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1、BRITISH STANDARD BS EN ISO 10993-18:2005 Biological evaluation of medical devices Part 18: Chemical characterization of materials The European Standard EN ISO 10993-18:2005 has the status of a British Standard ICS 11.100.20 ? Licensed Copy: sheffieldun sheffieldun, na, Sat Nov 18 01:32:48 GMT+00:00
2、2006, Uncontrolled Copy, (c) BSI BS EN 10993-18:2005 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 17 November 2005 BSI 17 November 2005 ISBN 0 580 46599 3 National foreword This British Standard is the official English language version of
3、EN ISO 10993-18:2005. It is identical with ISO 10993-18:2005. 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 obtained on reque
4、st 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” facility of the BSI El
5、ectronic 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. aid enquirers t
6、o understand the text; present to 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 compr
7、ises 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 18, an inside back cover and a back cover. The BSI copyright date displayed in this document indicates when the document was last issued. Amendments issued since
8、 publication Amd. No. DateComments Licensed Copy: sheffieldun sheffieldun, na, Sat Nov 18 01:32:48 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 10993-18 July 2005 ICS 11.100.20 English Version Biological evaluation of medical devices - Part 18:
9、Chemical characterization of materials (ISO 10993-18:2005) Evaluation biologique des dispositifs mdicaux - Partie 18: Caractrisation chimique des matriaux (ISO 10993- 18:2005) Biologische Beurteilung von Medizinprodukten - Teil 18: Chemische Charakterisierung von Werkstoffen (ISO 10993-18:2005) This
10、 European Standard was approved by CEN on 6 June 2005. 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
11、concerning such national standards may be obtained 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
12、 own language and notified to the Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxe
13、mbourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, 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 2005 CEN All rights of
14、exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 10993-18:2005: E Licensed Copy: sheffieldun sheffieldun, na, Sat Nov 18 01:32:48 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Foreword This document (EN ISO 10993-18:2005) has been prepared by Techni
15、cal Committee CEN/TC 206 “Biocompatibility of medical and dental materials and devices“, the secretariat of which is held by NEN, in collaboration with Technical Committee ISO/TC 194 “Biological evaluation of medical devices“. This European Standard shall be given the status of a national standard,
16、either by publication of an identical text or by endorsement, at the latest by January 2006, and conflicting national standards shall be withdrawn at the latest by January 2006. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Associ
17、ation, 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 document. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to
18、implement this European Standard: 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 and United Kin
19、gdom. Endorsement notice The text of ISO 10993-18:2005 has been approved by CEN as EN ISO 10993-18:2005 without any modifications. EN ISO 10993-18:2005 Licensed Copy: sheffieldun sheffieldun, na, Sat Nov 18 01:32:48 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Reference number ISO 10993-18:2005(E) INT
20、ERNATIONAL STANDARD ISO 10993-18 First edition 2005-07-01 Biological evaluation of medical devices Part 18: Chemical characterization of materials valuation biologique des dispositifs mdicaux Partie 18: Caractrisation chimique des matriaux EN ISO 10993-18:2005 Licensed Copy: sheffieldun sheffieldun,
21、 na, Sat Nov 18 01:32:48 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii Licensed Copy: sheffieldun sheffieldun, na, Sat Nov 18 01:32:48 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 10993-18:2005 iii Contents Page Foreword iv Introduction . vi 1 Scope . 1 2 Normative references . 1 3 Terms and de
22、finitions. 2 4 Symbols and abbreviated terms . 3 5 General principles. 3 6 Characterization procedure . 4 6.1 General. 4 6.2 Step 1 Qualitative information 5 6.3 Step 2 Material equivalence 5 6.4 Step 3 Quantitative information 5 6.5 Step 4 Quantitative risk assessment 5 6.6 Step 5 Estimated clinica
23、l exposure to chemicals present . 6 7 Chemical characterization parameters and methods . 6 7.1 General. 6 7.2 Polymers 7 7.3 Metals and alloys 8 7.4 Ceramics 8 7.5 Natural macromolecules 9 8 Reporting of data obtained 10 Annex A (normative) Flowchart summarizing the stepwise generation of chemical c
24、haracterization data for use in toxicological risk assessment 11 Annex B (informative) Information sources for chemical characterization . 13 Annex C (informative) Principles for judging toxicological equivalency . 16 Bibliography . 17 Annex ZA (informative) Relationship between this European Standa
25、rd and the Essential Requirements of EU Directive 93/42 EEC .18 Licensed Copy: sheffieldun sheffieldun, na, Sat Nov 18 01:32:48 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 10993-18:2005 iv Foreword ISO (the International Organization for Standardization) is a worldwide federation of national s
26、tandards 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 committee. International
27、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 accordance with the rules gi
28、ven in the ISO/IEC Directives, Part 2. 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 requires approval by at least
