03. '19년 터키 기술문서 예시

목 차
제3장 터키 기술문서 예시 – 3
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Technical Construction File
For
Model Name
Development Team Manager R&D Manager
(signature) (signature)
(name) (name)
(date) (date)
Co., Ltd.
- 3 -
xxTCF-00
Table of Content
(name) (name)
(date) (date)
Co., Ltd.
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Table of contents
File No. Title Rev. No Date
xxTCF-00 Table of Contents 0
xxTCF-01 General Information 0
Compliance Checklist of Essential

xxTCF-02 0
Requirements
Device Description (Attach: User

xxTCF-03 0
manual)
xxTCF-04 Key Component 0
xxTCF-05 Manufacturing and Quality Control 0
xxTCF-06 Test Reports (Attach: Test Report) 0
xxTCF-07 Risk Analysis 0
xxTCF-08 Labeling & Packaging 0
xxTCF-09 Clinical Evaluation Report 0
xxTCF-10 Software Validation Report 0
xxTCF-11 Biological Safety Assessment Report 0
xxTCF-12 Usability engineering file 0
xxTCF-13 Post Market Follow-up 0
xxTCF-14 EC Declaration of Conformity 0
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xxTCF-01
General Information
(name) (name)
(date) (date)
Co., Ltd.
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1.1 Introduction
This Technical Construction File consists of technical documentation related to

products of Electrosurgical Unit. It meets the requirements of the Medical Device
Directive 93/42/EEC as amended by Directive 2007/47/EC and is requested to bear the
CE mark to enable them to move freely within the European Community and to be put
into service in accordance with its intended purpose.
1.2 Class of Product

1.2.1 Classification of device
The manufacturer should first decide if the product concerned is a medical device
as defined in the Directive 07/47/EC or an accessory to such a medical device and if
it therefore comes within the scope of this directive.
▪ Duration
- Transient
▪ Active devices
Any medical device the operation of which depends on a source of electrical

energy or any source of power other than that directly generated by the human
body or gravity and which acts by converting this energy.
▪ Medical Device Class: IIb
Medical Device Class is determined by the standard for classification as below.
We selected the highest class after checking whether the lists for classification are
relevant to this product.
Standard for classification class A or N/A

1. Non-invasive devices
Rule 1
All non-invasive devices are in Class I, unless one of I N/A

the rules set out hereinafter applies.
Rule 2
All non-invasive devices intended for channelling or IIa N/A
storing blood, body liquids or tissues, liquids or gases for
the purpsose of eventual infusion, administration or
introduction into the body are in Class IIa:
- if they may be connected to an active medical device
in Class IIa or a higher class,
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- if they are intended for use for storing or channelling IIa N/A
blood or other body liquids or for storing organs, parts
of organs or body tissues,
- in all other cases they are in Class I. I N/A

Rule 3
- All non-invasive devices intended for modifying the IIb N/A

biological or chemical composition of blood, other body
liquids or other liquids intended for infusion into the body
are in Class IIb,
- unless the treatment consists of filtration, centrifugation IIa N/A

or exchanges of gas, heat, in which case they are in
Class IIa.
Rule 4
All non-invasive devices which come into contact with I N/A

injured skin:
- are in Class I if they are intended to be used as a
mechanical barrier, for compression or for absorption of
exudates,
IIb N/A
- are in Class IIb if they are intended to be used
principally with wounds which have breached the dermis
and can only heal by secondary intent,
IIa N/A
- are in Class IIa in all other cases, including devices

principally intended to manage the micro-environment
of a wound.
2. Invasive devices
Rule 5
All invasive devices with respect to body orifices, other
than surgically invasive devices and which are not
intended for connection to an active medical device:
- are in Class I if they are intended for transient use, I N/A
- are in Class IIa if they are intended for short-term use, IIa N/A
- except if they are used in the oral cavity as far as the I N/A
pharynx, in an ear canal up to the ear drum or in a
nasal cavity, in which case they are in Class I,
IIb N/A
- are in Class IIb if they are intended for long-term use,
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- except if they are used in the oral cavity as far as the IIa N/A
pharynx, in an ear canal up to the ear drum or in a
nasal cavity and are not liable to be absorbed by the
mucous membrane, in which case they are in Class IIa.
-All invasive devices with respect to body orifices, other IIa N/A
than surgically invasive devices, intended for connection
to an active medical device in Class IIa or a higher class,
are in Class IIa.
Rule 6
All surgically invasive devices intended for transient use IIa N/A
are in Class IIa unless they are:
- intended specifically to diagnose, monitor or correct a

defect of the heart or of the central circulatory system III N/A
through direct contact with these parts of the body, in
which case they are in Class III,
- reusable surgical instruments, in which case they are in

Class I, I N/A
- intended to supply energy in the form of ionizing IIb N/A

radiation in which case they are in Class IIb,
- intended to have a biological effect or to be wholly or

IIb N/A
mainly absorbed in which case they are in Class IIb,
- intended to administer medicines by means of a

delivery system, if this is done in a manner that is IIb N/A
potentially hazardous taking account of the mode of
application, in which they are in Class IIb.
Rule 7
All surgically invasive devices intended for short-term use IIa N/A
are in Class IIa unless they are intended:
- either specifically to diagnose, monitor or correct a

defect of the heart or of the central circulatory system III N/A
through direct contact with these parts of the body, in
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- or specifically for use in direct contact with the III N/A
central nervous system, in which case they are in Class
III,
- or to supply energy in the form of ionizing radiation in IIb N/A

which case they are in Class IIb,
- or to have a biological effect or to be wholly or mainly III N/A

absorbed in which case they are in Class III,
- or to undergo chemical change in the body, except if

the devices are placed in the teeth, or to administer IIb N/A
medicines, in which case they are in Class IIb.
Rule 8
All implantable devices and long-term surgically IIb N/A
invasive devices are in Class IIb unless they are intended:
- to be placed in the teeth, in which case they are in

