-00
III.-2
Revision
CE Technical File
Part A
Applicable
(Y/N)
3.
The devices must achieve the performances intended by the manufacturer and be Y
designed, manufactured and packaged in such a way that they are suitable for one or
more of the functions referred to in Article 1 (2) (a), as specified by the manufacturer.
Requirements
Standard
EN868-1
ISO11137EN1
733
Conformity of
Manufacturer
Qualification
Certificate
(CE-LJ09)
Preclinical Study
(CE-LJ-06)
Responsible/
Justification
Quality dpt.
4.
The characteristics and performances referred to in sections 1, 2 and 3 must not be Y

adversely affected to such a degree that the clinical condition and safety of the patients
and, where applicable, of other persons are compromised during the lifetime of the
device as indicated by the manufacturer, when the device is subjected to the stresses
which can occur during normal conditions of use.
Risk management Technical

report;
department,.
ISO11137
Preclinical Study quality
EN ISO8836:2009
department f
(Beyond-TF-01)
5.
The devices must be designed, manufactured and packed in such a way that their Y
characteristics and performances during their intended use will not be adversely
affected during transport and storage taking account of the instructions and information
provided by the manufacturer.
EN868-1
EN980
EN1041
Package
Qualification
Certificate
(CE-LJ09)
Label (CE-LJ-10
6.
Any undesirable side effects must constitute an acceptable risk when weighed against Y
the performances intended.
ISO14971:2007
ISO14155
Risk management Technical

report;
department,.
quality
Clinical
department
investigation
ISO10993-1
ISO10993-5,-10
Biocompatibility
test report
ISO14971:2007;
6a. Demonstration of conformity with the essential requirements must

include a clinical evaluation in accordance with Annex X.
Technical
department,.
quality
department
II.REQUIREMENTS REGARDING DESIGN AND CONSTRUCTION

7.
Chemical, physical and biological properties
7.1
The devices must be designed and manufactured in such a way as to guarantee the Y
characteristics and performances referred to in Section 1 on the "General
requirements". Particular attention must be paid to:
Quality dpt.

Document BYQA031-00
III.-2
Revision
CE Technical File
Part A
Applicable
(Y/N)
7.2
7.3
the choice of materials used, particularly as regards toxicity and, where appropriate Y
flammability,
the compatibility between the materials used and biological tissues, cells and body
fluids, taking account of the intended purpose of the device.
where appropriate, the results of biophysical or modelling research

whose validity has been demonstrated beforehand.
Requirements
Standard
Conformity of
Manufacturer
Responsible/
Justification
Quality dpt.
ISO10993-1
ISO10993-5,-10
ISO10993-1
ISO10993-5,-10
Biocompatibility
test report
The devices must be designed, manufactured and packed in such a way as to Y

minimise the risk posed by contaminants and residues to the persons involved in the
transport, storage and use of the devices and to the patients, taking account of the
intended purpose of the product. Particular attention must be paid to the tissues
exposed and the duration and frequency of the exposure.
ISO14971:2007
Risk management Technic

report
dpt.
,quality
The devices must be designed and manufactured in such a way that they can be used Y
safely with the materials, substances and gases with which they enter into contact
during their normal use or during routine procedures; if the devices are intended to
administer medicinal products they must be designed and manufactured in such a way
as to be compatible with the medicinal products concerned according to the provisions
and restrictions governing those products and that their performance is maintained in
accordance with the intended use.
ISO14971:2007
Risk management Technic

report
dpt.
,quality
Biocompatibility
test report
Quality dpt.

Document BYQA031-00
III.-2
Revision
CE Technical File
Part A
Applicable
Conformity of
Manufacturer
Responsible/
Where a device incorporates, as an integral part, a substance which, if used N/A

separately, may be considered to be a medicinal product as defined in Article
1 of Directive 2001/83/EC and which is liable to act upon the body with action
ancillary to that of the device, the quality, safety and usefulness of the
substance must be verified by analogy with the methods specified in Annex I
to 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 part
of the medical device and taking account of the intended purpose of the
device, seek a scientific opinion from one of the competent authorities
designated 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 the
clinical benefit/risk profile of the incorporation of the substance into the device.
When issuing its opinion, the competent authority or the EMEA shall take into
account the manufacturing process and the data related to the usefulness of
incorporation of the substance into the device as determined by the notified
body.
N/A
N/A
Justification
N/A
Where a device incorporates, as an integral part, a human blood derivative, N/A

the notified body shall, having verified the usefulness of the substance as part
of the medical device and taking into account the intended purpose of the
device, seek a scientific opinion from the EMEA, acting particularly through its
committee, on the quality and safety of the substance including the clinical
benefit/risk profile of the incorporation of the human blood derivative into the
device. When issuing its opinion, the EMEA shall take into account the
manufacturing process and the data related to the usefulness of incorporation
of the substance into the device as determined by the notified body.
N/A
N/A
N/A
(Y/N)
7.4
Requirements
Standard
10

