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1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 12442-1:2000 The Eu
2、ropean Standard EN 12442-1:2000 has the status of a British Standard ICS 11.120.01 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Animal tissues and their derivatives utilized in the manufacture of medical devices Part 1: Analysis and management of risk Licensed Copy: sheffie
3、ldun sheffieldun, na, Sat Oct 28 05:28:34 GMT+00:00 2006, Uncontrolled Copy, (c) BSI This British Standard, having been prepared under the direction of the Health and Environment Sector Committee, was published under the authority of the Standards Committee and comes into effect on 15 November 2000
4、BSI 11-2000 ISBN 0 580 34966 7 BS EN 12442-1:2000 Amendments issued since publication Amd. No.DateComments National foreword This British Standard is the official English language version of EN 12442-1:2000. The UK participation in its preparation was entrusted to Technical Committee CH/7, Medical d
5、evices utilizing tissues, which has the responsibility to: aid enquirers to understand the text; present to the responsible European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and
6、 promulgate them in the UK. A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Standards Catalogue under
7、the section entitled International Standards Correspondence Index, or by using the Find facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct applicat
8、ion. 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, the EN title page, pages 2 to 20, an inside back cover and a back cover. The BSI copyright notice displayed in this docume
9、nt indicates when the document was last issued. Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:28:34 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 12442-1 September 2000 ICS 11.120.01 English version Animal tissues and their derivatives ut
10、ilized in the manufacture of medical devices - Part 1: Analysis and management of risk Tissus animaux et leurs drivs utiliss dans la fabrication des dispositifs mdicaux - Partie 1: Analyse et gestion des risques Tierische Gewebe und deren Derivate, die zur Herstellung von Medizinprodukten eingesetzt
11、 werden - Teil 1: Analyse und Handhabung von Risiken This European Standard was approved by CEN on 20 April 2000. 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 a
12、lteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by tran
13、slation under the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, I
14、taly, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2000 CENAll rights of exploitation in any form a
15、nd by any means reserved worldwide for CEN national Members. Ref. No. EN 12442-1:2000 E Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:28:34 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 2 EN 12442-1:2000 ContentsPage Foreword3 Introduction3 1 Scope4 2 Normative references5 3 Terms and
16、definitions5 4 Procedure6 5Requirements for risk management10 6Review of risk analysis11 ANNEX A (informative) Graphical representation of the risk management process12 ANNEX B (informative) Guidance on the application of this Part of EN 1244213 ANNEX C (informative) Applicability of relevant inform
17、ative annexes in EN 144114 Annex D (informative) Transmissible agents risk analysis and management15 Annex ZA (informative) Clauses of this standard addressing Essential Requirements or other provisions of EU Directives19 Bibliography20 Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:28:34
18、 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 3 EN 12442-1:2000 Foreword This European Standard has been prepared by Technical Committee CEN/TC 316 “Medical devices utilizing tissues“, the secretariat of which is held by IBN. This European Standard shall be given the status of a national standard
19、, either by publication of an identical text or by endorsement, at the latest by March 2000, and conflicting national standards shall be withdrawn at the latest by March 2000. This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade
20、 Association, and supports essential requirements of EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this standard. This part of EN 12442 has been considered by CEN/TC 316 as one of a series of European Standards concerned with the devel
21、opment of European Standards for medical devices manufactured utilizing tissues or derivatives of animal origin, non-viable or rendered non- viable. These standards are: EN 12442-2Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 2: Controls on sourcing, coll
22、ection and handling EN 12442-3Animal tissues and their derivatives utilized in the manufacture of medical devices - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible agents According to the CEN/CENELEC Internal Regulations, the national standards organizations of
23、 the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Introduction Certain medical dev
24、ices may contain materials of animal origin. The use of animal tissues and derivatives will give performance characteristics expected to be superior to non-animal based materials such as metal, plastics or textiles. The range and quantities of materials of animal origin in medical devices vary. Thes
25、e materials may comprise a major part of the device (e.g. bovine/porcine heart valves, catgut sutures, haemostatic devices), a product coating or impregnation (e.g. heparin, gelatin, collagen), or an aid to the manufacturing stages of production (e.g. tallow). EN 1441 is a general standard which spe
26、cifies a procedure for the manufacturer to investigate, using available information, the safety of a medical device, including in vitro diagnostic devices or accessories, by identifying hazards and estimating the risk associated with the device. EN 12442-1 provides additional requirements and guidan
27、ce for the evaluation of medical devices manufactured utilizing animal tissues or derivatives which are non-viable or rendered non-viable. This Part of EN 12442 can only be used in combination with EN 1441 and is not a “stand- alone” standard. Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 0
28、5:28:34 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 4 EN 12442-1:2000 NOTE: To show compliance with this standard, its specified requirements should be fulfilled. The guidance given in the NOTES and informative Annexes is not obligatory and is not provided as a checklist for auditors. 1 Scope 1.