Class IIa, IIa N/A
- to be used in direct contact with the heart, the central III N/A
circulatory system or the central nervous system, in
III N/A
- to have a biological effect or to be wholly or mainly
absorbed, in which case they are in Class III,
- or to undergo chemical change in the body, except if III N/A

the devices are placed in the teeth, or to administer
medicines, in which case they are in Class III.
3. Additional rules applicable to active devices
Rule 9
- All active therapeutic devices intended to administer or IIa N/A
exchange energy are in Class IIa
- unless their characteristics are such that they may

administer or exchange energy to or from the human IIb A
body in a potentially hazardous way, taking account of
the nature, the density and site of application of the
energy, in which case they are in Class IIb.
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- All active devices intended to control or monitor the
performance of active therapeutic devices in Class IIb,
or intended directly to influence the performance of such IIb N/A
devices are in Class IIb.
Rule 10
Active devices intended for diagnosis are in Class IIa: IIa N/A
- if they are intended to supply energy which will be IIa N/A

absorbed by the human body, except for devices used to
illuminate the patient's body, in the visible spectrum,
- if they are intended to image in vivo distribution of IIa N/A

radiopharmaceuticals,
IIa N/A
- if they are intended to allow direct diagnosis or
monitoring of vital physiological processes,
IIb N/A
- unless they are specifically intended for monitoring of
vital physiological parameters, where the nature of
variations is such that it could result in immediate danger
to the patient, for instance variations in cardiac
performance, respiration, activity of CNS in which case
they are in Class IIb.
IIb N/A
-Active devices intended to emit ionizing radiation and
intended for diagnostic and therapeutic interventional
radiology including devices which control or monitor such
devices, or which directly influence their performance,
are in Class IIb.
Rule 11
All active devices intended to administer and/or remove IIa N/A
medicines, body liquids or other substances to or from
the body are in Class IIa, unless this is done in a
manner:
- that is potentially hazardous, taking account of the IIb N/A

nature of the substances involved, of the part of the
body concerned and of the mode of application in which
case they are in Class IIb.
Rule 12
All other active devices are in Class I. I N/A

4. Special Rules
Rule 13
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All devices incorporating, as an integral part, a substance III N/A
which, if used separately, can be considered to be a
medicinal product, as defined in Article 1 of Directive
65/65/EEC, and which is liable to act on the human body
with action ancillary to that of the devices, are in Class
III.
Rule 14
All devices used for contraception or the prevention of IIb N/A
the transmission of sexually transmitted diseases are in
Class IIb,
- unless they are implantable or long term invasive III N/A

devices, in which case they are in Class III.
Rule 15
All devices intended specifically to be used for IIb N/A
disinfecting, cleaning, rinsing or, when appropriate,
hydrating contact lenses are in Class IIb.
All devices intended specifically to be used for disinfecting IIa N/A

medical devices are in Class IIa. This rule does not
apply to products that are intended to clean medical
devices other than contact lenses by means of physical
action.
Rule 16
Non-active devices specifically intended for recording of IIa N/A
X-ray diagnostic images are in Class IIa.
Rule 17
All devices manufactured utilizing animal tissues or III N/A
derivatives rendered non-viable are Class III except where
such devices are intended to come into contact with
intact skin only.
Rule 18
By derogation from other rules, blood bags are in Class IIb. IIb N/A
▪ Classification Result Summary
Product Name
Model Name
Intended Use
Applicable Rule Number Classification
Rule 9 IIb
The highest Classification IIb
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1.3 Manufacturer
1) Mailing address :
2) Office address :
3) Telephone :
1.4 Applicable normative references

Standard No. Standard Title
EN 60601-1(2006) Medical electrical equipment - Part 1:General requirements
for basic safety and essential performance
EN 60601-1-2(2007) Medical electrical equipment - Part 1:General requirements
for safety
Collateral Standard: Electromagnetic compatibility –

Requirements and tests
EN 60601-1-8(2007) Medical electrical equipment - Part 1-8:General
requirements for safety – Collateral Standard: General
requirements, tests and guidance for alarm systems in
medical electrical equipment and medical electrical systems
EN 60601-1-6(2010) Medical electrical equipment – Part 1-6:General
requirements for basic safety and essential performance –
Collateral standard : Usability
IEC 62366(2007) Medical device – Application of usability engineering to
medical device
EN 1041(2008) Information supplied by the manufacturer of medical devices
ISO 14971(2007) Medical devices -　Application of risk management to
medical devices
EN 980(2008) Symbols for use in the labeling of medical devices
ISO 9919(2009) Medical electrical equipment -- Particular requirements for
the basic safety and essential performance of pulse oximeter
equipment for medical use
EN 12470-4(2000) + Clinical thermometers - Part 4: Performance of electrical
A1(2009) thermometers for continuous measurement Incorporates
Amendment A1: 2009
EN ISO 10993-5(1995) Biological evaluation of medical devices - Part 5: Tests for
in vitro cytotoxicity
EN ISO 10993-1(1997) Biological Evaluation of Medical Devices - Part 1: Evaluation
and Testing Supersedes
ISO 14155-1(2003) Clinical investigation of medical devices for human subjects
- Part 1: General requirements
ISO 14155-2(2003) Clinical investigation of medical devices for human subjects
- Part 2: Clinical investigation plans
EN 60529(1991) + A1(2000) Degrees of protection provided by enclosures (IP Code)
1.5 GMDN Code

:
1.6 Human contact Information
:
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xxTCF-02
Essential Requirement
(name) (name)
(date) (date)
Co., Ltd.
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EC Directive 93/42/EEC Essential Requirements Checklist Arising from Revision 2007/47/EC
Company : OOOOOOO Co., Ltd. Product Name : OOOOOOOO Model Name :
Applied Standards,
Applicable Document location
Essential Requirements-Medical Devices Directive Procedures,
Y/N /reference
Justification
1. Documentation Concerning Safe Use
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 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 intended use constitute acceptable risks when weighed against the benefits Risk Management File
to the patient and are compatible with a high level of protection of health and safety (XXTCF10-2)
ISO14971:2007
Y
This shall include: IEC 60601-1:2005
Operator’s manual
- reducing, as far as possible, the risk of use error due to the ergonomic features
(UM-XX)
of the device and the environment in which the device is intended to be used
(design for patient safety), and Safety test report
- consideration of the technical knowledge, experience, education and training and (TR-XXX
where applicable the medical and physical conditions of intended users (design for
lay, professional, disabled or other users).
2. Documentation to interpretation and Construction
The solutions adopted by the manufacturer for the design and construction of the
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: ISO14971:2007 Risk Management File
Y
- eliminate or reduce risks as far as possible(inherently safe design and IEC 60601-1:2005
Operator’s manual
construction),
- where appropriate take adequate protection measures including alarms if
necessary, in relation to risks that cannot be eliminated,
- inform users of the residual risks due to any shortcomings of the protection
measures adopted.
IEC 60601-1:2005 Risk Management File
3. Specification of Function(s) Y
ISO14971:2007
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Applied Standards,
Y/N /reference
Justification
Safety test report
The devices must achieve the performance intended by manufacturer and be
designed, manufactured an packaged in such a way that they are suitable for one or Operator’s manual
more of the functions referred to in Article 1(2) (a) as specified by the manufacturer.
4. Maintenance of the Function(s) during Lifetime