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III.-2
Revision
CE Technical File
Part A
Applicable
(Y/N)
7.5
Where changes are made to an ancillary substance incorporated in a device, N/A

in particular related to its manufacturing process, the notified body shall be
informed of the changes and shall consult the relevant medicines competent
authority (i.e. the one involved in the initial consultation) , in order to confirm
that the quality and safety of the ancillary substance are maintained. The
competent authority shall take into account the data related to the usefulness
of incorporation of the substance into the device as determined by the notified
body, in
()Regulation (EC) No 726/2004 of the European Parliament and of the
Council of 31 March 2004 laying down Community procedures for the
authorization and supervision of medicinal products for human and veterinary
use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p.
1) . Regulation as last amended by Regulation (EC) No 1901/2006.
The devices must be designed and manufactured in such a way as to Y
reduce to a minimum the risks posed by substances leaking from the
device. Special attention shall be given to substances which are
carcinogenic, mutagenic or toxic to reproduction, in accordance with
Annex I to Council Directive 67/548/EEC of 27 June 1967 on the
approximation of laws, regulations and administrative provisions relating
to the classification, packaging and labeling of dangerous substances (*) .
If parts of a device (or a device itself) intended to administer and/or
remove medicines, body liquids or other substances to or from the body,
or devices intended for transport and storage of such body fluids or
substances, contain phthalates which are classified as carcinogenic,
mutagenic or toxic to reproduction, of category 1 or 2, in accordance with
Annex I to Directive 67/548/EEC, these devices must be labeled on the
device itself and/or on the packaging for each unit or, where appropriate,
on the sales packaging as a device containing phthalates.
Requirements
Standard
Conformity of
Manufacturer
Responsible/
N/A
N/A
Justification
N/A
PVC material,but
phthalates are
compliance with
ROHS requirement
Supplier report
Quality dpt
11

Document BYQA031-00
III.-2
Revision
CE Technical File
Part A
Applicable
(Y/N)
7.6
If the intended use of such devices includes treatment of children or N/A

treatment of pregnant or nursing women, the manufacturer must provide a
specific justification for the use of these substances with regard to
compliance with the essential requirements, in particular of this paragraph,
within the technical documentation and, within the instructions for use,
information on residual risks for these patient groups and, if applicable, on
appropriate precautionary measures
The devices must be designed and manufactured in such a way as to reduce as much Y
Requirements
Standard
Conformity of
Manufacturer
Responsible/
Justification
N/A
N/A
N/A
ISO14971:2009
Risk mangement Techinic,quality

report
Dpt.
NA
Supplier report
as possible, risks posed by the unintentional ingress of substances into the device
taking into account the device and the nature of the environment in which it is intended
to be used.
8.
Infection and microbial contamination
8.1
The devices and their manufacturing processes must be designed in such a way as to Y
eliminate or reduce as far as possible the risk of infection to the patient, user and third
parties. The design must allow easy handling and, where necessary, minimise
contamination of the device by the patient or vice versa during use.
8.2
Tissues of animal origin must originate from animals that have been subjected to
veterinary controls and surveillance adapted to the intended use of the tissues.
N/A
N/A
N/A
N/A
Notified Bodies shall retain information on the geographical origin of the animals.
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Processing, preservation, testing and handling of tissues, cells and substances of

animal origin must be carried out so as to provide optimal security. In particular safety
with regard to viruses and other transferable agents must be addressed by
implementation of validated methods of elimination or viral inactivation in the course of
the manufacturing process.
8.3
Devices delivered in a sterile state must be designed, manufactured and packed in a Y

non-reusable pack and/or according to appropriate procedures to ensure they are
sterile when placed on the market and remain sterile, under the storage and transport
conditions laid down, until the protective packaging is damaged or opened.
ISO11607,
ISO11737
Technic,producti
on Dpt.
Contract
sterile Technic,producti
agreement; sterile on Dpt.
valiation report
12

Document BYQA031-00
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CE Technical File
Part A
Applicable
(Y/N)
Requirements
Standard
ISO 11135-1
Conformity of
Manufacturer
Contract steriler
agreement
/
sterile validation
Contract steriler
agreement
/
sterile validation
Environment
control procedure
Responsible/
Justification
Techinic,quality
dpt ; contract
steriler
Techinic,quality
dpt ; contract
steriler
8.4
Devices delivered in a sterile state must have been manufactured and sterilised by an
appropriate, validated method.
8.5
Devices intended to be sterilised must be manufactured in appropriately controlled Y

(e.g. environmental) conditions.
8.6
Packaging systems for non-sterile devices must keep the product without deterioration Y
at the level of cleanliness stipulated and, if the devices are to be sterilised prior to use,
minimise the risk of microbial contamination. The packaging system must be suitable
taking account of the method of sterilisation indicated by the manufacturer.
8.7
The packaging and/or label of the device must distinguish between identical or similar Y
products sold in both sterile and non-sterile condition.
9.
Construction and environmental properties
9.1
If the device is intended for use in combination with other devices or equipment, the N/A
whole combination, including the connection system must be safe and must not impair
the specified performance of the devices. Any restrictions on use must be indicated on
the label or in the instruction for use.
9.2
Devices must be designed and manufactured in such a way as to remove or minimise N/A
as far as possible:
N/A
N/A
N/A
the risk of injury, in connection with their physical features, including the
volume/pressure ratio, dimensional, and where appropriate the ergonomic
features,
N/A
N/A
N/A
N/A
risks connected with reasonably foreseeable environmental conditions, such as

magnetic fields, external electrical influences, electrostatic discharge, pressure,
temperature or variations in pressure, and acceleration,
N/A
N/A
N/A
N/A
the risks of reciprocal interference with other devices normally used in the
investigations or for the treatment given,
N/A
N/A
N/A
N/A
ISO 11135-1
EN980:2008
N/A
Label requirement
N/A
N/A
13

