PPM 2006~2007

, PPMCE New and Global Approach CE CE CE CE ISO 13485:2003 FDANRTLCCC SFDA (Essential Requirement)

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PPM -

ISO 9001:2000 ISO 13485:2003 -

CE(CPD) Initial type testing (ITT)- To determine the performance of the product typeFactory production control (FPC)- The permanent internal control of production exercised by the Certification Body to assure that all products conform to ITT

ManufacturerCertification BodyProcessApplicationPreparation of ContractContractPreparation of type testing sampleReceipt SampleSample PreparationModification of sample in case of test failureInitial Type TestingApplication of factory inspectionFactory inspection by authorized auditorFactory Production ControlReceipt CertificateSend CertificateIssue of CertificateSurveillancetype-testing by certification body and approved laboratory CE(CPD)

2. CE

CE - CE European Conformity Conformit Europene .

EC Mark 1993 93/68/EEC "CE Marking" . "CE Marking" .

CE (Directive )

(98/37/EC) (88/378/EEC) (89/106/EEC) (EMC - 89/336/EEC, LVD - 73/23/EEC, 96/57/EC, 92/75/EEC) (89/686/EEC) (93/42/EEC) (90/385/EEC) (98/79/EC) (97/23/EC)

CE (Directive ) (R&TTE) (1999/5/EC) (87/404/EEC) (90/396/EEC) (95/16/EC) Recreational craft (94/25/EC) Equipment and protective systems for use in explosive atmospheres (94/9/EC) Non-automatic weighing instruments (90/384/EEC) Cableways (2000/9/EC) Explosives for civil use (93/15/EEC) Hot water boilers (92/42/EEC)

CE For examples:

Chemicals () Pharmaceuticals () Cosmetics () Foodstuffs ()

CE

CE , .

CE CE .

CE

28

.

CE The CE marking is mandatory and must be affixed on any selected product before its placing on the single EU market

The CE marking must take the form according to picture below. If the CE marking is reduced or enlarged the proportions must be respected.

CE The CE marking must be affixed visibly, legibly and indelibly to the product or to its data label. A minimum height of the CE marking is required 5 mm.

If according to the applicable directives is involved Notified Body participation in the production control phase, must affix its identification number near CE marking.

The main goal of the New Approach directives is to assure that products which freely circulate in the EU market have a proper level of safety.

Principle responsibility of manufacturers in the field conformance with requirements of applied directives.

Market surveillance is a necessary element to correctly implement the above mentioned principles.

Rules of the market surveillance are particular in individual EU member states.

The member state must provide by means of National authorities the necessary legal and administrative implement to assure the compliance of the products on the market with the directives.

National authorities are responsible for ensuring the implementation of a proper market surveillance mechanism.

For communication between National authorities has been installed database RAPEX. RAPEX - a rapid exchange of information about dangers consumer products.

Actors for checking of product compliance with the New Approach directives:

The manufacturer checks product before its launching (placing) on the marketThe customs official checks products at the origin import from outside the EUThe market surveillance authority checks products during its live in the marketThe court, checks products when an incident occurs

CE CE marking

CE marking is NOT quality mark! Its principles and obligations for manufacturers arises from New Approach directives.

CE marking bears only on the European health, safety and environmental protection legislation

CE Quality marksFor quality marks the important rule is valid system is voluntary and is not dependent on EU legislative. Details are very good inscribed in standard ISO/IEC 17030

Quality marks system according to ISO/IEC 17030 has included beyond fulfilling of the legislation safety requirements also fulfilling of quality requirements.

Certification body makes periodic supervision of quality control system of the manufacturer production

The main objects and bodies involved intoproducts conformity assessment in EU3. New and Global Approach to technical harmonization

EU market 2005

Harmonised sphere

Products that are harmonised at Community level (30 % goods in EU):a) there are common EU technical rules (Old and New Approach Directives)

b) selected products must have the CE mark affixed

Old and New Approach Both are ways to harmonize the national requirements on products with aim to support free trade of goodsthe Old Approach has been leftthe New Approach is possible solutionat present, the discussions about amendment of it are going (New New Approach) differences of New and Old Approach: Old approach - to estimate parameters, limits, methods in lawNew Approach - to estimate basic essential requirements only

(Harmonized standards) PRODUCTConformity to directive hENEssential RequirementsAnother means of conformity evidence (approved by NB) ( )With or without NB assistance

Global ApproachNew Approach .