The characteristics and performances referred to in sections 1,2 and 3 must not be IEC 60601-1:2005 Risk Management File
adversely affected to such a degree that the clinical condition and safety of the Y
patients and, where applicable, of other persons are compromised during the lifetime ISO14971:2007 Safety test report
of the device as indicated by the manufacturer, when the device is subjected to the
stresses which can occur during normal conditions of use.
5. Packaging, Transportation and Storage Risk Management File
The devices must be designed, manufactured and packaged in such a way that their IEC 60601-1:2005 Safety test report
characteristics and performances during their intended use will not be adversely Y
ISO14971:2007 Operator’s manual
affected during the transport and storage taking account of the instructions and
information provided by the manufacturer.
6. Performance Comparison of Intended and Undesirable Effects Risk Management File
Any undesirable side-effect must constitute an acceptable risk when weighed IEC 60601-1:2005 Safety test report
against the performances intended Y
ISO14971:2007 Clinical Evaluation
6a. Demonstration of conformity with the essential requirements must include a
clinical evaluation in accordance with Annex X. Report
7. Chemical, physical and biological properties
7.1 The devices must be designed and manufactured in such a way as to guarantee
the characteristics and performances referred to in Section I on the “General EN ISO 10993-1:1997 Bio-compatibility report
requirements”. Particular attention must be paid to:
ISO 14971:2007 Risk Management File
- The choice of materials used, particularly as regards toxicity and, where Y
appropriate, flammability; IEC 60601-1:2005 Safety test report
- 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 modeling research whose validity has
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Applied Standards,
Y/N /reference
Justification
been demonstrated beforehand.
7.2 The devices must be designed and manufactured in such a way as to minimize
the risk posed by contaminants and residues to the persons involved in the Not generate
transport, storage and use of the devices and to the patients, taking account of N contaminants and
the intended purpose of the product. Particular attention must be paid to the residues.
tissues exposed and the duration and frequency of the exposure.
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 contact during normal use or during routine procedures: if the devices are
Not used together
intended to administer medicinal products they must be designed and N
substances.
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.
7.4 Where a device incorporates, as an integral part, a substance which, if used
separately, may be considered to be a medicinal product as defined in Article 1 of
Not used to some
Directive 2001/83/EC and which is liable to act upon the body with action ancillary N
kind of substance.
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.
7,4 (continued) 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
Not used to some
accordance with Regulation (EC) No 726/2004 on the quality and safety of the N
kind of substance.
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.
7.4 (continued) Where a device incorporates, as an integral part, a human blood
derivative, 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 Not used to human
N
device, seek a scientific opinion from the EMEA, acting particularly through its blood derivative.
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.
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Applied Standards,
Y/N /reference
Justification
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.
7.4 (continued) Where changes are made to an ancillary substance incorporated in a
device, in particular related to its manufacturing process, the notified body shall be
informed of the changes and shall consult the relevant medicines competent Not applicable to
authority (i.e. the one involved in the initial consultation), in order to confirm that N
the quality and safety of the ancillary substance are maintained. The competent ancillary substance.
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,
7.4 (continued) When the relevant medicines competent authority (i.e. the one
involved in the initial consultation) has obtained information on the ancillary
substance, which could have an impact on the established benefit/risk profile of the
addition of the substance in the medical device, it shall provide the notified body Not used to some
N
with advice, whether this information has an impact on the established benefit/risk kind of substance.
profile of the addition of the substance in the medical device or not. The notified
body shall take the updated scientific opinion into account in reconsidering its
assessment of the conformity assessment procedure
7.5 The devices must be designed and manufactured in such a way as to 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 Not leaking to
N
reproduction, in accordance with Annex I to Council Directive 67/548/EEC of 27 June substances.
1967 on the approximation of laws, regulations and administrative provisions relating
to the classification, packaging and labelling of dangerous substances
7.5 (continued) 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 Not administer and/or
devices intended for transport and storage of such body fluids or substances, contain remove to medicines,
phthalates which are classified as carcinogenic, mutagenic or toxic to reproduction, N body liquids or other
of category 1 or 2, in accordance with Annex I to Directive 67/548/EEC, these devices substances to or
must be labelled on the device itself and/or on the packaging for each unit or, from the body.
where appropriate, on the sales packaging as a device containing phthalates.
7.5 (continued) If the intended use of such devices includes treatment of children or
treatment of pregnant or nursing women, the manufacturer must provide a specific Not treatment to
N
justification for the use of these substances with regard to compliance with the children or pregnant.
essential requirements, in particular of this paragraph, within the technical
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Applied Standards,
Y/N /reference
Justification
documentation and, within the instructions for use, information on residual risks for
these patient groups and, if applicable, on appropriate precautionary measures.
7.6 The devices must be designed and manufactured in such a way as to reduce as Risk Management File
much as possible, risks posed by the unintentional ingress of substances into the ISO 14971:2007
Y Safety test report
device taking int account the device and the nature of the environment in which it is IEC 60601-1:2005
intended to be used.
Risk Management File
8. Infections and microbial contamination