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CE Technical File
Part A
Applicable
(Y/N)
Requirements
Standard
Conformity of
Manufacturer
Responsible/
Justification
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.
9.3
Devices must be designed and manufactured in such a way as to minimise the risks of N/A
fire or explosion during normal use and in single fault condition. Particular attention
must be paid to devices whose intended use includes exposure to flammable
substances which could cause combustion.
N/A
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 way N/A
as to provide sufficient accuracy and stability within appropriate limits of accuracy and
taking account of the intended purpose of the device. The limits of accuracy must be
indicated by the manufacturer.
N/A
N/A
N/A
10.2
The measurement, monitoring and display scale must be designed in line with N/A
ergonomic principles, taking account of the intended purpose of the device.
N/A
N/A
N/A
10.3
The measurements made by devices with a measuring function must be expressed in N/A
legal 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
N/A
11.
Protection against radiation
14

Document BYQA031-00
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Part A
Applicable
(Y/N)
11.1
11.1.1
General
N/A
Requirements
Standard
Conformity of
Manufacturer
Responsible/
N/A
N/A
Justification
N/A
N/A
N/A
N/A
Devices shall be designed and manufactured such that exposure of patients, users
and other persons to radiation shall be reduced as far as possible compatible with the
intended purpose, whilst not restricting the application of appropriate specified levels
for therapeutic and diagnostic purposes.
11.2
11.2.1
Intended radiation
N/A
Where devices are designed to emit hazardous levels of radiation necessary for a
specific medical purpose the benefit of which is considered to outweigh the risks
inherent in the emission, it must be possible for the user to control the emissions. Such
devices shall be designed and manufactured to ensure reproducibility and tolerance of
relevant variable parameters.
11.2.2
Where devices are intended to emit potentially hazardous, visible and/or invisible N/A
radiation, they must be fitted, where practicable, with visual displays and/or audible
warnings of such emissions.
11.3
11.3.1
Unintended radiation
N/A
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.
15

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Part A
Applicable
(Y/N)
11.4
Instructions
11.4.1
The operating instructions for devices emitting radiation must give detailed information
as to the nature of the emitted radiation, means of protecting the patient and the user
and on ways of avoiding misuse and of eliminating the risks inherent in installation.
11.5
11.5.1
Ionising radiation
Requirements
Standard
Conformity of
Manufacturer
Responsible/
Justification
NA
NA
NA
NA
N/A
N/A
N/A
N/A
11.5.2
Devices emitting ionising radiation intended for diagnostic radiology shall be designed N/A
and manufactured in such a way, as to achieve appropriate image and/or output
quality for the intended medical purpose whilst minimising radiation exposure of the
patient and user.
N/A
N/A
N/A
11.5.3
Devices emitting ionising radiation intended for therapeutic radiology shall be designed N/A
and manufactured in such a way as to enable reliable monitoring and control of the
delivered dose, the beam type and energy and where appropriate the quality of the
radiation.
N/A
N/A
N/A
12.
Requirements for medical devices connected to or equipped with an energy

source
12.1
Devices incorporating electronic programmable systems must be designed to ensure N/A

the repeatability, reliability and performance of these systems according to their
intended 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.
N/A
N/A
N/A
Devices intended to emit ionising radiation must be designed and manufactured in

such a way as to ensure that, where practicable, the quantity, geometry and quality of
radiation emitted can be varied and controlled taking into account the intended uses.
16

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Part A
Applicable
(Y/N)
12.1a
12.2
12.3
For devices which incorporate software or which are medical software in N/A
themselves, the software must be validated according to the state of the
art taking into account the principles of development lifecycle, risk
management, validation and verification.
Devices where the safety of the patients depends on an internal power supply must be N/A
equipped with a means of determining the state of the power supply.
Devices where the safety of the patient depends on an external power supply must N/A
Requirements
Standard
Conformity of
Manufacturer
Responsible/
N/A
N/A
Justification
N/A
N/A
N/A
N/A
N/A
N/A
N/A
ISO14971
Risk management R&D ,marketing

report
department
include an alarm system to signal any power failure.

