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1、BRITISH STANDARD BS EN ISO 14630:1998 General requirements for non-active surgical implants This European Standard EN ISO 14630:1997 has the status of a British Standard ICS 11.040.40 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:52:11 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO
2、 14630:1998 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 January 1998 BSI 03-1999 ISBN 0 580 28055 1 National foreword This British Standard is the Engl
3、ish language version of EN ISO 14630:1997. It is identical with ISO 14630:1997. The UK participation in its preparation was entrusted to Technical Committee CH/49, Surgical implants (International), which has the responsibility to: aid enquirers to understand the text; present to the responsible int
4、ernational/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. A list of organizations represented on this committee can be obtained on request. Cro
5、ss-references Attention is drawn to the fact that CEN and CENELEC standards normally include an annex which lists normative references to international publications with their corresponding European publications. The British Standards which implement international or European publications referred t
6、o in this document may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or 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.
7、 Users of British Standards are responsible 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 ISO title page, pages 2 to 9
8、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. Amendments issued since publication Amd. No.DateComments Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:
9、52:11 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 14630:1998 BSI 03-1999i Contents Page National forewordInside front cover Foreword 2 Text of EN ISO 14630 3 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:52:11 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii blank Licensed Copy: sh
10、effieldun sheffieldun, na, Wed Nov 15 12:52:11 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 14630 November 1997 ICS 11.040.40 Descriptors: Medical equipment, surgical implants, specifications, performance, sterilization, marking, packaging, gene
11、ralities English version Non-active surgical implants General requirements (ISO 14630:1997) Implants chirurgicaux non actifs Exigences gnrales (ISO 14630:1997) Nichtaktive chirurgische Implantate Allgemeine Anforderungen (ISO 14630:1997) This European Standard was approved by CEN on 4 July 1997. CEN
12、 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 on appl
13、ication 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 Secretariat has
14、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, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. CEN European Comm
15、ittee for Standardization Comit Europen de Normalisation Europisches Komitee fr Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1997 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 14630:1997 E Licensed Copy: s
16、heffieldun sheffieldun, na, Wed Nov 15 12:52:11 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 14630:1997 BSI 03-1999 2 Foreword The text of EN ISO 14630:1997 has been prepared by Technical Committee CEN/TC 285 “Non-active surgical implants”, the secretariat of which is held by NNI, in collaborat
17、ion with Technical Committee ISO/TC 150 “Implants for surgery”. 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 May 1998, and conflicting national standards shall be withdrawn at the latest by May
18、 1998. This European Standard 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). There are three levels of European Standards dealing with non-active surgical implants. These are a
19、s follows, with level 1 being the highest: level 1: General requirements for non-active surgical implants; level 2: Particular requirements 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
20、contains requirements that apply to all non-active surgical implants. It also indicates that there are additional requirements in the level 2 and level 3 standards. The level 2 standards apply to a more restricted set or family of implants such as those designed for use in osteosynthesis, cardiovasc
21、ular surgery, or joint replacement. The level 3 standards apply to specific types of implants within a family such as hip joints or mammary implants. All European Standards currently available or in preparation are listed in the bibliography (see Annex A ). To address all requirements, it is necessa
22、ry to start with a standard of the lowest available level. References to other European or International Standards can also be found in Annex A “Bibliography”. For relationship with EU Directive(s), see informative Annex ZB, which is an integral part of this standard. NOTEThe European Standards list
23、ed in the bibliography have not been adopted as International Standards in all cases (see also notes in Introduction and clause 2). According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austri
24、a, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Contents Page Foreword 2 Introduction3 1Scope3 2Normative references3 3Definitions3 4Intended performance4 5De
25、sign attributes4 6Materials5 7Design evaluation5 8Manufacture5 9Sterilization5 10Packaging6 11Information supplied by the manufacturer6 Annex A (informative) Bibliography7 Annex B (informative) Clauses of this European Standard addressing requirements or other provisions of EU Directives8 Table B.19
26、 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:52:11 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 14630:1997 BSI 03-19993 Introduction This European Standard provides a method to demonstrate compliance with the relevant essential requirements as outlined in general terms in Annex 1
27、of the 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 also provides a method of addressing the fundamental principles outlined in ISO/TR 14283, as they apply to non active surgical implants.
