《BS-EN-724-1995.pdf》由会员分享,可在线阅读,更多相关《BS-EN-724-1995.pdf(26页珍藏版)》请在三一文库上搜索。
1、BRITISH STANDARD BS EN 724:1995 Guidance on the Application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for non-active medical devices The European Standard EN 724:1994 has the status of a British Standard Licensed Copy: sheffieldun sheffieldun, na, Tue Nov 07 02:55:16 GMT+00:00 2006, Unco
2、ntrolled Copy, (c) BSI BS EN 724:1995 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 April 1995 BSI 11-1998 The following BSI references relate to the wor
3、k on this standard: Committee reference HCC/66 Draft for comment 92/52898 DC ISBN 0 580 23762 1 Committees responsible for this British Standard The preparation of this British Standard was entrusted to Technical Committee HCC/66, Quality systems for the manufacture of medical devices, upon which th
4、e 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.) British Anaesthetic and Respiratory Equipment Manufacturers Association B
5、ritish In Vitro Diagnostics Association British Orthopaedic Association British Surgical Trades Association Dental Laboratories Association Limited Department of Health Electro Medical Trade Association Limited GAMBICA (BEAMA Ltd.) Guild of Hospital Pharmacists Institute of Physical Sciences in Medi
6、cine (ISPM) Institute of Quality Assurance Medical Sterile Products Association Surgical Dressings Manufacturers Association Amendments issued since publication Amd. No.DateComments Licensed Copy: sheffieldun sheffieldun, na, Tue Nov 07 02:55:16 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 724:1
7、995 BSI 11-1998i Contents Page Committees responsibleInside front cover National forewordii Foreword2 Text of EN 7243 Licensed Copy: sheffieldun sheffieldun, na, Tue Nov 07 02:55:16 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 724:1995 ii BSI 11-1998 National foreword This British Standard has b
8、een prepared by Technical Committee HCC/66 and is the English language version of EN 724:1994 Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for non-active medical devices, published by the European Committee for Standardization (CEN). BS EN 724 provides guidance o
9、n the operation of quality management systems used in the manufacture of non-active medical devices. A similar standard, BS EN 501031), covers guidance for the manufacture of active medical devices including active implantable medical devices. In addition another standard, BS EN 928, which will prov
10、ide guidance on quality management systems used in the manufacture of in vitro diagnostic devices, is in preparation. Cross-references Publication referred to Corresponding British Standard BS 5750 Quality systems EN 29001:19872)Part 1:1987 Specification for design/development, production, installat
11、ion and servicing EN 29002:19872)Part 2:1987 Specification for production and installation EN 29004:19872)Part 0: Principal concepts and applications Section 0.2:1987 Guide to quality management and quality system elements EN 46001:1993BS EN 46001:1994 Specification for application of EN 29001 (BS 5
12、750-1) to the manufacture of medical devices EN 46002:1993BS EN 46002:1994 Specification for application of EN 29002 (BS 5750-2) to the manufacture of medical devices A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible
13、 for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, the EN title page, pages 2 to 21 and a back cover. This standard has been updat
14、ed (see copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover. 1) In preparation. 2) For information, since the ratification of this European Standard, EN 29001:1987, EN 29002:1987 and EN 29004:1987 have been superseded by E
15、N ISO 9001:1994, EN ISO 9002:1994 and EN ISO 9004-1:1994. The corresponding British Standards are BS EN ISO 9001:1994, BS EN ISO 9002:1994 and BS EN ISO 9004-1:1994. Licensed Copy: sheffieldun sheffieldun, na, Tue Nov 07 02:55:16 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUR
16、OPENNE EUROPISCHE NORM EN 724 October 1994 ICS 11.020; 11.040.30 Descriptors: Medical equipment, design, manufacturing, quality, quality assurance, quality control, specifications, maintenance English version Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for non-a
17、ctive medical devices Guide dapplication des EN 29001 et EN 46001 et des EN 29002 et EN 46002 pour les dispositifs mdicaux non actifs Anleitung zur Anwendung von EN 29001 und EN 46001 und von EN 29002 und EN 46002 fr nicht-aktive Medizinprodukte This European Standard was approved by CEN on 1994-10-
18、27. CEN members are bound to comply 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
19、on application to the Central Secretariat or to any CEN 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 CEN member into its own language and notified to the Central Secretari
20、at has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. CEN European Committee for
21、 Standardization Comit Europen de Normalisation Europisches Komitee fr Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1994 Copyright reserved to CEN members Ref. No. EN 724:1994 E Licensed Copy: sheffieldun sheffieldun, na, Tue Nov 07 02:55:16 GMT+00:00 2006, Uncontrolled Copy, (c)
22、 BSI EN 724:1994 2 BSI 11-1998 Foreword This European Standard was prepared by the Technical Committee CEN TC 205, Non-active medical devices, the Secretariat of which is held by BSI. This European Standard has been prepared under a Mandate given to CEN by the European Commission and the Secretariat
23、 of the European Free Trade Association, and supports essential requirements of EC Directive(s). This European Standard shall be given the status of a National Standard, either by publication of an identical text or by endorsement, at the latest by April 1995, and conflicting national standards shal
24、l be withdrawn at the latest by April 1995. Annexes designated informative are given only for information. In this standard annexes A, B and C are informative. According to the CEN/CENELEC Internal Regulations, the following countries are bound to implement this European Standard: Austria, Belgium,
25、Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom. Contents Page Foreword 2 Introduction 3 1Scope3 2Normative references3 3Definitions3 4Guidance on quality system requirements4 4.1Management resp
26、onsibility4 4.2Quality system5 4.3Contract review5 4.4Design control5 4.5Document control7 4.6Purchasing8 4.7Purchaser supplied product8 4.8Product identification and traceability9 4.9Process control9 4.10Inspection and testing11 4.11Inspection, measuring and test equipment12 4.12Inspection and test