12.4
Devices intended to monitor one or more clinical parameters of a patient must be N/A
equipped with appropriate alarm systems to alert the user of situations which could
lead to death or severe deterioration of the patient's state of health.
12.5
Devices must be designed and manufactured in such a way as to minimise the risks of N/A
creating electromagnetic fields which could impair the operation of other devices or
equipment in the usual environment.
12.6
N/A
Protection against electrical risks
Devices must be designed and manufactured in such a way as to avoid, as far as
possible, the risk of accidental electric shocks during normal use and in single fault
condition, provided that the devices are installed correctly.
12.7
12.7.1
Protection against mechanical and thermal risks

Devices must be designed and manufactured in such a way as to protect the patient
and user against mechanical risks connected with, for example, resistance, stability
and moving parts.
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Part A
Applicable
Requirements
Standard
Conformity of
Manufacturer
Responsible/
12.7.2
Devices must be designed and manufactured in such a way as to reduce to the lowest N/A
possible level the risks arising from vibration generated by the devices, taking account
of technical progress and of the means available for limiting vibrations, particularly at
source, unless the vibrations are part of the specified performance.
N/A
N/A
Justification
N/A
12.7.3
Devices must be designed and manufactured in such a way as to reduce to the lowest N/A
possible level the risks arising from the noise emitted, taking account of technical
progress and of the means available to reduce noise, particularly at source, unless the
noise emitted is part of the specified performance.
N/A
N/A
N/A
12.7.4
The terminals and connectors to the electricity, gas or hydraulic and pneumatic energy N/A
supplies which the user has to handle must be designed and constructed in such a
way as to minimise all possible risks.
N/A
N/A
N/A
12.7.5
Accessible parts of devices (excluding any parts or areas intended to supply heat or N/A
reach given temperatures) and their surroundings must not attain potentially
dangerous temperatures under normal use.
N/A
N/A
N/A
12.8
Protection against the risks posed to the patient by energy supplies or substances
N/A
N/A
N/A
N/A
12.8.1
Devices for supplying the patient with energy or substances must be designed and
constructed in such a way that the flow rate can be set and maintained accurately
enough to guarantee the safety of the patient and of the user.
Devices must be fitted with the means of preventing and/or indicating any N/A
inadequacies in the flow-rate which could pose a danger.
N/A
N/A
N/A
EN980:2008
EN1041:2008
Label, instruction techinic

for us
deparment
(Y/N)
12.8.2
Devices must incorporate suitable means to prevent, as far as possible, the accidental
release of dangerous levels of energy from an energy and/or substance source.
12.9
The function of the controls and indicators must be clearly specified on the devices.
Where a device bears instructions required for its operation or indicates operating or
adjustment parameters by means of a visual system, such information must be
understandable to the user and, as appropriate, to the patient.
18

Document BYQA031-00
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Part A
Applicable
(Y/N)
13.
Information supplied by the manufacturer
13.1
Each device must be accompanied by the information needed to use it Y

safely and properly, taking account of the training and knowledge of the
potential users, and to identify the manufacturer
Where appropriate, this information should take the form of symbols. Any symbol or Y
13.2
identification colour used must conform to the harmonised standards. In areas for
which no standards exist, the symbols and colours must be described in the
documentation supplied with the device.
13.3
Requirements
Standard
Conformity of
Manufacturer
Responsible/
Justification
EN980:2008
EN1041:2008
Label, instruction Marketing

for us
deparment
EN980:2008
EN1041:2008
Label, instruction Marketing

for us
deparment
The label must bear the following particulars:
the name or trade name and address of the manufacturer. For devices Y
imported into the Community, in view of their distribution in the
Community, the label, or the outer packaging, or instructions for use,
shall contain in addition the name and address of the authorised
representative where the manufacturer does not have a registered
place of business in the Community;
b) the details strictly necessary to identify the device and the contents of Y
the packaging especially for the users;
EN980:2008
EN1041:2008
Label,
Labeling
instruction
for us
EN980:2008
EN1041:2008
Labelling
EN980:2008
EN1041:2008
Shelflife
analysis,steady
analysis report
a)
d) where appropriate, the batch code, preceded by the word "LOT", or the serial Y
number;
EN980:2008
Label,
instruction
for us
Label,
instruction
for us
Label
e) where appropriate, an indication of the date by which the device should be used, in Y
safety, expressed as the year and month;
EN980:2008
Label
c) where appropriate, the word "STERILE";
Techinic,quality
dpt ; contract
steriler
19

Document BYQA031-00
III.-2
Revision
CE Technical File
Part A
Applicable
(Y/N)
f) where appropriate, an indication that the device is for single use. A Y
Requirements
Standard
Conformity of
Manufacturer
EN980:2008
Label
EN980:2008
Label
EN980:2008
Label
EN980:2008
EN980:2008
EN1401:2008
EN980:2008
Label
Label
Responsible/
Justification
Label
manufacturer's indication of single use must be consihearing aid across

the Community;
13.3
Y
h) if the device is intended for clinical investigations, the words "exclusively for clinical Y
g)
if the device is custom made, the words "custom made device";
investigations";
Y
Y
j) any special operating instructions;
Y
k) any warnings and/or precautions to take;
l) year of manufacture of active devices other than those covered by e). This Y
i)
any special storage and/or handling conditions;
Label
Label
indication may be included in the batch or serial number;
N/A
If the intended purpose of the device is not obvious to the user, the manufacturer must Y
m) where applicable, method of sterilisation.
13.4
N/A
EN1041:2008
N/A
Instruction for use
EN1041:2008
Instruction for use
EN1041:2008
EN1041:2008
N/A
Instruction for use

Instruction for use
N/A
N/A
clearly state it on the label and in the instructions for use.