29、 75 % of the member bodies casting a vote. Attention is drawn 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 10993-18 was prepared by Technical Committee ISO/TC 19
30、4, 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 and reproductive toxicity Part
31、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 9: Framework for identification and quantification of potential degradation products Part 10: Tests for irr
32、itation and delayed-type hypersensitivity Part 11: Tests for systemic toxicity Part 12: Sample preparation and reference materials Part 13: Identification and quantification of degradation products from polymeric medical devices Part 14: Identification and quantification of degradation products from
33、 ceramics Part 15: Identification and quantification of degradation products from metals and alloys Part 16: Toxicokinetic study design for degradation products and leachables Part 17: Establishment of allowable limits for leachable substances Licensed Copy: sheffieldun sheffieldun, na, Sat Nov 18 0
34、1:32:48 GMT+00:00 2006, Uncontrolled Copy, (c) BSI v Part 18: Chemical characterization of materials The following parts are under preparation: Part 19: Physico-chemical, mechanical and morphological characterization Part 20: Principles and methods for immunotoxicology testing of medical devices Fut
35、ure parts will 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. EN ISO 10993-18:2005 Licensed Copy: sheffieldun sheffieldun, na, Sat Nov 18 01:32:48 GMT+00:00 2006,
36、Uncontrolled Copy, (c) BSI vi Introduction ISO 10993-1 provides a framework for a structured programme of assessment for the evaluation of biological safety. Clause 3 of ISO 10993-1:2003 states that in the selection of materials to be used for device manufacture the first consideration should be fit
37、ness for purpose. This should have regard to the characteristics and properties of the material, which include chemical, toxicological, physical, electrical, morphological and mechanical properties. This information is necessary prior to any biological evaluation. Subclause 7.2 of ISO 10993-1:2003 n
38、otes that the continuing acceptability of a biological evaluation is an aspect of a quality management system. Also ISO 14971 points out that a toxicological risk analysis should take account of the chemical nature of the materials. The requirements specified in this document are intended to yield t
39、he following information, which will be of value in predicting the biological response of the materials: The chemical composition of the materials used in the manufacturing process including processing additives and residues e.g. trace chemicals, cleaning, disinfection and testing agents, acids and
40、caustic substances. The characterization of materials to be used in the production of medical devices, as well as in devices in their final form. Identification of the materials of construction of the medical device. The potential of medical device materials to release substances or breakdown produc
41、ts due to the manufacturing process. Changes in the materials of construction, which result from changes in the manufacturing process or insufficient control of the manufacturing process. The compositional characteristics of the materials of manufacture are mainly under the control of the suppliers
42、of these materials. However other characteristics are chiefly influenced by the requirements to be met by the finished medical device as well as the processes used by the medical device manufacturer. EN ISO 10993-18:2005 Licensed Copy: sheffieldun sheffieldun, na, Sat Nov 18 01:32:48 GMT+00:00 2006,
43、 Uncontrolled Copy, (c) BSI 1 Biological evaluation of medical devices Part 18: Chemical characterization of materials 1 Scope This part of ISO 10993 describes a framework for the identification of a material and the identification and quantification of its chemical constituents. The chemical charac
44、terization information generated can be used for a range of important applications, for example: As part of an assessment of the overall biological safety of a medical device (ISO 10993-1 and 14971). Measurement of the level of a leachable substance in a medical device in order to allow the assessme
45、nt of compliance with the allowable limit derived for that substance from health based risk assessment (ISO 10993-17). Judging equivalence of a proposed material to a clinically established material. Judging equivalence of a final device to a prototype device to check the relevance of data on the la
46、tter to be used to support the assessment of the former. Screening of potential new materials for suitability in a medical device for a proposed clinical application. This part of ISO 10993 does not address the identification or quantification of degradation products, which is covered in ISO 10993-9
47、, ISO 10993-13, ISO 10993-14 and ISO 10993-15. The ISO 10993 series of standards is applicable when the material or device comes into contact with the body directly or indirectly (see 4.2.1 of ISO 10993-1:2003). This part of ISO 10993 is intended for suppliers of materials and manufacturers of medic
48、al devices, when carrying out a biological safety assessment. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document
49、(including any amendments) applies. ISO 10993-1:2003, Biological evaluation of medical devices Part 1: Evaluation and testing ISO 10993-17, Biological evaluation of medical devices Part 17: Establishment of allowable limits for leachable substances ISO 14971:2000, Medical devices Application of risk management to medical devices EN ISO 10993-18:2005 Licensed Copy: sheffieldun sheffieldun, na, Sat Nov 18 01:32:48 GMT+00