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1、BRITISH STANDARD BS EN 50103:1996 Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for the active (including active implantable) medical device industry The European Standard EN 50103:1995 has the status of a British Standard ICS 03.120.10; 11.040.00 Licensed Copy: s
2、heffieldun sheffieldun, na, Mon Nov 06 02:03:04 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 50103:1996 This British Standard, having been prepared under the direction of the Health and Environment Sector Board, was published under the authority of the Standards Board and comes into effect on 15
3、 March 1996 BSI 01-2000 The following BSI references relate to the work on this standard: Committee reference CH/66 Draft for comment 92/52897 DC ISBN 0 580 25389 9 Committees responsible for this British Standard The preparation of this British Standard was entrusted to Technical Committee CH/66, Q
4、uality systems for the manufacture of medical devices, upon which the following bodies were represented: Association of British Certification Bodies Association of British Health-care Industries Association of Contact Lens Manufacturers Association of X-ray Equipment Manufacturers (BEAMA Ltd.) Briti
5、sh Anaesthetic and Respiratory Equipment Manufacturers Association British In Vitro Diagnostics Association British Orthopaedic Association British Surgical Trades Association Dental Laboratories Association Ltd. Department of Health Electro Medical Trade Association Ltd. GAMBICA (BEAMA Ltd.) Guild
6、of Hospital Pharmacists Institute of Physical Sciences in Medicine (IPSM) Institute of Quality Assurance Medical Sterile Products Association Surgical Dressings Manufacturers Association Amendments issued since publication Amd. No.DateComments Licensed Copy: sheffieldun sheffieldun, na, Mon Nov 06 0
7、2:03:04 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 50103:1996 BSI 01-2000i Contents Page Committees responsibleInside front cover National forewordii Foreword2 Text of EN 501033 List of referencesInside back cover Licensed Copy: sheffieldun sheffieldun, na, Mon Nov 06 02:03:04 GMT+00:00 2006,
8、Uncontrolled Copy, (c) BSI BS EN 50103:1996 ii BSI 01-2000 National foreword This British Standard has been prepared by Technical Committee CH/66 and is the English language version of EN 50103 Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for the active (includin
9、g active implantable) medical device industry, published by the European Committee for Electrotechnical Standardization (CENELEC). BS EN 50103 provides guidance on the operation of quality management systems used in the manufacture of active medical devices, as well as active implantable medical dev
10、ices. A similar standard, BS EN 724, covers guidance for the manufacture of non-active medical devices. In addition another standard, BS EN 928, which will provide guidance on quality management systems used in the manufacture of in vitro diagnostic devices, is in preparation. A British Standard doe
11、s not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Cross-references Publication referred toCorresponding British S
12、tandard ISO 9001:1987aBS EN ISO 9001:1994 Quality systems. Model for quality assurance in design, development, production, installation and servicing ISO 9002:1987bBS EN ISO 9002:1994 Quality systems. Model for quality assurance in production, installation and servicing EN 46001:1993BS EN 46001:1994
13、 Application of EN 29001 (BS 5750-1) to the manufacture of medical devices EN 46002:1993BS EN 46002:1994 Application of EN 29002 (BS 5750-2) to the manufacture of medical devices a Superseded by ISO 9001:1994. b Superseded by ISO 9002:1994. Summary of pages This document comprises a front cover, an
14、inside front cover, pages i and ii, the EN title page, pages 2 to 18, an inside back cover and a back cover. This standard has been updated (see copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover. Licensed Copy: sheffield
15、un sheffieldun, na, Mon Nov 06 02:03:04 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 50103 June 1995 ICS 03.120.10; 11.040.00 Descriptors: Medical electrical equipment, active medical device, quality system, quality assurance, manufacturing English
16、version Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for the active (including active implantable) medical device industry Guide pour lapplication des EN 29001 et EN 46001 et des EN 29002 et EN 46002 lindustrie des dispositifs mdicaux actifs (comprenant les dispo
17、sitifs actifs implantables) Anleitung fr die Anwendung von EN 29001 und EN 46001 und von EN 29002 und EN 46002 fr die aktive (einschlielich implantierbare aktive) Medizinprodukte herstellende Industrie This European Standard was approved by CENELEC on 1994-07-05. CENELEC members are bound to comply