13.5
Wherever reasonable and practicable, the devices and detachable components must Y
be identified, where appropriate in terms of batches, to allow all appropriate action to
detect any potential risk posed by the devices and detachable components.
13.6
Where appropriate for use, the instructions must contain the following particulars:
Y
b) the performances referred to in section 3 and any undesirable side effects;
Y
c) if the device must be installed with or connected to other medical devices or N/A
a) the details referred to in 13.3, with the exception of d) and e)
equipment 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 to
obtain a safe combination;
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Document BYQA031-00
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Part A
Applicable
(Y/N)
13.6
Requirements
Standard
Conformity of
Manufacturer
d) all the information needed to verify whether the device is properly installed and can Y
operate correctly and safely, plus details of the nature and frequency of the
maintenance and calibration needed to ensure that the devices operate properly
and safely at all times;
EN1041:2008
Instruction for use
e) where appropriate, information to avoid certain risks in connection with implantation Y

of the device;
EN1041:2008
Instruction for use
f) information regarding the risks of reciprocal interference posed by the presence of Y

the device during specific investigations or treatment;
EN1041:2008
Instruction for use
g) the necessary instructions in the event of damage to the sterile packaging and, Y
where appropriate, details of appropriate methods of re-sterilisation;
EN1041:2008
Instruction for use
h) if the device is reusable, information on the appropriate processes to allow reuse, Y

including cleaning, disinfection, packaging and, where appropriate, the method of
sterilisation of the device to be re-sterilised, and any restriction on the number of
reuses.
EN1041:2008
Instruction for use
EN1041:2008
Instruction for use
Responsible/
Justification
Where devices are supplied with the intention that they may be sterilised before
use, the instructions for cleaning and sterilisation must be that, if correctly followed,
the device will still comply with the requirements in Section I;
If the device bears an indication that the device is for single use,
information on known characteristics and technical factors known to the
manufacturer that could pose a risk if the device were to be re-used. If in
accordance with Section 13.1 no instructions for use are needed, the
information must be made available to the user upon request;
i) details of any further treatment or handling needed before the device can be used Y
(for example, sterilisation, final assembly, etc.);
j) in the case of devices emitting radiation for medical purpose, details of the nature, N/A
type intensity and distribution of this radiation.
The instruction for use must also include details, allowing the medical staff to brief the
patient on any contra-indications and any precautions to be taken. These details
should cover in particular:
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Part A
Applicable
(Y/N)
Requirements
Standard
Conformity of
Manufacturer
Responsible/
EN1041:2008
Instruction for use
l) precautions to be taken as regards exposure, in reasonably foreseeable Y

environmental conditions, to magnetic fields, external electrical influences,
electrostatic discharge, pressure or variations in pressure, acceleration, thermal
ignition sources etc.;
EN1041:2008
Instruction for use
EN1041:2008
Instruction for use Y
EN1041:2008
Instruction for use
k) precautions to be taken in the event of changes in the performance of the device;
Justification
m) adequate information regarding the medicinal product or products which the device N/A
in question is designed to administer, including any limitations in the choice of
substances to be delivered;
n) precautions to be taken against any special, unusual risks related to the disposal of Y
the device;
medicinal substances, or human blood derivatives incorporated into N/A

the device as an integral part in accordance with Section 7.4;
p) degree of accuracy claimed for devices with a measuring function.
N/A
o)
q) date of issue or the latest revision of the instructions for use
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Document BYQA031-00
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Part A
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 medical
circle 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.
Its 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
II.
Mr.
Peng
Mr.
Mr.
Guansanchao
Zhujianxing
QA Manager/Management Rep.
Product Engineer
Technical Dept. Manager ()
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
Feedback information from customer
Samples from other manufacturers
Dialect of newspapers and journalists
Observation and research of market requirement
Information during the development
III. Members of the Risk Analysis Team

Team 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 be
discovered.
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
Project director, who is responsible for the planning and reviewing of
Team leader
the procedure of risk analysis
Evaluate the probability of generation of hardware failure from the
Plant manager
point of view of technique
Identify the possible defect of manufacture from the point of view of
QMr
technique
23

Document BYQA031-00
Production
Manager
Regulatory
affairs
engineer
QM
QA
Marketing
Manager
Revision
CE Technical File
Part A
Evaluate the possible misuse of operator from the point of view of

package, label and transportation
Affairs of regulatory and EC harmonized standards applied to the
product
clinical information
bio-compatibility standards applied to the product
application and affection of adverse events.
IV. Risk management procedure

1. Judgment list of character concerning with risk
2. Risk management at the stage of post-product
stage of product
realization
design input
Review action
Design input review
sample
Sample review
polite manufacture Design review I I
clinic stage
Design review II II
post- product Annual management review
Verification activate
The verification of the implement of risk control measure will be checked by inspection of
the risk management files .
The verification of the effectiveness will be checked by inspection of the result of the risk
management.
3. Estimation of the occurrence probability of each hazard