Global Approach .

Significance of the Global Approach is in establishing of uniform testing of products and other procedures for CE marked productsGlobal Approach CE .

Global Approach GLOBLN PSTUP

mutualconfidence

transparency of procedures

accreditationmanufacturers responsibility

Global Approach

quality systems

Exclusive responsibility for product safety (even in case NB activity)Most of the products assessed in module based on sole manufacturers responsibility (Module A)Quality system and Factory production control are cornerstones of all proceduresOnly manufacturer has the right to choice the proper procedure, if the alternatives are given by directiveManufacturer signs EC Conformity DeclarationManufacturer affixes the CE mark

Quality system is key aspect of manufactureAll Modules are based on the establishing and maintaining of quality system in productionIn the product with higher risks, the Modules with higher demand on quality system and its surveillance applyIn many directives the Full Quality Assurance is applicable as alternative to other ModulesMain tasks of Notified Bodies in highly hazardous product is production surveillance

Non - harmonized sphere 70%

a) There are no specific EU or national technical rules (no EU directives) related to product. Common requirements for products at the EU level does not exist.

OR

b) There are different and specific national technical rules. Member states may have their own regulations, taking into account the principles of free movement of goods.

Variety of conformity assessment procedures 4.

Modular system is based on two principles of Conformity assessments

on the intervention of a first party (manufacturer)

OR

on the intervention of a neutral (third) party(notified body)

the product design phase ORthe product manufacturing phase ORboth above mentioned phases at the same time

Every module specifies the obligations of the manufacturer and, if applicable, of the notified body. An overview of the modules shows the necessary complimentarity between the two phases of conformity assessment in the design phase and in the manufacturing phase of the product.

Modules (A to H) Module A Internal production controlModule B EC type examinationModule C Conformity to type (supplement to B)Module D Production quality assurance (suppl. to B)Module E Product quality assurance (suppl. to B)Module F Product verification (supplement to B)Module G Unit verificationModule H Full quality assurance

Modules description (A, B) Module A - Internal production controlInternal production control provides for an internal design and production control. This module does not require any involvement of a notified body.

Module B - EC Type Examination EC Type Examination is applied to the product design phase and must be complemented by a module that provides for an assessment of the production phase.The EC type examination certificate is issued by a notified body.

Modules description (C)

Module C - Conformity to Type Conformity to Type is applied to the production phase and follows upon Module B. It ensures that the product corresponds to the type, as it is described in the EC type examination certificate, issued in accordance with Module B. There is no need to involve a notified body for this module.

Modules description (D)

Module D - Production Quality Assurance Production Quality Assurance is applied during the production phase and follows upon Module B. It is based on the quality assurance standard ISO 9001 (but it is not identical) and involves intervention by a notified body that is responsible for approving and monitoring the quality assurance system established by the manufacturer, applicable to production, final acceptance and testing.

Modules description (E, F) Module E - Product Quality AssuranceProduct Quality Assurance Is applied during the production phase and follows upon Module B. It is based on quality assurance standard EN ISO 9001 and involves intervention by a notified body that is responsible for approving and monitoring the quality assurance system established by the manufacturer, applicable to final acceptance and testing.Module F - Product VerificationIs applied during the production phase and follows upon Module B. A notified body checks the conformity to type, as it is described in the EC type examination certificate, issued in accordance with Module B, and issues a certificate of conformity.

Modules description (G,H) Module G - Unit VerificationIs applied during the design and production phase. Every product is examined by a notified body, which issues a certificate of conformity.