18、with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secret
19、ariat or to any CENELEC member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CENELEC member into its own language and notified to the Central Secretariat has the same status as th
20、e official versions. CENELEC members are the national electrotechnical committees of Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. CENELEC European Committee for Electrot
21、echnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: rue de Stassart 35, B-1050 Brussels 1995 Copyright reserved to CENELEC members Ref. No. EN 50103:1995 E Licensed Copy: sheffieldun sheffieldun, na, Mon Nov 0
22、6 02:03:04 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 50103:1995 BSI 01-2000 2 Foreword This European Standard was prepared by the Working Groups “Quality systems for active implantable medical devices” and “GMP for active medical devices” of Technical Committee CENELEC TC 62, Electrical equipmen
23、t in medical practice, with advice from the joint CEN/CENELEC “Coordinating Working Group on Quality Supplements”. The draft was submitted to the IEC-CENELEC parallel vote as prEN 61272 in October 1993. Although approved at IEC level, the IEC was not in a position to issue the document as an Interna
24、tional Standard because the documents EN 46001 and EN 46002 referred to have not been approved on an international basis. The draft was approved by CENELEC as EN 50103 on 1994-07-05. The following dates were fixed: Contents Page Foreword2 Introduction3 1Scope3 2Normative references3 3Terminology and
25、 definitions4 3.1Terminology4 3.2Definitions4 4Guidance on QUALITY SYSTEM requirements4 4.1Management responsibility4 4.2QUALITY SYSTEM6 4.3Contract review6 4.4Design control6 4.5Document control8 4.6Purchasing8 4.7PURCHASER supplied PRODUCT10 4.8PRODUCT identification and traceability10 4.9Process
26、control10 4.10 INSPECTION and testing11 4.11 INSPECTION, measuring and test equipment12 4.12 INSPECTION and test status12 4.13 Control of non-conforming PRODUCT12 4.14 CORRECTIVE ACTION12 4.15 Handling, storage, packaging and delivery13 4.16 Quality records14 4.17 Internal QUALITY AUDITS15 4.18 Trai
27、ning15 4.19 Servicing15 4.20 Statistical techniques16 Annex A (informative) Terminology Index of terms17 Annex B (informative) Bibliography18 latest date by which the EN has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 1995-12-15 latest
28、 date by which the national standards conflicting with the EN have to be withdrawn(dow) 1995-12-15 Licensed Copy: sheffieldun sheffieldun, na, Mon Nov 06 02:03:04 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 50103:1995 BSI 01-20003 Introduction This European Standard gives guidelines for SUPPLIERS
29、OF ACTIVE MEDICAL DEVICES (including ACTIVE IMPLANTABLE MEDICAL DEVICES) who wish to ensure that they comply with EN 46001 (Quality systems Medical devices Particular requirements for the application of EN 29001 for medical devices) or EN 46002 (Quality systems Medical devices Particular requirement
30、s for the application of EN 29002 for medical devices). Additionally this European Standard is intended to contribute to a common understanding between SUPPLIERS and third parties. This European Standard is meaningful only if read in conjunction with EN 29000/ISO 9000 and EN 46000 series of standard
31、s. The guidelines are not intended as a replacement or supplement to ISO 9004, which has its own very distinct relationship with the EN 29000/ISO 9000 series of standards. NOTE 1The guidance given in this document has been arranged so that the numbers of the subclauses are the same as those of the r
32、equirements of EN 29001 and EN 46001, to which the guidance always refers. The respective subclause numbers of EN 29002 and EN 46002 are provided in parentheses. NOTE 2Not all requirements of EN 29001 and EN 46001 and of EN 29002 and EN 46002 are addressed in this European Standard. It is, therefore
33、, generally advisable to read these guidelines in parallel with ISO 9004. NOTE 3This document provides guidelines both for manufacturers of ACTIVE MEDICAL DEVICES and ACTIVE IMPLANTABLE MEDICAL DEVICES. Most of the wording of this document is drafted to cover both PRODUCT groups: the class ACTIVE ME
34、DICAL DEVICE includes ACTIVE IMPLANTABLE MEDICAL DEVICES by definition. In a few places the guidance applies specifically only to ACTIVE IMPLANTABLE MEDICAL DEVICES or to non-implantable ACTIVE MEDICAL DEVICES: such exceptions are clearly indicated in the text. 1 Scope The guidelines contained in th