8.1 The devices and their manufacturing processes must be designed in such a way ISO 14971:2007 Safety test report
as to eliminate or reduce as far as possible the risk of infection to the patient, user Y
IEC 60601-1:2005
and third parties.The design must allow easy handling and, where necessary,
minimize of the device by the patient or vice versa during use. contamination Operator’s manual
8.2 Tissues of animal origin must originate e from animals that have been subjected
to veterinary controls and surveillance adapted to the intended use of the tissues.
Notified bodies shall retain information on the geographical origin of the animals.
Not used tissues of
Processing, preservation, testing and handling of tissues, cells and substances of N
animal.
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 and manufactured and
packed in a non-reusable pack and/or according to appropriate procedures to ensure
Not applicable
that they are sterile when placed on the market and remain sterile, under the N
sterilization.
storage and transport conditions laid down, until the protective packaging is damaged
or opened.
8.4 Devices delivered in a sterile state must have been manufactured and sterilized Not applicable
N
by an appropriate, validated method. sterilization.
8.5 Devices intended to be sterilized must be manufactured in appropriately Not applicable
N
controlled (e.g. environmental) conditions. sterilization.
8.6 Packaging systems for non-sterile devices must keep the product without N Not applicable
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Applied Standards,
Y/N /reference
Justification
deterioration in the level of cleanliness stipulated and, if the devices are to be
sterilized prior to use, minimize the risk of microbial contamination. The packaging
sterilization.
system must be suitable taking account of the method of sterilization indicated by
the manufacturer.
8.7 The packaging and/or label of the device must distinguish between identical or Not applicable
N
similar products sold in both sterile and non-sterile condition. sterilization.
9. Construction and environmental properties

9.1 If the device is intended for use in combination with other devices or equipment, ISO 14971:2007
the whole combination, including the connection system must be safe and must not Y Safety test report
IEC 60601-1:2005
impair the specified performance of the devices. Any restrictions on use must be Operator’s manual
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

minimize as far as possible:
- The risk of injury, in connection with their physical features, including the
volume/pressure ratio, dimensional and where appropriate ergonomic features.
-Risks connected with reasonably foreseeable environmental conditions, such as Y IEC 60601-1:2005 Safety test report
magnetic fields, external electrical influences, electrostatic discharge, pressure,
IEC 60601-1-2:2007 EMC test report
temperature or variations in pressure and acceleration.
-The risk of reciprocal interference with other devices normally used in the
investigations or for the treatment given.
- Risks arising where maintenance or calibration are not possible (as with
implants), from aging of 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 minimize the
risks of fire or explosion during normal use and in single fault condition. IEC 60601-1:2005 Safety test report
Y
Particular attention must be paid to devices whose intended use includes exposure ISO 14971:2007 Risk Management File
to flammable substance which could cause combustion.
- 20 -
Applied Standards,
Y/N /reference
Justification
10. Devices with a measuring function
10.1 Devices with a measuring function must be designed and manufactured in such IEC 60601-1:2005 Safety test report
a way as to provide sufficient accuracy and stability within appropriate limits of Y
accuracy and taking into account of the intended purpose of the device. The limits
of accuracy must be indicated by the manufacturer.
Safety test report
10.2 The measurement, monitoring and display scale must be designed in line with IEC 60601-1:2005
Y Risk Management File
ergonomic principles, taking account of the intended purpose of the device. ISO 14971:2007
Safety test report

10.3 The measurements made by devices with a measuring function must be IEC 60601-1:2005
expressed in legal units conforming to the provisions of Council Directive 80/181/EEC. ISO 14971:2007
11. Protection against radiation

11.1 General
Not generate
11.1.1 Devices shall be designed and manufactured such that exposure of patients, N
radiation.
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 Intended radiation
11.2.1 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 Not generate
N
risks inherent in the emission, it must be possible for the user to control the radiation.
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
Not generate
invisible radiation, they must be fitted, where practicable, with visual displays and/or N
radiation.
audible warnings of such emissions.
Not generate
11.3 Unintended radiation N
radiation.
- 21 -
Applied Standards,
Y/N /reference
Justification
11.3.1 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 reduced as far as possible
11.4 Instructions
11.4.1 The operating instructions for devices emitting radiation must give detailed Not generate
information as to the nature of the emitted radiation, means of protecting the N
radiation.
patient and the user and on ways of avoiding misuse and of eliminating the risks
inherent in installation
11.5 Ionizing radiation
11.5.1 Devices intended to emit ionizing radiation must be designed and Not generate ionizing
manufactured in such a way as to ensure that, where practicable, the quantity, N
radiation.
geometry and quality of radiation emitted can be varied and controlled taking into
account the intended use.
11.5.2 Devices emitting ionizing radiation intended for diagnostic radiology shall be
designed and manufactured in such a way as to achieve appropriate image and/or Not generate ionizing
N
output quality for the intended medical purpose whilst minimizing radiation radiation.
exposure of the patient and user.
11.5.3 Devices emitting ionizing radiation, intended for therapeutic radiology shall be
designed and manufactured in such a way as to enable reliable monitoring and Not generate ionizing
N
control of the delivered dose, the beam type and energy and where appropriate the radiation.
quality of radiation.
Safety test report
12 Requirements or medical devices connected to or equipped with an energy source
12.1 Devices incorporating electronic programmable systems must be designed to IEC 60601-1:2005
ensure the repeatability, reliability and performance of these systems according to Y Software validation
ISO 14971:2007
the intended use. In the event of a single fault condition (in the system) appropriate report
means should be adopted to eliminate or reduce as far as possible consequent risks.
Software development
12.1a For devices which incorporate software or which are medical software in process
themselves, the software must be validated according to the state of the art taking IEC 60601-1:2005
Y
into account the principles of development lifecycle, risk management, validation and ISO 14971:2007 Safety test report
verification.
- 22 -
Applied Standards,
Y/N /reference
Justification
Software validation
report
Safety test report

12.2 Devices where the safety of the patients depends on an internal power supply IEC 60601-1:2005
must be equipped with a means of determining the state of the power supply. ISO 14971:2007
Operator’s manual
Safety test report

12.3 Devices where the safety of the patients depends on an external power supply IEC 60601-1:2005
must include an alarm system to signal any power failure. ISO 14971:2007
Operator’s manual
EN 60601-1-8:2007
IEC 60601-1:2005 Safety test report

