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1、BRITISH STANDARD BS EN ISO 14630:2005 Non-active surgical implants General requirements The European Standard EN ISO 14630:2005 has the status of a British Standard ICS 11.040.40 ? Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:56:42 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 14
2、630:2005 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 2 August 2005 BSI 2 August 2005 ISBN 0 580 46223 4 National foreword This British Standard is the official English language version of EN ISO 14630:2005. It is identical with ISO 14630:
3、2005. It supersedes BS EN ISO 14630:1998 which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee CH/150, Implants for surgery, which has the responsibility to: A list of organizations represented on this committee can be obtained on request to its secretary.
4、Cross-references The British Standards which implement international publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British
5、Standards Online. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to
6、 the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep UK interests informed; monitor related international and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside fro
7、nt cover, the EN ISO title page, the EN ISO foreword page, the ISO title page, pages ii to v, a blank page, pages 1 to 13, the Annex ZA page, an inside back cover and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Amendments issued sinc
8、e publication Amd. No. DateComments Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:56:42 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 14630 May 2005 ICS 11.040.40 Supersedes EN ISO 14630:1997 English version Non-active surgical implan
9、ts - General requirements (ISO 14630:2005) Implants chirurgicaux non actifs - Exigences gnrales (ISO 14630:2005) Nichtaktive chirurgische Implantate - Allgemeine Anforderungen (ISO 14630:2005) This European Standard was approved by CEN on 22 April 2005. CEN members are bound to comply with the CEN/C
10、ENELEC 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 Secretariat or to an
11、y 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 Secretariat has the same status as the official versions. C
12、EN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland
13、and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2005 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN IS
14、O 14630:2005: E Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:56:42 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 14630:2005 Foreword This document (EN ISO 14630:2005) has been prepared by Technical Committee ISO/TC 150 “Implants for surgery“ in collaboration with Technical Committee
15、 CEN/TC 285 “Non-active surgical implants“, the secretariat of which is held by NEN. 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 November 2005, and conflicting national standards shall be with
16、drawn at the latest by November 2005. This document supersedes EN ISO 14630:1997. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For relationship with EU Directiv
17、e(s), see informative Annex ZA, which is an integral part of this document. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Fi
18、nland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Endorsement notice The text of ISO 14630:2005 has been approved by CEN as EN ISO 14630:200
19、5 without any modifications. Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:56:42 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Reference number ISO 14630:2005(E) INTERNATIONAL STANDARD ISO 14630 Second edition 2005-05-01 Non-active surgical implants General requirements Implants chirurgicau
20、x non actifs Exigences gnrales EN ISO 14630:2005 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:56:42 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:56:42 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 14630:2005 iii Contents Pag
21、e Foreword iv Introduction v 1 Scope 1 2 Normative references . 1 3 Terms and definitions. 2 4 Intended performance 3 5 Design attributes. 3 6 Materials. 4 7 Design evaluation . 5 7.1 General . 5 7.2 Pre-clinical evaluation 5 7.3 Clinical evaluation. 5 7.4 Post market surveillance 5 8 Manufacture. 5
22、 9 Sterilization 5 9.1 General . 5 9.2 Products supplied sterile . 6 9.3 Sterilization by the user 6 9.4 Sterilization residuals . 6 10 Packaging 6 10.1 Protection from damage in storage and transport 6 10.2 Maintenance of sterility in transit 7 11 Information supplied by the manufacturer. 7 11.1 Ge
23、neral . 7 11.2 Labelling. 7 11.3 Instructions for use. 8 11.4 Restrictions on combinations 9 11.5 Marking on implants . 9 11.6 Marking for special purposes 10 Annex A (informative) Correspondence of the clauses of this International Standard to the fundamental principles as outlined in ISO/TR 14283:
24、2004 . 11 Bibliography . 12 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:56:42 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iv Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparin
25、g International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liai
26、son with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of t
27、echnical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is d
28、rawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 14630 was prepared by Technical Committee ISO/TC 150, Implants for surgery. This second edition cancels and rep
29、laces the first edition (ISO 14630:1997), which has been technically revised. For the purposes of this International Standard, the CEN annex regarding fulfilment of European Council Directives has been removed. EN ISO 14630:2005 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:56:42 GMT+00:
30、00 2006, Uncontrolled Copy, (c) BSI v Introduction This International Standard provides a method of addressing the fundamental principles outlined in ISO/TR 14283, as they apply to non-active surgical implants. It also provides a method to demonstrate compliance with the relevant essential requireme
31、nts as outlined in general terms in Annex 1 of the European Community Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, as they apply to non- active surgical implants, hereafter referred to as implants. It may also assist manufacturers to comply with the requirements of other r
32、egulatory bodies. There are three levels of standards dealing with non-active surgical implants and related instrumentation. For the implants themselves these are as follows, with Level 1 being the highest: Level 1: General requirements for non-active surgical implants; Level 2: Particular requireme
33、nts for families of non-active surgical implants; Level 3: Specific requirements for types of non-active surgical implants. This standard is a Level 1 standard and contains requirements that apply to all non-active surgical implants. It also anticipates that there are additional requirements in the
34、Level 2 and Level 3 standards. The Level 2 standards apply to a more restricted set or family of non-active surgical implants such as those designed for use in neurosurgery, cardiovascular surgery, or joint replacement. The Level 3 standards apply to specific types of implants within a family of non
35、-active surgical implants such as hip joints or arterial stents. To address all requirements for a specific implant the standard of the lowest available level should be consulted first. References to other International Standards can also be found in the Bibliography. The requirements in this Intern
36、ational Standard correspond to international consensus. Individual or national standards or regulatory bodies may prescribe other requirements. EN ISO 14630:2005 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:56:42 GMT+00:00 2006, Uncontrolled Copy, (c) BSI blank Licensed Copy: sheffieldu
37、n sheffieldun, na, Fri Nov 17 09:56:42 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 1 Non-active surgical implants General requirements 1 Scope This International Standard specifies general requirements for non-active surgical implants, hereafter referred to as implants. It is not applicable to dental
38、 implants, dental restorative materials, transendodontic and transradicular implants and intra-ocular lenses. With regard to safety, this International Standard gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and inf
39、ormation supplied by the manufacturer, and tests required to demonstrate compliance with these requirements. Additional tests are given or referred to in Level 2 and Level 3 standards. 2 Normative references The following referenced documents are indispensable for the application of this document. F
40、or dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 31 (all parts), Quantities and units ISO 8601, Data elements and interchange formats Information interchange Representation of dates and
41、times ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing ISO 10993-7, Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals ISO 11135:1), Sterilization of health care products Ethylene oxide Requirements for development, validation
42、and routine control of a sterilization process for medical devices ISO 11137, Sterilization of health care products Requirements for validation and routine control Radiation sterilization2) ISO 11607, Packaging for terminally sterilized medical devices ISO 13408-1, Aseptic processing of health care
43、products Part 1: General requirements ISO 14155-1, Clinical investigation of medical devices for human subjects Part 1: General requirements ISO 14160, Sterilization of single-use medical devices incorporating materials of animal origin Validation and routine control of sterilization by liquid chemi
44、cal sterilants 1) To be published. (Revision of ISO 11135:1994). ISO 11135:1994 is not identical to EN 550, which was referenced in the last edition of ISO 14630. However, a revision of ISO 11135:1994 is under development and will be harmonized under the EU Medical Device Directive. 2) ISO 11137:199
45、5 is not identical to EN 552 wich was referenced in the last edition of ISO 14630, however, a revision of this standard is under development and will be harmonized. EN ISO 14630:2005 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:56:42 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 2 ISO 1493
46、7, Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices ISO 14971, Medical devices Application of risk management to medical devices ISO 17664, Sterili
47、zation of medical devices Information to be provided by the manufacturer for the processing of resterilizable medical devices ISO 17665:3), Sterilization of health care products Moist heat Development, validation and routine control of a sterilization process for medical devices EN 12442-1, Animal t
48、issues and their derivatives utilized in the manufacture of medical devices Part 1: Analysis and management of risk EN 12442-2, Animal tissues and their derivatives utilized in the manufacture of medical devices Part 2: Controls on sourcing, collection and handling EN 12442-3, Animal tissues and the
49、ir 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 document, the following terms and definitions apply. 3.1 surgical implant device which is intended to be totally introduced into the human body, or to replace an epithelial surface or the surface of the eye, by surgical intervention which is inten