35、is European Standard are applicable to a QUALITY SYSTEM as specified by EN 29001 and EN 46001 or EN 29002 and EN 46002. This European Standard does not add to, or otherwise change the requirements of those standards, and is not intended to be used directly in the assessment of a SUPPLIERS QUALITY SY
36、STEM. The guidelines provide concepts and objectives which should be considered by a SUPPLIER of ACTIVE MEDICAL DEVICES while developing and maintaining his QUALITY SYSTEM. This European Standard: provides examples of how to meet the requirements, while recognizing that other methods which achieve t
37、he same ends are equally acceptable; gives general advice on how to meet the requirements; draws attention to aspects of requirements that may not be readily apparent to those unfamiliar with QUALITY SYSTEMS used in the ACTIVE MEDICAL DEVICE industry. 2 Normative references This European Standard in
38、corporates by dated or undated reference provisions from other publications. These normative references are cited at the appropriate places in the text and the publications are listed hereafter. For dated references, subsequent amendments to or revisions of any of these publications apply to this Eu
39、ropean Standard only when incorporated in it by amendment or revision. For undated references, the latest edition of the publication referred to applies. International registration: Title:European registration: ISO 8402: 1994 Quality management and quality assurance Vocabulary ISO 9001: 1987 Quality
40、 systems Model for quality assurance in design/development, production, installation and servicing EN 29001:1987 ISO 9002: 1988 Quality systems Model for quality assurance in production and installation EN 29002:1988 Quality systems Medical devices Particular requirements for the application of EN 2
41、9001 EN 46001:1993 Quality systems Medical devices Particular requirements for the application of EN 29002 EN 46002:1993 Licensed Copy: sheffieldun sheffieldun, na, Mon Nov 06 02:03:04 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 50103:1995 4 BSI 01-2000 3 Terminology and definitions 3.1 Terminolog
42、y 3.1.1 should this auxiliary verb indicates that a certain course of action is preferred but not necessarily required 3.1.2 may this auxiliary verb indicates a course of action often followed by established SUPPLIERS of similar ACTIVE MEDICAL DEVICES 3.1.3 specific this adjective, when used with pa
43、rameters or conditions, refers to a particular value or standardized arrangement, usually to those required in a European Standard or a legal requirement 3.1.4 specified this adjective, when used with parameters or conditions, refers to a value or arrangement to be chosen for the purpose under consi
44、deration and indicated usually in accompanying documents 3.2 Definitions NOTEIn this European Standard, terms printed in capital letters are used as defined in EN 46001 and ISO 8402 or as given in subclauses 3.2.1 to 3.2.4. Annex A provides an index of the terms used. Where a defined term is used as
45、 a qualifier in another term it is not printed in capital letters, unless the concept thus qualified is also defined. For the purposes of this European Standard, the definitions given in ISO 8402 and EN 46001 apply together with the following definitions. 3.2.1 specified requirements either: require
46、ments prescribed by the PURCHASER and agreed by the SUPPLIER in a contract for PRODUCT; requirements prescribed by the SUPPLIER which are perceived as satisfying a market need; regulatory requirements 3.2.2 device history record a compilation of records containing the complete production history of
47、a finished device 3.2.3 device master record a compilation of records containing the design, SPECIFICATION, complete manufacturing PROCEDURES, QUALITY ASSURANCE requirements and labels and LABELLING of a finished device 3.2.4 custom-made devices any MEDICAL DEVICE specifically made in accordance wit
48、h a duly qualified medical practitioners written prescription which gives, under his authority, specific design characteristics and is intended to be used only for an individual named patient 4 Guidance on QUALITY SYSTEM requirements 4.1 Management responsibility 4.1.1 Quality policy (Also applies t
49、o 4.1.1 of EN 29002 and EN 46002; see note 1 in Introduction). When defining and documenting the SUPPLIERS QUALITY POLICY, commitment and objectives, the management should express the policy in language that the staff can understand. The policy should be specific to the PRODUCT supplied and to the staff employed. Management should be seen to demonstrate commitment to their QUALITY POLICY both actively and on a continuing basis. 4.1.2 Organization 4.1.2.1 Responsibility and authority (Also applies to 4.1.2.1 of EN 29002