12.4 Devices intended to monitor one or more clinical parameters of a patient must
be equipped with appropriate alarm systems to alert the user of situations which Y ISO 14971:2007 Risk Management File
could lead to death or severe deterioration of the patient’s state of health.
EN 60601-1-8:2007 Operator’s manual
12.5 Devices must be designed and manufactured in such a way as to minimize the ISO 14971:2007 Risk Management File
risks of creating electromagnetic fields which could impair the operation of other Y
devices or equipment in the usual environment. IEC 60601-1-2:2007 EMC Test report
IEC 60601-1:2005
12.6 Protection against electrical risks Y
ISO 14971:2007 Safety test report
- 23 -
Applied Standards,
Y/N /reference
Justification
Devices must be designed and manufactured in such a way as to avoid, as far as Risk Management File
possible, the risk of accidental electric shocks during normal use and in single fault
condition, provided the devices are installed correctly.
12.7 Protection against mechanical and thermal risks Safety test report
IEC 60601-1:2005
12.7.1 Devices must be designed and manufactured in such a way as to protect the Y Risk Management File
patient and user against mechanical risks connected with, for example, resistance, ISO 14971:2007
stability and moving parts.
12.7.2 Devices must be designed and manufactured in such a way as to reduce to
the lowest possible level the risks arising from vibration generated by the devices,
Not generate to
taking account of technical progress and of the means available for limiting N
vibration.
vibrations, particularly at source, unless the vibrations are part of the specified
performance.
Safety test report
12.7.3 Devices must be designed and manufactured in such a way as to reduce to IEC 60601-1:2005
the lowest possible level the risks arising from the noise emitted, taking account of
Y
technical progress and of the means available to reduce noise, particularly at source,
unless the noise emitted is part of the specified performance. ISO 14971:2007 Risk Management File
12.7.4 Terminals and connectors to the electricity, gas or hydraulic and pneumatic IEC 60601-1:2005 Safety test report
energy supplies which the user has to handle must be designed and constructed in Y
such a way as to minimize all possible risks ISO 14971:2007 Risk Management File
12.7.5 Accessible parts of the devices (excluding the parts or areas intended to IEC 60601-1:2005 Safety test report
supply heat or reach given temperatures) and their surroundings must not attain Y
potentially dangerous temperatures under normal use. ISO 14971:2007 Risk Management File
12.8 Protection against the risks posed to the patient by energy supplies or
N
substances
- 24 -
Applied Standards,
Y/N /reference
Justification
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.
12.8.2 Devices must be fitted with the means of preventing and/or indicating any
inadequacies in the flow-rate, which could pose a danger.
Devices must incorporate suitable means to prevent, as far as possible, the N
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 N
or adjustment parameters by means of a visual system, such information must be
understandable to the user and, as appropriate, the patient.
13. Information supplied by the manufacturer
13.1 Each device must be accompanied by the information needed to use it safely
and properly, taking account of the training and knowledge of the potential users,
and to identify the manufacturer.
- This information comprises the details on the label and the data in the
instructions for use. Operator’s manual
- As far as practicable and appropriate, the information needed to use the device Y IEC 60601-1:2005 Product label
safely must be set out on the device itself and/or on the packaging for each unit
Packaging box drawing
or, where appropriate, on the sales packaging. If individual packaging of each unit
is not practicable, the information must be set out in the leaflet supplied with one
or more devices.
- Instructions for use must be included in the packaging for every device. By
way of exception, no such instructions for use are needed for devices in Class I or
IIa if they can be used safely without any such instructions
13.2 Where appropriate, this information should take the form of symbols. Any Operator’s manual
symbol or identification color used must conform to the harmonized standards. In
Y EN 1041:2008 Product label
areas for which no standards exist, the symbols and colors must be described in the
documentation supplied with the device
- 25 -
Applied Standards,
Y/N /reference
Justification
13.3. The label must bear the following particulars:
(a) the name or trade name and address of the manufacturer. For devices imported
into the Community, in view of their distribution in the Community, the label, or the Y EN 1041:2008 Product label
outer packaging, or instructions for use, shall contain in addition the name and
address of the authorized 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 the
Y EN 1041:2008 Packaging box drawing
packaging especially for the users;
Not sterilization
(c) where appropriate, the word ‘STERILE’; N
product.
(d) where appropriate, the batch code, preceded by the word ‘LOT’, or the serial
number;
(e) where appropriate, an indication of the date by which the device should be
N Not available period.
used, in safety, expressed as the year and month;
(f) where appropriate, an indication that the device is for single use. A Not single use
N
manufacturer's indication of single use must be consistent across the Community; product.
Not custom-made
(g) if the device is custom-made, the words ‘custom-made device’; N
device.
(h) if the device is intended for clinical investigations, the words ‘exclusively for Not exclusively for
N
clinical investigations’; clinical investigations.
Operator’s manual
(i) any special storage and/or handling conditions; Y EN 1041:2008
Product label
IEC 60601-1:2005 Operator’s manual
(j) any special operating instructions; Y
EN 1041:2008
(k) any warnings and/or precautions to take; Y
EN 1041:2008
(l) year of manufacture for active devices other than those covered by (e). This
indication may be included in the batch or serial number;
(n) in the case of a device within the meaning of Article 1(4a), an indication that the device Not contains a human
N
contains a human blood derivative. blood derivative.
13.4 If the intended purpose of the device is not obvious to the user, the manufacturer must Y IEC 60601-1:2005 Operator’s manual
- 26 -
Applied Standards,
Y/N /reference
Justification
clearly state it on the label and in the instructions for use EN1041:2008
13.5 Wherever reasonable and practicable, the devices and detachable components must be IEC 60601-1:2005
identified, where appropriate in terms of batches, to allow all appropriate action to detect any Y Product label
potential risk posed by the devices and detachable components EN1041:2008
13.6 Where appropriate, the instructions for use must contain the following particulars: Operator’s manual
Y IEC 60601-1:2005
(a) the details referred to in Section 13.3, with the exception of (d) and (e);
(b) the performances referred to in Section 3 and any undesirable side effects; Y IEC 60601-1:2005 Operator’s manual
Not installed with