27、 status12 4.13Control of nonconforming product12 4.14Corrective action12 4.15Handling, storage, packaging and delivery13 4.16Quality records15 4.17Internal quality audits15 4.18Training16 4.19Servicing16 4.20Statistical techniques16 Annex A (informative) Guidance on elements of quality systems relev
28、ant to sterile product manufacture17 Annex B (informative) Features of job descriptions of key individuals20 Annex C (informative) Bibliography21 Licensed Copy: sheffieldun sheffieldun, na, Tue Nov 07 02:55:16 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 724:1994 BSI 11-19983 Introduction This Euro
29、pean Standard has been written to give guidance to organizations providing a non-active medical device who wish to ensure that they will comply with EN 29001/EN 29002 and the particular requirements given in EN 46001/EN 46002. It is also intended to provide guidance for certifying and regulatory bod
30、ies. The guidance in this standard for the fulfilment of requirements should always be in relation to the products being manufactured and interpreted accordingly. This standard needs to be read in conjunction with the EN 29000 series of standards with which compliance is sought. This standard is not
31、 intended as a replacement for EN 29004 which has its own very distinct relationship with the EN 29000 series of standards. The combination of EN 29001/EN 46001 and EN 29002/EN 46002 embraces the principles of Good Manufacturing Practices (GMP) which have been in operation in the manufacture of non-
32、active medical devices for a number of years. This document seeks to assist in the transition from GMP to quality systems by presenting familiar concepts under the relevant paragraphs of EN 29001/EN 46001 and EN 29002/EN 46002. The references which have been made to EN 29004 are not necessarily exha
33、ustive but seek to identify sections of EN 29004 with particular relevance to the guidance in this document. Consideration of this document alone is not an alternative to understanding EN 29004 and it is therefore recommended that EN 29004 is first read and understood in its entirety. For ease in th
34、e use of this standard, references to clauses in EN 29004 have been cited within the framework of EN 29001 and EN 29002. Annex A to this European Standard provides additional guidance on those elements of quality systems to which particular emphasis should be placed for medical devices which are sup
35、plied either sterile or to a defined standard of microbial or particulate cleanliness. The guidance in annex A is intended to be considered in addition to that provided in the body of the standard. 1 Scope This European Standard provides guidance on the establishment and maintenance of the quality s
36、ystems specified in EN 29001/EN 46001 or EN 29002/EN 46002 for the manufacture of non-active medical devices. It does not add to, or otherwise change, the requirements of those standards and is not intended to be used for the assessment of a manufacturers quality system. This European Standard provi
37、des examples of how to meet the requirements, recognizing that other methods which achieve the same ends are equally acceptable; gives general advice on how to meet the requirements; and draws attention to aspects of requirements that may not be readily apparent to those unfamiliar with quality syst
38、ems for non-active medical devices. Annex A to this European Standard provides guidance on the elements of quality systems which are relevant to the manufacture of medical devices which are to be supplied either sterile or at a defined level of microbiological or particulate cleanliness. The adoptio
39、n of systems other than those described in this European Standard is not to be regarded as a non-compliance with EN 29001 and EN 29002 and/or the specific requirements in EN 46001 and EN 46002. 2 Normative references This European Standard incorporates, by dated or undated reference, provisions from
40、 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 European Standard only when incorporated in it by amendmen
41、t or revision. For undated references the latest edition of the publication referred to applies. EN 29001:1987, Quality systems Model for quality assurance in design/development, production, installation and servicing. EN 29002:1987, Quality systems Model for quality assurance in production and inst
42、allation. EN 29004:1987, Quality management and quality system elements Guidelines. EN 46001:1993, Quality systems Medical devices Particular requirements for the application of EN 29001. EN 46002:1993, Quality systems Medical devices Particular requirements for the application of EN 29002. 3 Defini
43、tions For the purpose of this standard the definitions given in EN 46001 and EN 46002 apply, together with the following: 3.1 contract any agreement between the supplier and the purchaser concerning the supply of product NOTEA contract may be in writing, verbal, or a combination of both. Licensed Co
44、py: sheffieldun sheffieldun, na, Tue Nov 07 02:55:16 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 724:1994 4 BSI 11-1998 3.2 design process of developing a product from concept to manufacture 3.3 purchaser recipient of product and/or service delivered by the supplier 3.4 specified requirements any
45、of the following apply: a) requirements prescribed by the purchaser and agreed by the supplier in a contract for product; b) requirements prescribed by the supplier which are perceived as satisfying a market need; or c) regulatory requirements. 3.5 validation exercise of carrying out a programme des
46、igned and documented to demonstrate that a process, operating within specified limits, will consistently produce product or services complying with predetermined requirements NOTEValidation is considered as a total process which consists of: a) obtaining and documenting evidence that the installatio
47、n of equipment follows design intentions and that the equipment as installed will perform consistently within predetermined limits (commissioning); and b) obtaining and documenting evidence that the equipment as installed and operated in accordance with process specifications will function reliably,
48、 produce acceptable product or services, and that key process variables are known (performance qualification). 4 Guidance on quality system requirements 4.1 Management responsibility 4.1.1 Quality policy Guidance for clauses 4.1.1 of EN 29001 and EN 46001 and for clauses 4.1.1 of EN 29002 and EN 460
49、02. 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. For general guidance see 4.1, 4.2, 4.3 and 4.4.4 of EN 29004. 4.1.2 Organization 4.1.2.1 Responsibility and authority Guidance for clauses 4.1.2.1 of EN 29001 and EN 46001 and for clause
链接地址:https://www.31doc.com/p-3747218.html