28、 For such products, particular and specific requirements may apply. These additional requirements are specified in the level 2 and 3 standards or their parts. NOTEThe structure of this standard and the normative references of this standard are based on the use of the standard in supporting Council D
29、irective 93/42/EEC. For the European Standards listed in the normative references (see clause 2), in some cases International Standards are available (see also clause 2, NOTE 1). Users of International Standards should be aware that they may not necessarily meet the essential requirements of the Cou
30、ncil Directive 93/42/EEC or other regulatory requirements for other countries or regions. 1 Scope This European Standard specifies general requirements for non-active surgical implants. This standard is not applicable to dental implants, dental restorative materials, transendodontic and transradicul
31、ar implants and intraocular lenses. With regard to safety, this standard gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests. Tests required to be used to demonstra
32、te compliance with this standard are contained in other levels. 2 Normative references This European Standard incorporates 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 her
33、eafter. 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 revision. For undated references the latest edition of the publication referred to applies. EN 540, Clinical investigations of
34、 medical devices for human subjects. EN 550, Sterilization of medical devices Validation and routine control of ethylene oxide sterilization. EN 552, Sterilization of medical devices Validation and routine control of sterilization by irradiation. EN 554, Sterilization of medical devices Validation a
35、nd routine control of steam sterilization by moist heat. EN 556, Sterilization of medical devices Requirements for medical devices labelled “Sterile”. EN 868-1, Packaging materials for sterilization of wrapped goods Part 1: General requirements and requirements for the validation of packaging for te
36、rminally sterilized devices. EN 980, Terminology, symbols and information provided with medical devices Graphical symbols for use in the labelling of medical devices. prEN 1041, Terminology, symbols and information provided with medical devices Information supplied by the manufacturer with medical d
37、evices. prEN 1441, Medical devices Risk analysis. prEN ISO 10993-1, Biological evaluation of medical and dental materials and devices Part 1: Guidance on selection of tests. NOTE 1For some of the European Standards listed in this clause, an identical or technically related International Standards is
38、 available. These International Standards are listed in A.3. NOTE 2Annex A “Bibliography” summarizes informative references to other parts of this standard and other European Standards, as well as informative references which are cited in the text. 3 Definitions For the purposes of this European Sta
39、ndard the following definitions apply: 3.1 non-active surgical implant implantable device which is not an active medical device 3.2 implantable device device which is intended: to be totally introduced into the human body or, to replace an epithelial surface or the surface of the eye, Licensed Copy:
40、 sheffieldun sheffieldun, na, Wed Nov 15 12:52:11 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 14630:1997 4 BSI 03-1999 by surgical intervention which is intended to remain in place after the procedure. Any medical device intended to be partially introduced into the human body through surgical
41、intervention and intended to remain in place after the procedure for at least 30 days is also considered an implantable device 3.3 active medical device medical device operation of which depends on a source of electrical energy or any source of power other than that directly generated by the human b
42、ody or gravity and which acts by converting this energy. Medical devices intended to transmit energy, substances or other elements between an active medical device and the patient, without any significant change are not considered to be active medical devices 3.4 safety freedom from unacceptable ris
43、k of harm 3.5 implantable state condition of an implant prepared for implantation into a human subject 3.6 leakage unintended movement of fluid including body fluids into or out of implants through a defect in the structure of the containing wall 3.7 coating layer of material used to cover or partia
44、lly cover a surface of an implant 4 Intended performance The intended performance of an implant shall be described and documented by addressing the following: functional characteristics; typical intended applications; intended conditions of use; with particular regard to safety. NOTEAccount should b
45、e taken of: published standards; published clinical and scientific literature; validated test results. 5 Design attributes The design attributes to meet the intended performance shall take into account at least the following: a) materials and their biocompatibility (see clause 6); b) physical, mecha
46、nical and chemical properties of materials, including endurance properties and ageing (see clauses 6 and 7); c) wear characteristics of materials and the effects of wear and wear products on the implant and the body (see clauses 6 and 7); d) effect of manufacturing processes (including sterilization
47、) on material characteristics and performance (see clauses 6, 7, 8 and 9); e) possible effects on the implant and its function due to interactions between its constituent materials and other materials and substances (see clauses 6 and 7); f) extent and effect of leakage and/or diffusion of substance
48、s used to fill implants (see clauses 6 and 7); g) interconnections and their effects on the intended performance (see clause 7); h) interface(s) between the implant and body tissue(s), particularly relative to fixation and connection, and surface conditions (see clause 7); i) shape and dimensions in
49、cluding their possible effects on tissues and body fluids (see clause 7); j) biocompatibility of the implant in its implantable state (see clauses 6 and 7); k) physical and chemical effects of the body and external environment on the implant (see clause 7); l) effects of radiation and electromagnetic fields on the implant and consequential effects on the body (see clauses 6.1 and 7); m) ability to implant, to remove and to replace the implant after implantation (see clause 7); n) microbiological and particulate contaminat
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