(c) if the device must be installed with or connected to other medical devices or equipment in
or connected to other
order to operate as required for its intended purpose, sufficient details of its characteristics to N
medical devices or
identify the correct devices or equipment to use in order to obtain a safe combination;
equipment.
(d) all the information needed to verify whether the device is properly installed and can operate IEC 60601-1:2005 Operator’s manual
correctly and safely, plus details of the nature and frequency of the maintenance and calibration Y
needed to ensure that the devices operate properly and safely at all times; EN1041:2008
(e) where appropriate, information to avoid certain risks in connection with implantation of the Not implantation
N
device; product.
(f) information regarding the risks of reciprocal interference posed by the presence of the
Y IEC 60601-1-2:2007 Operator’s manual
device during specific investigations or treatment;
(g) the necessary instructions in the event of damage to the sterile packaging and, where Not sterilization
N
appropriate, details of appropriate methods of re-sterilization; product.
(h) if the device is reusable, information on the appropriate processes to allow reuse, including
cleaning, disinfection, packaging and, where appropriate, the method of sterilization of the device
to be re-sterilized, and any restriction on the number of reuses. IEC 60601-1:2005 Operator’s manual
Y
Where devices are supplied with the intention that they be sterilized before use, the EN1041:2008
instructions for cleaning and sterilization must be such that, if correctly followed, the device will
still comply with the requirements in Section I.
(h) (continued) If the device bears an indication that the device is for single use, information Not single use
N
on known characteristics and technical factors known to the manufacturer that could pose a risk product.
- 27 -
Applied Standards,
Y/N /reference
Justification
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 (for Operator’s manual
Y EN1041:2008
example, sterilization, final assembly, etc.);
(j) in the case of devices emitting radiation for medical purposes, details of the nature, type,
intensity and distribution of this radiation. The instructions for use must also include details
N Not radiation product.
allowing the medical staff to brief the patient on any contra-indications and any precautions to
be taken.
The instructions must also include details allowing the medical staff to brief the patient on any Not radiation
N
contraindications and any precautions to be taken. These details should cover in particular: product.
IEC 60601-2-XX Operator’s manual
(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 foreseeable environmental IEC 60601-2-XX Operator’s manual
conditions, to magnetic fields, external electrical influences, electrostatic discharge, pressure or Y
variations in pressure, acceleration, thermal ignition sources, etc.; EN1041:2008
(m) adequate information regarding the medicinal product or products which the device in Intended purpose is
question is designed to administer, including any limitations in the choice of substances to be N not delivered to any
delivered substances.
(n) precautions to be taken against any special, unusual risks related to the disposal of the Operator’s manual
Y IEC 60601-1:2005
device;
Not contain to
(o) medicinal substances, or human blood derivatives incorporated into the device as an medicinal substances
N
integral part in accordance with Section 7.4; or human blood
derivatives.
(p) degree of accuracy claimed for devices with a measuring function; Y
EN1041:2008
(q) date of issue or the latest revision of the instructions for use IEC 60601-1:2005 Operator’s manual
Y
NOTE : to be understand as “date of issue of the latest revision” EN1041:2008
- 28 -
xxTCF-03
Device Description
(name) (name)
(date) (date)
Co., Ltd.
- 29 -
3.1 Product Name
1) Name of Item:
2) Name of Model:
3) Introduction
:
4) Device Classification
- Classification: Class IIb
According to the Rule 9 of Classification Criteria, annex IX, MDD 2007/47/EC
5) Intended Use
3.2 Exterior and Structure
1) General outlook
2) Explanation on exterior
3) User interface
3.3 Block diagram
3.4 Drawing
3.5 Circuit Diagram
3.6 Technical Specification
3.7 How to use

:　See the attached user manual
3.8 Life Time
- 30 -
xxTCF-04
Key Component
(name) (name)
(date) (date)
Co., Ltd.
- 31 -
Component/ Manufacturer/ Type Technical Standard Mark(s) &
No./model data No./, Certificates
Part No. Trademark
No./ Edition of
conformity 1
- 32 -
xxTCF-05
Manufacturing and Quality

Control
(name) (name)
(date) (date)
Co., Ltd.
- 33 -
The production and inspection is followed by our documented procedures based on our
quality systems - ISO 13485 / Medical Device Directives / 07/47/EC
Management Inspection
No. Proce Phase Description Remarks
ss
Item Method Item Method
- 34 -
xxTCF-06
Test Reports
(name) (name)
(date) (date)
Co., Ltd.
- 35 -
All our products are inspected by lot according to our inspection instructions.　 Before
the first products are placed on the market, main materials or production process is
changed and, all the specified test items are inspected. Following is the sample report
tested by other laboratories.
No. Title Standard Testing Lab Report No. Date
- 36 -
xxTCF-07
Risk Analysis
(name) (name)
(date) (date)
Co., Ltd.
- 37 -
1 Scope
2 Terms and definitions
3 General requirements for risk management
3.1 Risk management process
3.2 Management responsibilities
3.3 Qualification of personnel
3.4 Risk management plan.
3.5 Risk management file
4 Risk analysis
4.1 Risk analysis process
4.2 Intended use and identification of characteristics related to the
safety of the medical device
4.3 Identification of hazards
4.4 Estimation of the risk(s) for each hazardous situation
5 Risk evaluation
6 Risk control
6.1 Risk reduction
6.2 Risk control option analysis
6.3 Implementation of risk control measure(s)
6.4 Residual risk evaluation
6.5 Risk/benefit analysis
6.6 Risks arising from risk control measures.
6.7 Completeness of risk control
7 Evaluation of overall residual risk acceptability
8 Risk management report
9 Production and post-production information
- 38 -
xxTCF-08
Labeling & Packaging
(name) (name)
(date) (date)
Co., Ltd.
- 39 -
8.1 Labeling for Unit Pack
8.1.1 Information label – Body
메인 라벨
No Symbols Description
S/N: The serial number of an object is a number on that
1
object which identifies it.
Manufacturer: Manufactures are goods or products which
2
have been made in a factory.
Date of Manufacture: a date that our product is
3
produced on.
4 NB Number
5 EC REP: The company who represents us in Europe.
6 TYPE BF APPLIED PART
7 General prohibition sign
8 Instruction for user manual
9 General warning, Caution
- 40 -
10 Dangerous voltage
Separate collection for WEEE-Waste of electrical and