29、1This Part of EN 12442 applies to medical devices (excluding in-vitro diagnostic medical devices) manufactured utilizing animal tissue or products derived from animal tissue, which are non-viable or have been rendered non-viable. It specifies, in conjunction with EN 1441, a procedure to investigate,
30、 using available information, the safety of such devices by identifying hazards and estimating the risks associated with the device (risk analysis). 1.2This Part of EN 12442 is intended to provide requirements and guidance on risk analysis related to the typical hazards of medical devices manufactur
31、ed utilizing animal tissues or derivatives such as a) contamination by bacteria, moulds or yeasts; b) contamination by viruses or transmissible agents such as pathogenic entities, or agents causing spongiform encephalopathies, prions and similar entities (e.g. BSE, scrapie); c) undesired pyrogenic,
32、immunological or toxicological reactions. 1.3This Part of EN 12442 does not stipulate levels of acceptability which, because they are determined by a multiplicity of factors, cannot be set down in such a standard. 1.4In addition, this Part of EN 12442 is intended to provide requirements and guidance
33、 on risk management. 1.5This Part of EN 12442 does not cover the utilization of human tissues in medical devices. NOTE: There are materials which do not fall under the scope of this standard because these are not derived from animals. In this standard a specific definition of animal has been given.
34、1.6This Part of EN 12442 does not describe a quality assurance system for the control of all stages of manufacture. NOTE: Attention is drawn to the standards for quality systems (see EN ISO 9001 and EN 46001 or EN ISO 9002 and EN 46002) which relate to all stages of manufacture. It is not a requirem
35、ent of this standard to have a complete quality system during manufacture but certain elements of such a system are required. 1.7The principles of this Part of EN 12442 may also be applied by analogy to medical devices manufactured utilizing material derived from a non-vertebrate organism, in cases
36、where the risks addressed in this standard are relevant. Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:28:34 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 5 EN 12442-1:2000 2 Normative references This European standard incorporates, by dated or undated reference, provisions from other
37、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 amendment or re
38、vision. For undated references, the latest edition of the publication referred to applies (including amendments). EN 1441:1997 Medical Devices - Risk Analysis EN 12442-2:2000 Animal tissues and their derivatives utilized in the manufacture of medical devices Part 2: Control on sourcing, collection a
39、nd handling. EN 12442-3:2000 Animal tissues and their derivatives utilized in the manufacture of medical devices Part 3: Validation of the elimination and/or inactivation of viruses and transmissible agents. 3 Terms and definitions For the purposes of this Part of EN 12442 the following terms and de
40、finitions apply in addition to the terms and definitions contained in EN 1441. 3.1 animal all vertebrates including fish, amphibians, reptiles, birds and mammals, excluding humans (Homo sapiens) EN 12442-2 and EN 12442-3. 3.2 cell smallest organized unit of any living form which is capable of indepe
41、ndent existence and of replacement of its own substance in a suitable environment. 3.3 derivative material obtained from an animal tissue by a manufacturing process EN 12442-2. NOTE 1: Examples of derivatives are: hyaluronic acid, collagen, gelatin, monoclonal antibodies. NOTE 2: Natural substances
42、such as milk, hair, and wool are excluded by this definition. 3.4 elimination/removal process by which the number of viruses and transmissible agents is reduced EN 12442-3. NOTE 1: The effectiveness of the process should be expressed mathematically in terms of a reduction factor (See Annex D of EN 1
43、2442-3:2000). NOTE 2: Elimination/removal aims to prevent infection or pathogenic reaction caused by viruses and/or transmissible agents. Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:28:34 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 6 EN 12442-1:2000 3.5 inactivation process by whic
44、h the ability to cause infection or pathogenic reaction by a virus and/or transmissible agent is reduced EN 12442-2 and EN 12442-3. NOTE 1: The effectiveness of the process should be expressed mathematically in terms of a reduction factor (See Annex D of EN 12442-3:2000). NOTE 2: Inactivation aims t
45、o prevent infection by and replication of viruses or transmissible agents. 3.6 medical device any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for
46、 human beings for the purpose of: - diagnosis, prevention, monitoring, treatment or alleviation of disease, - diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, - investigation, replacement or modification of the anatomy or of a physiological process, - contr
47、ol of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means. NOTE: This definition is identical with that given in Council Directive 93/42/EEC. 3.7 non
48、-viable having no potential for metabolism or multiplication. 3.8 tissue organization of cells and/or extra-cellular constituents EN 12442-2 and EN 12442-3. 3.9 transmissible agents unclassified pathogenic entities, prions and similar entities EN 12442-3. NOTE: e.g. BSE agent, scrapie agent. 4 Proce
49、dure The risk analysis procedure is described in 4.1 to 4.9. The same headings as in EN 1441 have been used. 4.1General (step 1 of Figure 1 of EN 1441:1997) 3.1 of EN 1441:1997 is applicable. The manufacturer shall justify the use of animal material (including animal species and tissues) taking into account the expected clinical benefit and residual risk. Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:28:34 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 7 EN 12442-1:2000 4.2Identification of qualitative and quantitative characteristics rel