3.1 Quantities and Qualitative Determination of the Features of the Applicant Medical Device
Following 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 NameWound Drainage System
Device Classification:
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
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?
Description
1. Intended use : The Closed Wound Drainage System
is used for sucking the wasted liquor from the patients
body when pressing the wound drainage cavity with the
trocar puncturing the patients 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.
Is special intervention
necessary in the case of failure
of the medical device?
Are there special concerns
about interface design features
that could contribute to
inadvertent use error?
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 the
risk or complications arising from the patients degree
of intolerance to any foreign object placed in the body.
Do not re-sterilize.
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 frequency
of contact.
Wound drainage system is internal device which is used

to sucking the wasted liquid in patients 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
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 on
stomach clairvoyance, is well
recognized as a safe reagent
clinicly.
10
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.
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 of
substances, the maximum and minimum transfer rates and
control thereof.
No
The process will be operated by

the
professional
doctor
staff.
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 .
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
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 doctors
Prescription, suck the liquid
on the partial of the patient,
so relax the patient. The
temperature can be
ameliorated.
There is a scale on the side of
the reservoir body, it can
measure the quantity of the
wasted liquid.
No
Are measurements taken? Factors that should be

considered include the variables measured and the
accuracy and the precision of the measurement results.
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.
26

Document BYQA031-00
Item
Revision

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.
11
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.
12
Part A
CE Technical File
Description
No
The connecting tube only

insert
the
drainage
partial, and controlled
the quantity of the
liquid.
Substance-related factors that should be considered include

discharge of chemicals, waste products and body fluids.
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
13
Are there essential consumables or accessories associated with

the medical device?
The device transportation

and storage should be in
the condition of less than
40 humidity less
than 80%.
The device used in the
operating room.
No
14
Factors that should be considered include specifications
For such consumables or accessories and any restrictions placed upon
users in their selection of these.
Is maintenance and /or calibration necessary?

15
No
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?
Does the medical device contain software?
No
Factors that should be considered include whether software is intended
16
to be installed, verified, modified or Exchanged by the user and /or

operator.
The expiration date is five

years, which will be
that should be considered include labeling or indicators and labeled on the package. It
can be handled according
the disposal of such medical devices.
to the law and the
regulation of the country if
it had exceeded the
expiration date.
Does the medical device have a restricted shelf life? Factors
17
Item
Description
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Are there any delayed and/or long-term use effects? Factors

that should be considered include ergonomic and cumulative
effects.
No
The device depend on
19
20
21
22
23
24
25
To what mechanical forces will the medical device be

the compression spring
subjected?
come into suppressing and
Factors that should be considered include whether the Forces to sucking the wasted liquid.
which the medical device will be subjected are under the
control of the user or controlled by interaction Which other
persons
The aging of the raw
What determines the lifetime of the medical device?
material has determined
Factors that should be considered Include ageing and battery the products life
depletion.
expectancy.
Sign use only.
Is the medical device intended for Single use?
Is safe decommissioning or disposal Of the medical device
necessary? 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 device

should
be
handled
according to the laws or
regulations of that country.
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.
Will new manufacturing processes need to be established or
introduced. The introduction of new hazard(s)(e.g.new
technology, new scale of production).
The direction of use is

provided in the packing
label. The user should be
professional doctor or
nursing stuff.
No
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?
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 of
use on the manual
Is the medical device controlled by a menu?

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Part A
Item
Description
26
Is the medical device intended to be mobile or portable? Factors that

should be considered are the necessary grips, handles, wheels,
brakes, mechanical stability and durability.
The hanger of the wound

drainage system should be set
firm enough to bear the weight
of the wasted liquid.
The product is sign use
only, it does need to clean
and sterile before use.
Ensure the endotoxin are
not overweight
Does the device should be cleaned and steriled before use.

How frequency does the clean and sterile do ?
27
prepared Terry Tan
reviewed: Zhu jianxin
4. Definition criterial
4.1 criteria of severity for harm
No. Category
Description
Examples
Negligible
No hazard occurs or almost

Skin irritation
no
Marginal
Hazard occurs possibly
Critical
myocardial
Potential of death or serious Acute
injury
infarction
Catastrophic
Death or
possibly
injure
Coronary arterial spasm
occurs
Death
4.2 Criteria of the probability for harm

No. Class
Description
Example
Incredible
Never occurred (<10-6)
Lack of sterility
Unlikely
The typical situation is it occurs once

No labeling
during its life time (10-6 -10-4)
Remote
The typical situation is it occurs no more

Product is used after
than once in 100 times of treatment (10-4
shelf-life
-10-2)
Occasional
Probable
Frequent
The typical situation is it occurs once in 10 Used by

times of treatment (10-2 -10-1)
person
The typical situation is it occurs once in Procedural
every treatment (10-1-1)
events
The typical situation is it occurs several
None
times in every treatment (>1)
unskilled
adverse
4.3 Criteria for risk acceptability

When Severity 4CAPA should been taken
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Part A
When Severity3 probability 5 CAPA should been taken