11
electronic equipment.
8.1.2 Label for safety
Symbol / Label Description
8.2 Packaging
8.2.1 Packing List
1 Main body 1ea
- 41 -
7
8.2.2 Main Body Case 1ea, Hand-piece Bag 1ea
- 42 -
xxTCF-09
Clinical Evaluation Report
(name) (name)
(date) (date)
Co., Ltd.
- 43 -
1. General details
2. Description of the device and its intended application
3. Intended therapeutic and/or diagnostic indications and claims
4. Context of the evaluation and choice of clinical data types
5. Summary of the clinical data and appraisal
6. Data analysis
6.1 Performance
6.2 Safety
6.3 Product Literature and Instructions for Use
7. Conclusion
- 44 -
xxTCF-10
Software Validation Report
(name) (name)
(date) (date)
Co., Ltd.
- 45 -
1. LEVEL OF CONCERN
The INTRAcel software is intended for use in dermatological procedures.
The software does not control a life-supporting or life-sustaining device.
The software does not provide vital signs monitoring and alarms for
potentially life-threatening situations in which intervention is necessary.
The software does not provide diagnostic information on which
treatment or therapy is based.
The device software controls treatment delivery. However, any software
failures or latent design flaws would result in only a minor injury to the
patient or operator. Therefore, the INTRAcel software represents a
MODERATE level of concern. The risks associated with all hazards
identified by Jeisys were reduced to acceptable levels by the corrective
actions implemented.
Moderate. This device does not control a life supporting or life-sustaining
device, does not control the delivery of a potentially harmful energy, does
not control the delivery of treatment, does not provide diagnostic
information, and does not provide any vital signs monitoring. In addition,
the hazard analysis identifies those serious injury instances or life
threatening events and is mitigated through the risk assessment.
The software level of concern for the INTRAcel device is ClassB. The
rationale for the decision on the software level of concern is shown below
in the tables extracted from the Food and Drug Administration guidance
document.
Table A – Major Level of Concern Rationale
If the answer to any one question below is Yes, the Level of Concern for
the Software Device is likely to be Major.
Question Answer Rationale
1. Does the Software Device NO The device is not a Blood
qualify as Blood Establishment Establishment Computer Software.
Computer Software?
2. Is the Software Device NO The device is not intended to be
intended to be used in used in conjunction with a drug or
combination with a drug or biologic.
biologic?
3. Is the Software Device an NO The device is not an accessory to a
accessory to a medical device medical device that has a major
that has a Major Level of level of concern.
Concern?
4. Prior to mitigation of hazards, could a failure of the Software Device result
in death or serious injury, either to a patient or to a user of the device?
Examples of this include the following:
a. Does the Software Device NO The device does not control a life
control a life supporting or sustaining or life supporting
life sustaining function? function.
b. Does the Software Device NO The software does not control the
control the delivery of delivery of potentially harmful
potentially harmful energy
- 46 -
that could result in death or energy that could result in a death
serious injury, such as or serious injury.
radiation treatment systems,
defibrillators, and ablation
generators?
c. Does the Software Device NO The device does not control the
control the delivery of delivery of treatment or therapy
treatment or therapy such such that an error or malfunction
that an error or malfunction could result in death or serious
could result in death or injury.
serious injury?
d. Does the Software Device NO The software device processes
provide diagnostic information (displays) digital information for the
that directly drives a decision assessment of treatment only. This
regarding treatment or information does not directly
therapy, such that if mandate or control a decision
misapplied it could result in regarding treatment or therapy as
serious injury or death? all digital information must be
interpreted by a competent medical
person together with any additional
clinical information required for
treatment.
e. Does the Software Device NO The device does not provide any
provide vital signs monitoring vital signs monitoring and/or
and alarms for potentially life alarms.
threatening situations in
which medical intervention is
necessary?
Table B – Moderate Level of Concern Rationale
If the answer to any one question below is Yes, the Level of Concern for
the Software Device is likely to be Moderate.
Question Answer Rationale
1. Is the Software Device an YES The device is not an accessory
accessory to a medical device to a medical device that has a
that has a Moderate Level of moderate level of concern.
Concern?
2. Prior to mitigation of hazards, YES A failure of the software device
could a failure of the Software would result in Minor Injury,
Device result in Minor Injury, either to a patient or to a user
either to a patient or to a user of the device if mitigation of
of the device? hazards were not implemented.
3. Could a malfunction of, or a NO A malfunction or a latent
latent design flaw in, the design flaw in the software
Software Device lead to an device would not lead to an
erroneous diagnosis or a delay in erroneous diagnosis as the
delivery of appropriate medical device is not intended to
diagnosis a condition.
- 47 -
care that would likely lead to
Minor Injury?
* Attachment
000_Software MINUTES
001_Software Validation plan
002_Software Requiremnet Specification
003_Software Design Specification
004_Software Risk Management
005_Software Valdiation Report
006_VVT
- 48 -
xxTCF-11
Biological Safety Assessment

Report
(name) (name)
(date) (date)
Co., Ltd.
- 49 -
1. Introduction
This is report that confirmation biocompatibility availability of product according to
connection regulation such as examination of toxicity, examination for skin
stimulus and danger analysis.
The toxicity of a compound or material is investigated using basic toxicology
studies which provide information on the nature of toxic effects elicited by a test
material, dosages at which the effects occur and the no-effect levels. Since all
chemical compounds are toxic at some level of exposure, if follows that a
toxicological hazard exists for all medical devices, the material from which they
are made and all ingredients, additive and processing aids associated with those
material.
Where available, a summary of experience from clinical use of material should be
documented. This should include detail of the nature of patient contact, the
number of device used, the period of time for which they have been used and
the number and nature of adverse reactions. For novel material, this information
may be necessary for each ingredient.
Where the mode of patient contact or the chemical or physical nature of the
established material is not identical to that in the intended application, the
differences should be identified and an assessment of their significance
documented. Where relevant, the result of clinical investigations which address
biological safety should be included.
2. Description for Device

2.1 Intended Use
2.2 Overall Description
2.3 External Appearance of device
3. Reference
(1) EN ISO 14971(2012): Medical devices – Application of risk management to

medical device
(2) Guidance on bio-compatibility assessment EC medical devices directive
(3) EN ISO10993-1(2009): Biological evaluation of medical devices – Part 1:

Evaluation and testing within a risk management process
- 50 -
Tests for in vitro cytotoxicity

Tests for irritation and skin sensitization.
4. Materials Analysis
4.1 Analysis of the materials contacting the Human body
While using the product, you may be contacted by the parts shown in the table
below. Such parts contacting the human body have been verified of their
safety by toxicity tests as follows;
Cytotoxicity Test(EN ISO 10993-5), Intracutaneous Reactivity Test(ISO 10993-10),

Maximization Sensitization Test(ISO 10993-10)
[Table 1 – Human body contact parts]
Human Raw Test Item Test Date of Test Result Laboratory