Module H - Full Quality Assurance Is applied during the design and production phase. It is based on quality assurance standard EN ISO 9001 and involves a notified body that is responsible for approving and monitoring the quality assurance system established by the manufacturer, applicable to design, production, final acceptance and testing.

Note: The ISO 9001 Certificate is not satisfactory document for modules D, E, G, H.

5.

IntroductionNon harmonized sphere creates approximately 70 % goods in EU. Non harmonized sphere is very interesting area for development of different procedures with participation of the third - party Voluntary procedures in the EU states inspection, certification, granting of the mark Mark affixed on the product gives to consumers information about added value of goods and focuses attention to its differences.

Important and famous EU marksEU eco-labelling the 'Flower' mark

EU eco-labelling 'Flower' markAim - to award a Community Eco-label to products and services with reduced environmental impacts.

The scheme is VOLUNTARY.

Criteria are established for individual product groups, (the total number of product categories covered by the scheme was in year 2004 about 30 )

Certification Bodys MarksITC certified quality mark Safe toys mark

Certification Body own quality Mark

ITC certified quality mark is applicable to affixing on product, documents and publication where indicates conformity with specific requirements.

Rules are in the accordance with ISO/IEC 17030 (Conformity assessment General requirements for third-party marks of conformity)

6. CE

Scope of LVD directive 73/23/EECAs regard to LVD directive, it relates to all electrical equipment designed for use with a voltage rating between 50 V and 1000 V of the alternating current (AC) or between 75 V and 1500 V of the direct current (DC). Therefore the battery operated electrical instruments are not covered by this directive in majority of cases. In addition, the following equipments are excluded from the force of LVD (as they are covered by other more specific directives taking also into account the electrical safety):

for use in the explosive atmospherefor medical usefor liftselectricity metersplugs and socket outlets for domestic useelectric fencesspecialized equipment used in ships, aircrafts and railways (as they are subject of specific legislation)radio-electrical interference.

CE Examples are the radio and TV sets powered from electricity distribution network, electromotors and any instruments driven by electromotors, transformers, electrical fuses, capacitors, resistors and another electrical parts, switches, dimmers, power supplies, battery chargers, household home appliances (like vacuum cleaners, washing machines, steam irons, dryers, hair dryers, electric cookers), lights, electrical hobby tools, industrial equipment powered by electricity and their driving and controlling units, computers, printers, measuring instruments, etc. For the LVD is typical, that obligation of conformity assessment relates both to parts (as semiconductor parts or capacitors) and to complete assembled product (as a TV set). It is necessary to prevent confusion by CE marking of parts and products.

EMC directive relates to any electrical and electronic equipment (including electronic components), liable to cause electromagnetic disturbances (sources of disturbance) or performance of which is liable to be affected by such disturbance (products sensitive to disturbance or electromagnetic interference). As no voltage limit is applied; the battery operated equipments are also objects of the EMC directive. Excluded is military equipment. Practically each common electric and/or electronic appliance (including individual electronic components) shall be evaluated from viewpoint of EMC. In addition to this, the products powered by voltage higher than 50 V (AC) / 75 V (DC) shall be assessed for compliance to LVD (electrical safety).

7. CE

PPE is defined as any device or appliance designed to be worn or held for protection against one or more safety and health hazards.

Directive does not differentiate between PPE used for work activities and for leisure. All protective equipment is required to comply, whether it is intended for use at work or in the home, even at sporting activities.

Responsibility for deciding if a product is PPE or not rests with the manufacturer (or his authorized representative).

Simple PPE Category I Article 8.3 of the Directive defines the PPE of simple design exclusively as the PPE intended to protect the wearer against:

mechanical action whose effects are superficial (gardening gloves, thimbles etc.); cleaning materials of weak action and easily reversible effects (gloves affording protection against diluted detergents, aprons etc.); risks encountered in the handling of hot components which do not expose the user to a temperature exceeding 50 degrees C, or to dangerous impacts (gloves, aprons for professional use etc.); atmospheric agents of a neither exceptional nor extreme nature (headgear, seasonal clothing, footwear etc.);minor impacts and vibrations etc. which do not affect vital areas of the body and whose effects cannot cause irreversible lesions (light anti-scalping helmets, gloves, light footwear etc.); sunlight (sunglasses).