When Severity2 probability =6 CAPA should been taken
For the residual risk, CAPA should been taken for the top 20risk .
Severity
Likelihood
4 catastrophic
1 Negligible 2 Marginal 3 Critical
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:
Yes
Type of Hazard
Potential Hazard
1Energy
1.Pressure
No
Nor
mal
Failure
Risk
Factor
(the
Hazard container breaks
and leaks)
2.Biological hazard
Bio
Contamination
Bio
un-compatibility
Across infect
4.Hazard in
Applications of the
device
Improper
Packagethe
pollution or
metamorphism of
the medical
equipments
If yes (known, foreseen and

not confirmed), describe
potential hazard
The container is likely

to break or leak if the
up cover or bottom
cover
hit
sealing
unsteady.
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.
1The discarded
products and the
discharged liquid waste
should be handled
according to the laws
and regulations of that
country.
2Leakness
Inspection.
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3
5Hazards due to
Function Failure,
improper
Maintenance or
Aging
1Lack of Proper
The device has

exceeds the actual
expiration date and
that lead to the
aging of the product.
So the product cannot
be used regularly.
Regulation
on
End of ervice
Life
preparedTerry Tan
Part A
reviewed
Zhujianxin
2 other risk
Yes
Source of Hazard
No
Nor
mal
Potential
Hazard
Failure
Batch inconsistency Different batch

of manufacture
Common interfering
factor
Different
Environment
Carry-over effects
Sample
identification errors
If yes (known, foreseen

and not confirmed),
describe potential hazard
Risk
Factor
Intended usage
failure. Write clear
batch record, make
sure it is traceable.
Make sure the
environment of the
transportation and
storage are acceptable.
Finished good
inspection insure the
product clean and
qualify.
Sample validation
Stability problem Package damaged
preparedTerry Tan
The proficiency of
workers operation
reviewed Zhu jianxin
3.Analysis evaluation report

3.1. Risk evaluationaccording to criteria
Severity
Probability
1=negligible
1=incredible
2=marginal
2=unlikely
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3=critical
3=remote
4=catastrophic
4=occasional
CE Technical File
Part A
5=probable
6=frequent
Severity
probability
1
N/ACC
N/ACC
N/ACC
N/ACC
N/ACC
N/ACC
ACC
ACC
ACC
ACC
ACC
ACC
ACC
3.2 Risk estimation and risk evaluation
Energy
Hazards
harms
Potential causes
Risk
estimation
S
Trocar
sharpness
failure
Performance Barium tube
Risk
evaluation
R1: Trocar can not punch through the patient

body.
R1.1 residua on
trocar
N/ACC
R1.2 suction tube

block up
N/ACC
Rerservoir kit R1.3 suction failure3

5
N/ACC
leak
R2: separation of tubing in body
3.3 Risk control of R1
No.
R1
Hazard
Trocar failure, leak
Risk evaluation Can cause Acute myocardial infarction, dead.

S 3, P 5,
N/ACC
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Safe design and

protective measure
CE Technical File
Part A
controllable?
Yes
1. Sharpness ensurance 100% test.

Counter measures 2. risidua inspection
3. Leak test
Verification
Varification report
Residual risk
S 3, P 2,
Risk/benefit
analysis
benefit outweighs the risk
explaining
The Probability of tubing broke and lefe in patient body and cause patient decease to
unlikely level. As the reservoir kit system have been broadly used worldwide for many
years, and the benefit of reservoir kit is obvious weighting profit against potential
hazards
New risk
No
ACC
3.4 Evaluating effectiveness of risk control measure

DHR review.
4.Risk and profit analysis
From 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. Summary
The 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 the
incoming examination of raw material and auxiliary material, environment control, the manufacturing process, the final
inspection and sterilization validation. The biocompatibility test and clinical data prove that the products would not
cause 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 to
ensure the microbes pollution to the least level, within acceptable scope and in conformance with the requirements of
93/42/EEC as amended by 2007/47/EC. All the risk s are describes, evaluated and proved to be within acceptable
scope 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 patients body when pressing the wound drainage cavity with the trocar puncturing the patients body and
leading the X-ray barium tube. And the product is mainly made of non-toxic PVC and a trocar, so it do no harm to the
patients, 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 its
intended use. Beyonds manufacturing facility of the suction connecting tube has years of experience of making plastic
medical device for single use, and is running under the certified quality management system of ISO13485,as well as
CE.
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 products designing and developing, in the production procedure as well as after the collection of
the feedbacks. And we also adopted a series of efficient controlling measurement to deal with the possible dangers
which may occur in every stage. Thus, we have minimized the risks to the acceptable range and we assure that the
dangers 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 product
avoids us from any reports about unpleasant medical accidents caused by our equipments during the production and
clinical 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 the
Occident 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 ten
thousand wound drainage system by now. we havent received any complaints about unpleasant medical accidents or
quality problems caused by our equipment during the clinical use up to now. The result shows that our product is either
safe or reliable and the products quality is excellent.
5 Target market and sales volume
Major target market is North America, but we are developing Europe market. The sales volume may exceed 1 million
pcs within one or two years.
6.Product safety and effectiveness review
This 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 , the
sterility is assured.
There are warning words and precautions during condition of use indicated on the label, therefore, to
avoid 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 in
hospital. 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 Application
a) convenient and applicable for vacuum suctuion;
b) no other harm to patients;
7.4.4 Others
a) 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 customers
We 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 of
passed years, it has proven that our product is stable in quality, safe and reliable. The feedback fromour customers is
good; 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;
STERILE
EO
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
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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 a
symbol - 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 and
date 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 mark
shall 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 with
the regulations on procedure documents such as Controlling Procedures for Documents and Data and Controlling
Procedures for Quality System Document.
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Document BYQA031-00
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Part A
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 General
According 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 is
safe for its intended use.
8.2.2 Tested by Cardinal Health
8.2.3 Appendix
Appendix I
Test report of the Wound Drainage Suction Reservoir
Appendix II Retention sample test report
8.3 Aging Test