Contact Material Report Issue
Part Number
Cytotoxicity Non
Cytotoxicity
Intracutaneou Non
s Reactivity
Irritation
Maximization Do not
Sensitization show any
delayed
sensitizatio
n
4.2 Data Analysis
In order to evaluate the bio-compatibility of our products, we have conduced

bio-compatibility study on the raw material of our products by using Figure 1
and Table 1 Presented in EN ISO 10993-1:2009. The raw materials used for our
product are not the ones that have been newly developed of the ones that
- 51 -
have not been ever used till now. They have been used in medical field for a
long time. The most of raw materials used by us have been verified of their
safety. However a series of tests has been performed in accordance with the
table 1[Test Route: Category-Surface, Contact-Skin, Contact Duration
–A(Limited(24h))]. Annex A, ISO10993-1 since there is little study on the toxicity
involved in the case that such materials are mixed According to the Test
Route, Table 1, Annex A, ISO10993-1, our product should take Cytotoxicity test,
Intracutaneous Reactivity Test, Sensitization test.
[Flow Chart 1 – Summary of the systematic approach to a biological

evaluation of medical devices as part of a risk management process]
[Table 1 – Evaluation tests for consideration (EN ISO10993-1:2009 Annex a)]
- 52 -
- 53 -
5. Conclusion
We have investigated the conformity of every material used for this

product by biologically checking and analyzing various stimulation of the
product materials reacted by human body.
Based on much information and data of the materials used for this
product. We have evaluated the medical conformity with Biocompatibility
Test Report of the materials, We have proven that the materials do not
have any harmful effect on human body.
In conclusion, the materials of this product have been recognized to be

compatible enough for you to use this product safety without any problem
onto user`s human body and do not make any harm.
- 54 -
xxTCF-12
Usability engineering file
(name) (name)
(date) (date)
Co., Ltd.
- 55 -
1. Introduction to the sample USABILITY SPECIFICATION
2. Inputs to the USABILITY SPECIFICATION
2.1 Specification of the INTENDED USE / INTENDED PURPOSE
2.2 PRIMARY OPERATING FUNCTION
2.3 Risk analysis
3. USABILITY SPECIFICATION and VERIFICATION
3.1 General
4. USABILITY VALIDATION
4.1 General
4.2 Plan
4.3 Plan
- 56 -
xxTCF-13
Post Market Follow-up
(name) (name)
(date) (date)
Co., Ltd.
- 57 -
1. PURPOSE
The purpose of this procedure is to provide for a system and
instructions, and to assign responsibilities for gathering and
analyzing post-production feedback and for meeting customer
requirements.
2. APPLICATION
This procedure applies to products, delivery, and other activities
bearing on post-production feedback.
3. PROCEDURE
3.1 Customer feedback system
3.2 Self-monitored feedback
4. ASSOCIATED DOCUMENTS
5. ASSOCIATED RECORDS
- 58 -
xxTCF-14
EC Declaration of Conformity
(name) (name)
(date) (date)
Co., Ltd.
- 59 -
Declaration of Conformity
according to the Medical Devices Directive 93/42/EEC as amended by Directive 2007/47/EC
Manufacturer:
Address
European Representative:
Address
Product :
Brand name:
Classification :
GMDN Code:
The product identified above complies with the essential requirements of the above EC
Directives by meeting the following standards:
This Declaration of Conformity is based on the EC Directives 93/42/EEC, Annex II (Excluding Section 4) under
the supervision of Notified body
Notified body:
EC Certificate No.: Issue date: / Valid until:
Place: Date:
- 60 -
참고문헌
- 61 -
터키 의료기기 제품 인증 절차 – 기술문서예시
발행연월 : 2019년 7월
발 행 처 : 식품의약품안전처 식품의약품안전평가원
우) 28159 충북 청주시 흥덕구 오송읍 오송생명 2로 187
문 의 처 : 정책연구팀 (Tel. 02-860-4342~4344)
- 62 -

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3-1. CE기술문서 예시 ···································································· 3

Development Team Manager R&D Manager

Development Team Manager R&D Manager

File No. Title Rev. No Date

xxTCF-00 Table of Contents 0

xxTCF-01 General Information 0

Compliance Checklist of Essential

Device Description (Attach: User

xxTCF-04 Key Component 0

xxTCF-05 Manufacturing and Quality Control 0

xxTCF-06 Test Reports (Attach: Test Report) 0

xxTCF-07 Risk Analysis 0

xxTCF-08 Labeling & Packaging 0

xxTCF-09 Clinical Evaluation Report 0

xxTCF-10 Software Validation Report 0

xxTCF-11 Biological Safety Assessment Report 0

xxTCF-12 Usability engineering file 0

xxTCF-13 Post Market Follow-up 0

xxTCF-14 EC Declaration of Conformity 0

Development Team Manager R&D Manager

This Technical Construction File consists of technical documentation related to

1.2 Class of Product

Any medical device the operation of which depends on a source of electrical

▪ Medical Device Class: IIb

Medical Device Class is determined by the standard for classification as below.

Standard for classification class A or N/A

All non-invasive devices are in Class I, unless one of I N/A

- in all other cases they are in Class I. I N/A

- All non-invasive devices intended for modifying the IIb N/A

- unless the treatment consists of filtration, centrifugation IIa N/A

All non-invasive devices which come into contact with I N/A

- are in Class IIa in all other cases, including devices

- intended specifically to diagnose, monitor or correct a

- reusable surgical instruments, in which case they are in

- intended to supply energy in the form of ionizing IIb N/A

- intended to have a biological effect or to be wholly or

- intended to administer medicines by means of a

- either specifically to diagnose, monitor or correct a

- or to supply energy in the form of ionizing radiation in IIb N/A

- or to have a biological effect or to be wholly or mainly III N/A

- or to undergo chemical change in the body, except if

- to be placed in the teeth, in which case they are in

- or to undergo chemical change in the body, except if III N/A

- unless their characteristics are such that they may

- if they are intended to supply energy which will be IIa N/A

- if they are intended to image in vivo distribution of IIa N/A

- that is potentially hazardous, taking account of the IIb N/A

All other active devices are in Class I. I N/A

- unless they are implantable or long term invasive III N/A

All devices intended specifically to be used for disinfecting IIa N/A

▪ Classification Result Summary

Applicable Rule Number Classification

1.4 Applicable normative references

Collateral Standard: Electromagnetic compatibility –

1.5 GMDN Code

Development Team Manager R&D Manager

4. Maintenance of the Function(s) during Lifetime

8. Infections and microbial contamination

9. Construction and environmental properties

9.2 Devices must be designed and manufactured in such a way as to remove or

Safety test report