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1、BRITISH STANDARD BS EN ISO 10993-17:2002 Biological evaluation of medical devices Part 17: Establishment of allowable limits for leachable substances The European Standard EN ISO 10993-17:2002 has the status of a British Standard ICS 11.100 ? Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09
2、:56:43 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 10993-17:2002 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 April 2003 BSI 30 April 2003 ISBN 0 580 41634 8 National foreword This British Standard is the official English langu
3、age version of EN ISO 10993-17:2002. It is identical with ISO 10993-17:2002. The UK participation in its preparation was entrusted to Technical Committee CH/194, Biological evaluation of medical devices, which has the responsibility to: A list of organizations represented on this committee can be ob
4、tained 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 Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facilit
5、y of the BSI Electronic Catalogue or of British 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.
6、aid enquirers to understand the text; present to the responsible international/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. Summary of pages
7、This document comprises a front cover, an inside front cover, the EN ISO title page, the EN ISO foreword page, the ISO title page, pages ii to vi, pages 1 to 25 and a back cover. The BSI copyright date displayed in this document indicates when the document was last issued. Amendments issued since pu
8、blication Amd. No. DateComments Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:56:43 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 10993-17 December 2002 ICS 11.100 English version Biological evaluation of medical devices - Part 17: Es
9、tablishment of allowable limits for leachable substances (ISO 10993- 17:2002) Evaluation biologique des dispositifs mdicaux - Partie 17: Etablissement des limites admissibles des substances relargables (ISO 10993-17:2002) Biologische Beurteilung von Medizinprodukten - Teil 17: Nachweis zulssiger Gre
10、nzwerte fr herauslsbare Bestandteile (ISO 10993-17:2002) This European Standard was approved by CEN on 9 October 2002. 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
11、any alteration. 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
12、 translation 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, Irela
13、nd, Italy, Luxembourg, Malta, 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 2002 CENAll rights of exploitation i
14、n any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 10993-17:2002 E Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:56:43 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Foreword This document (EN ISO 10993-17:2002) has been prepared by Technical Committee I
15、SO/TC 194 “Biological evaluation of medical devices“ in collaboration with Technical Committee CEN/TC 206 “Biocompatibility of medical and dental materials and devices“, the secretariat of which is held by NEN. This European Standard shall be given the status of a national standard, either by public
16、ation of an identical text or by endorsement, at the latest by June 2003, and conflicting national standards shall be withdrawn at the latest by June 2003. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports es
17、sential requirements of EU Directive(s). According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, It
18、aly, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. NOTE FROM CMC The foreword is susceptible to be amended on reception of the German language version. The confirmed or amended foreword, and when appropriate, the normative annex ZA for the refer
19、ences to international publications with their relevant European publications will be circulated with the German version. Endorsement notice The text of ISO 10993-17:2002 has been approved by CEN as EN ISO 10993-17:2002 without any modifications. EN ISO 1099317:2002 Licensed Copy: sheffieldun sheffi
20、eldun, na, Fri Nov 17 09:56:43 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Reference number ISO 10993-17:2002(E) INTERNATIONAL STANDARD ISO 10993-17 First edition 2002-12-01 Biological evaluation of medical devices Part 17: Establishment of allowable limits for leachable substances valuation biologiq
21、ue des dispositifs mdicaux Partie 17: tablissement des limites admissibles des substances relargables EN ISO 1099317:2002 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:56:43 GMT+00:00 2006, Uncontrolled Copy, (c) BSI IS-39901 O71:(2002E) DPlcsid Fremia ihTs PDF file mac ytnoaie nmt dedde
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27、 IS-39901 O71:(2002E) I SO 2002 All irthgs ersedevr iii Contents Page Foreword iv Introduction vi 1 Scope 1 2 Normative reference 1 3 Terms and definitions. 1 4 General principles for establishing allowable limits . 4 5 Establishment of tolerable intake (TI) for specific leachable substances 5 5.1 G
28、eneral. 5 5.2 Exposure considerations for TI calculation . 7 5.3 Collection and evaluation of data 7 5.4 Set TI for noncancer endpoints . 8 5.5 Set TI for cancer endpoints 10 5.6 Establishment of tolerable contact levels (TCLs) 11 5.7 Risk assessment of mixtures. 13 6 Calculation of tolerable exposu
29、re (TE) . 13 6.1 General. 13 6.2 Exposure population. 14 6.3 Calculation of utilization factor from intended use pattern 14 6.4 Tolerable exposure . 15 7 Feasibility evaluation 16 8 Benefit evaluation . 16 9 Allowable limits . 17 10 Reporting requirements 17 Annex A (informative) Some typical assump