8.3.1 General
According to the ISO 11137:
obtain evidence that the product
2006,The aging test for five years has been performed so as to

is credible for its intended use in its 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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Document BYQA031-00
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Part A
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.
Components Name
FS/QR-7.6-02-01
IQ BeyondZ001
FS/QR-7.6-02-02
IQ BeyondZ002
FS/QR-7.6-02-03
IQ BeyondZ003
FS/QR-7.6-03-01
OQ-Plate of Cover OQ
FS/QR-7.6-03-02
PQ-Plate of Cover PQ
FS/QR-7.6-04-01
OQ-Plate of Bottom OQ
FS/QR-7.6-04-02
PQ-Plate of Bottom PQ
FS/QR-7.6-05-01
OQ- Drain Jaws OQ
FS/QR-7.6-05-02
PQ- Drain Jaws PQ
10
FS/QR-7.6-06-01
OQ- Entrance Jaws OQ
11
FS/QR-7.6-06-02
PQ- Entrance Jaws PQ
12
FS/QR-7.6-07-01
OQ- Bed Sheet OQ
13
FS/QR-7.6-07-02
PQ- Bed Sheet PQ
14
FS/QR-7.6-08-01
OQ- Robert Clamp OQ
15
FS/QR-7.6-08-02
PQ- Robert Clamp PQ
16
FS/QR-7.6-09-01
OQ- Barium Tube OQ
17
FS/QR-7.6-09-02
PQ- Barium Tube PQ
18
FS/QR-7.6-10-01
OQ- Connection Tube OQ
19
FS/QR-7.6-10-02
PQ- Connection Tube PQ
20
FS/QR-7.6-11-01
OQ- Cover for Trocar OQ
21
FS/QR-7.6-11-02
PQ- Cover for Trocar PQ
38

A
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Part
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 will
kept by Cardinal Health
shanghai.
9.4
9.5
9.6
Labeling Control
Refer to Changsu Beyond procedure XSLO-PP002, Rev 01.
Traceability
Refer to Changsu Beyond procedure XSPR-PP001, Rev 01.
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
39

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CE Technical File of Wound Drainage System

File No.: BYQA031-00

Product Master Document

Changshu Beyond Medical Device Co., Ltd

Issue Date: Mar 20th,2015

I. Product General Description

Wound Drainage System is made up of three springs reservoir body , connecting

II. System Set-up

Stainless Steel 304

Product Master Document

Changshu Beyond Medical Device Co., Ltd

Issue Date: Mar 20th,2015

1059B uncoated Tyvek

Alliantz Flexible Packaging,Pte,Ltd

Wuxi Jiahong Plastic Factory

Nantong Zhanglian Industry Development

Nantong Zhanglian Industry Development

Film of Cover, printed

Shanghai Baojia Plastic Factory

Bottom Film, printed

Shanghai Baojia Plastic Factory

Shanghai Baojia Plastic Factory

Product Master Document

Changshu Beyond Medical Device Co., Ltd

Issue Date: Mar 20th,2015

ChangshuBeyond Medical Device Co.,ltd

European Representative: Shanghai International Holding Corp. GMBHEurope

TV Product Service GmbH, Ridlerstr. 65, 80339

Place, Date of Issue:

Product Master Document

Changshu Beyond Medical Device Co., Ltd

Issue Date: Mar 20th,2015

III. List of Essential Requirement

Product Master Document

according to the Quality

Changshu Beyond Medical Device Co., Ltd

Issue Date: Mar 20th,2015

1. Package Qualification Certificate ;

Product Master Document

Changshu Beyond Medical Device Co., Ltd

Issue Date: Mar 20th,2015

Essential Requirements checking list of the MDD (07/47/EC)

to be used (design for patient safety), and

consideration of the technical knowledge, experience, education and

where appropriate take adequate protection measures including alarms if necessary,

Product Master Document

Changshu Beyond Medical Device Co., Ltd

Issue Date: Mar 20th,2015

Essential Requirements checking list of the MDD (07/47/EC)

The characteristics and performances referred to in sections 1, 2 and 3 must not be Y

Risk management Technical

Risk management Technical

6a. Demonstration of conformity with the essential requirements must

II.REQUIREMENTS REGARDING DESIGN AND CONSTRUCTION

Chemical, physical and biological properties

Product Master Document

Changshu Beyond Medical Device Co., Ltd

Issue Date: Mar 20th,2015

Essential Requirements checking list of the MDD (07/47/EC)

where appropriate, the results of biophysical or modelling research

The devices must be designed, manufactured and packed in such a way as to Y