PPE, neither simple nor complex Category IIThe equipment in categories I and III are listed in the Directive. These lists are comprehensive and items which do not clearly fall within the descriptions of one list or the other must be either Category II PPE, or not PPE at all. Similar and exchangeable equipment not included in the scope of the PPE Directive: protective equipment for military use; protective equipment for self-defense; protective equipment for use by consumers to protect against: moisture, heat, certain weather conditions protective equipment intended for rescue activities on board ship or aircraft

Complex PPE - Category III Article 8.4(a) of the Directive defines the PPE of complex design as the PPEs intended to protect against mortal danger, or against dangers that may seriously and irreversibly harm the health of an individual, the immediate effects of which cannot be identified in sufficient time. This category III covers exclusively: filtering respiratory devices for protection against solid and liquid aerosols or irritant, dangerous, toxic or radio-toxic gases;respiratory protection devices providing full insulation from the atmosphere, including those for use in diving;PPE providing only limited protection against chemical attack or against ionizing radiation; emergency equipment for use in high-temperature environments, the effects of which are comparable to those of an air temperature of 100 degrees C or more and which may or may not be characterized by the presence of infra-red radiation, flames or the projection of large amounts of molten material;emergency equipment for use in low-temperature environments the effects of which are comparable to those of an air temperature of -50 degrees C or less; PPE to protect against falls from a height; PPE to protect against electrical risks and dangerous voltages or that used as insulation in high-tension work.

8. CE

Scope of the In-Vitro Diagnostics DirectiveIVD relates to medical devices for in vitro diagnostics and their accessories. Each medical appliance that is: Reagent/reactive product/calibration material/control material/kit/instrument device/or a system

In vitro investigation of specimens originating from the human body (saliva, perspiration, excrements, blood, tissue samples) with the aim to provide information:concerning a physiological or pathological stateconcerning a congenital (inherited) abnormalityto determine the safety and compatibility with potential recipientsto monitor therapeutic processes.In addition, specimen receptacles (containers for in-vitro tested samples) are IVD. Excluded from the scope of IVD are:products for general laboratory use, provided that the manufacturer did not appointed those products as specialised for In-vitro testinginvasive sampling devices for collecting samples for In-vitro diagnosticIVD devices produced and used in the same institution, without any transport or sale to other bodies

Classification of IVDThe Directive recognises 4 categories of IVDs. The level of regulatory control applied to an IVD is proportional to the degree of risk connected with the IVD application.In following indents, the categories of IVD are ordered according to increasing risk level:General IVDsIVDs for self testing, i.e. test kits used in a home environment (excluding self test devices covered by Annex II)IVDs in Annex II, List B of the Directive, e.g. test kits for rubella, Chlamydia, CMV, PSA, or the major tissue typing groupsIVDs in Annex II List A of the Directive, e.g. test kits for HIV, hepatitis B, C, or D, HTLV and the major blood groups.

IVD List A & BLists A and B in the Annex II are in detail described in following articles

List Areagents, related calibrators and control materials, for determining the following blood groups: ABO system / rhesus (C, c, D, E, e) / anti-Kell,reagents, related calibrators and control materials, for the detection, confirmation and quantification in human specimens of markers of HIV infection (HIV 1 and 2)HTLV I and IIand hepatitis B, C and D.