30、tions for biological parameters 18 Annex B (informative) Risk assessment for mixtures of leachable substances 20 Annex C (informative) Conversion of allowable limits for systemic exposure and for body surface contact to maximum dose to patient from a medical device 21 Annex D (informative) Risk anal
31、ysis report .23 Bibliography 24 iii EN ISO 1099317:2002 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:56:43 GMT+00:00 2006, Uncontrolled Copy, (c) BSI IS-39901 O71:(2002E) vi I SO 2002 All irthgs ersedevr Foreword ISO (the International Organization for Standardization) is a worldwide fe
32、deration of national standards bodies (ISO member bodies). The work of preparing 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 com
33、mittee. International organizations, governmental and non-governmental, in liaison 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 accord
34、ance with the rules given in the ISO/IEC Directives, Part 3. The main task of technical 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 require
35、s approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this part of ISO 10993 may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 10993-17 was prepared b
36、y Technical Committee ISO/TC 194, Biological evaluation of medical devices. ISO 10993 consists of the following parts, under the general title Biological evaluation of medical devices: Part 1: Evaluation and testing Part 2: Animal welfare requirements Part 3: Tests for genotoxicity, carcinogenicity
37、and reproductive toxicity Part 4: Selection of tests for interactions with blood Part 5: Tests for in vitro cytotoxicity Part 6: Tests for local effects after implantation Part 7: Ethylene oxide sterilization residuals Part 8: Selection and qualification of reference materials for biological tests P
38、art 9: Framework for identification and quantification of potential degradation products Part 10: Tests for irritation and delayed-type hypersensitivity Part 11: Tests for systemic toxicity Part 12: Sample preparation and reference materials Part 13: Identification and quantification of degradation
39、products from polymeric medical devices Part 14: Identification and quantification of degradation products from ceramics Part 15: Identification and quantification of degradation products from metals and alloys Part 16: Toxicokinetic study design for degradation products and leachables iv EN ISO 109
40、9317:2002 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:56:43 GMT+00:00 2006, Uncontrolled Copy, (c) BSI IS-39901 O71:(2002E) I SO 2002 All irthgs ersedevr v Part 17: Establishment of allowable limits for leachable substances Part 18: Chemical characterization of materials Future parts w
41、ill deal with other relevant aspects of biological testing. For the purposes of this part of ISO 10993, the CEN annex regarding fulfilment of European Council Directives has been removed. v EN ISO 1099317:2002 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:56:43 GMT+00:00 2006, Uncontroll
42、ed Copy, (c) BSI IS-39901 O71:(2002E) iv I SO 2002 All irthgs ersedevr Introduction The determination of the suitability of a medical device for a particular use involves balancing any identified risks with the clinical benefit to the patient associated with its use. Among the risks to be considered
43、 are those arising from exposure to leachable substances arising from medical devices. Risks associated with exposure to hazardous leachable substances are managed by identifying the leachable substances, quantifying the associated risks and limiting exposure within tolerable levels. This part of IS
44、O 10993 provides a method by which maximum tolerable levels can be calculated from available data on health risks. Allowable limits may be based upon health risks that can be systemic or local, immediate or delayed, and range in severity from minor localized adverse effects to life-threatening risks
45、. These allowable limits are intended to be derived, using this part of ISO 10993, by toxicologists or other knowledgeable and experienced individuals, capable of making informed decisions based upon scientific data and a knowledge of medical devices. The allowable limits derived may be used by anyo
46、ne. In addition to use by ISO, other standards-developing organizations, government agencies, regulatory bodies, and other users for setting allowable limits as standards or regulations, manufacturers and processors may use the allowable limits derived to optimize processes and aid in the choice of
47、materials in order to protect patient health. Where risks associated with exposure to particular leachable substances are unacceptable, this part of ISO 10993 can be used to qualify alternative materials or processes. vi EN ISO 1099317:2002 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:5
48、6:43 GMT+00:00 2006, Uncontrolled Copy, (c) BSI INTENRATIONAL TSANDADR IS-39901 O71:(2002E) I SO 2002 All irthgs ersedevr 1 Biological evaluation of medical devices Part 17: Establishment of allowable limits for leachable substances 1 Scope This part of ISO 10993 specifies a method for the determina
49、tion of allowable limits for substances leachable from medical devices. It is intended for use in deriving standards and estimating appropriate limits where standards do not exist. It describes a systematic process through which identified risks arising from toxicologically hazardous substances present in medical devices can be quantified. This part of ISO 10993 is not applicable to devices that have no patient contact