List BIVD for determining the following blood groups: anti-Duffy and anti-KiddIVD for determining irregular anti-erythrocytic antibodiesIVD for the detection of the congenital infections: rubella, toxoplasmosisIVD for diagnosing of phenylketonuriaIVD for determining infections by cytomegalovirus ChlamydiaIVD for determining the HLA tissue groups: DR, A, BIVD for detection tumoral marker PSAIVD for evaluating the risk of trisomy 21IVD for self-diagnosis of blood sugar content

Conformity assessment of IVD GeneralIVD that are not covered by Annex II and that are not the IVD devices for self testing nor performance evaluation: the manufacturer follows the procedure of Annex III (excluding point 6)draws up the EC declaration of conformityand affix the CE marking before placing the IVD on the market

Conformity assessment of IVD for self-testing Manufacturer shall, prior to the drawing up of the declaration of conformity, fulfil the supplementary requirements set out in Annex III, point 6. Instead of applying this procedure, the manufacturer may follow the procedure referred to in paragraphs 2 or 3.the manufacturer follows the procedure of Annex III (including point 6)draws up the EC declaration of conformityand affix the CE marking before placing the IVD on the marketor the manufacturer could follow the procedure of Annex IVor the manufacturer could apply the combined procedures of Annex V + Annex VI or Annex V + Annex VII

93/42/EEC 3 I . .

II. Clause 1 ~ 6

II. 7. , 8. 9. 10. 11. 12. 13. 14. (6) , X (Annex X) .

93/42/EEC 9

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1. 1) (Contact duration) (60 ), (60 30 ), (30 ) 2) (Active medical device) 3) (Invasive medical device)

2. 1) : Rule 1 ~ 4 2) : Rule 5 ~ 8 3) : Rule 9 ~12 4) : Rule 13 ~ 18

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(Conformity assessment procedures)Annex II : , Annex III : EC type examinationAnnex IV : EC verification Annex V : Annex VI : Annex VII : EC ( )Sect. 4 : Design examination

EC certificate .

- EC Design-Examination Certificate (Annex II section 4 MDD; Annex 2 section 4 AIMD)

- EC Type Examination Certificate (Annex III MDD; Annex 3 AIMD)

- Full Quality Assurance System Approval Certificate (Annex II section 3 MDD; Annex 2 section 3 AIMD)

- EC Verification Certificate (Annex IV MDD; Annex 4 AIMD)

- Production Quality Assurance System Approval Certificate (Annex V MDD; Annex 5 AIMD)

- Product Quality Assurance System Approval Certificate (Annex VI MDD)

93/42/EEC 17

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93/42/EEC 15

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Device Master File Design File QM documents QM records EC Declaration of conformance Checklist of the Essential requirements Reference to specific documents Description of the device Copy of issued Certificate by Notified Body Labels and instructions for use CE

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Class III Class III , Class III 510(k) Class III , Class III

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Class III 510(k) PMA 510(k) , , GMP (Preclinical Laboratory Testing Data) - , , - (Animal Testing Data) - , , (Human Clinical Testing Data)

NRTL ? (Department of Labor) (OSHA; Occupational Safety & Health Administration) (workplace)

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UL (Underwriters Laboratory)

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UL NRTL UL? & NRTL?

OHSA NRTL 19

1ARLApplied Research Laboratories, Inc.2CSACanadian Standards Association3CCLCommunication Certification Laboratory, Inc.4CSLCurtis-Straus LLC5DTLDetroit Testing Laboratory, Inc.6ETIElectro-Test, Inc7ENTEntela, Inc.8FMGTFM Global Technologies LLC9ITSNAIntertek Testing Services NA, Inc.10METMET Laboratories, Inc.11NSFNSF International12NTSNational Technical Systems, Inc. 13USTCU. S. Testing Company, Inc. 14SWRISouthwest Research Institute15TUVAMTUV America, Inc.16TUVPSGTUV Product Services GmbH17TUVTUV Rheinland of North America, Inc.18ULUnderwriters Laboratories Inc.19WLWyle Laboratories

, WTO " " . WTO 2002.5.1 CCC(China Compulsory Certification, ) . CCC

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13485 ? CE ISO 13485 ? ISO 13485 ? 3-4 ISO 13485 ? ISO 13485 ? ? 1 . ISO 13485 2 ISO 13485 ?

ISO 17025 ?

CE CE ? ? CE ? ? CE CE ? CE ?

. . CE ISO 13485 ? . CE ? 60~70 ? ? CE ? COCDOC?

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