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1、BRITISH STANDARD BS EN ISO 10993-13:1999 Biological evaluation of medical devices Part 13: Identification and quantification of degradation products from polymeric medical devices The European Standard EN ISO 10993-13:1998 has the status of a British Standard ICS 11.100 Licensed Copy: sheffieldun sh
2、effieldun, na, Wed Nov 15 13:09:04 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 10993-13:1999 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
3、15th February 1999 BSI 05-1999 ISBN 0 580 30969 X National foreword This British Standard is the English language version of EN ISO 10993-13:1998. It is identical with ISO 10993-13:1998. The UK participation in its preparation was entrusted to Technical Committee CH/26, Biological testing of medical
4、 and dental materials and devices, which has the responsibility to: 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 Eu
5、ropean developments and promulgate them in the UK. A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references Attention is drawn to the fact that CEN and CENELEC Standards normally include an annex which lists normative references to internati
6、onal publications with their corresponding European publications. The British Standards which implement international or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by usi
7、ng 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 application. Compliance with a British Standard does not of itself confer immunity
8、 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, page 2, the ISO title page, pages ii to iv, pages 1 to 8 and a back cover. This standard has been updated (see copyright date) and may have had amendments in
9、corporated. 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 13:09:04 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 10993-13:1999 BSI 05-1999i Contents Page
10、National forewordInside front cover Foreword 2 Foreword ii Text of ISO 10993-131 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:09:04 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii blank Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:09:04 GMT+00:00 2006, Uncontrolled Copy, (c)
11、BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 10993-13 November 1998 ICS 11.100 Descriptors: English version Biological evaluation of medical devices Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:1998) Evaluation biolog
12、ique des dispositifs mdicaux Partie 13: Identification et quantification de produits de dgradation de dispositifs mdicaux base de polymres (ISO 10993-13:1998) Biologische Beurteilung von Medizinprodukten Teil 13: Qualitativer und quantitativer Nachweis von Abbauprodukten in Medizinprodukten aus Poly
13、meren (ISO 10993-13:1998) This European Standard was approved by CEN on 15 November 1998. 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 li
14、sts and bibliographical references 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 resp
15、onsibility of a CEN member into its 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, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Ne
16、therlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. CEN European Committee for Standardization Comit Europen de Normalisation Europisches Komitee fr Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1998 CEN All rights of exploitation in any form and by any mea
17、ns reserved worldwide for CEN national Members. Ref. No. EN ISO 10993-13:1998 E Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:09:04 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 10993-13:1998 BSI 05-1999 2 Foreword The text of the International Standard ISO 10993-13:1998 has been pre
18、pared by Technical Committee ISO/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 NNI. This European Standard shall be given the status of a natio
19、nal 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 1998. This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Fr
20、ee Trade Association, and supports essential 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,
21、Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of the International Standard ISO 10993-13:1998 was approved by CEN as a European Standard without any modification. NOTENormative refer
22、ences to International Standards are listed in Annex ZA (normative). Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:09:04 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:09:04 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 10993-13:1
23、998 ii BSI 05-1999 Contents Page Forewordii Introduction1 1 Scope1 2 Normative references1 3 Definitions1 4 Degradation test methods2 4.1 General procedures2 4.2 Accelerated degradation test4 4.3 Real-time degradation test4 5 Test procedures4 5.1 Initial material characterization4 5.2 Accelerated de
24、gradation test4 5.3 Real-time degradation test6 6 Test report6 Annex A (informative) Analytical methods7 Annex ZA (normative) Normative references to international publications with their relevant European publications8 Table 15 Descriptors: Medical equipment, medical devices, polymers, plastics pro
25、ducts, tests, biological tests, determination, deterioration. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:09:04 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 10993-13:1998 BSI 05-1999iii Foreword ISO (the International Organization for Standardization) is a worldwide federation of
26、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 committee. Inte
27、rnational 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. Draft International Standards adopted by the technical co
28、mmittees 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. International Standard ISO 10993-13 was prepared by Technical Committee ISO/TC 194, Biological evaluation of medical devices. ISO
29、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 4: Selection of tests for interactions with bl
30、ood; Part 5: Tests for cytotoxicity: in vitro methods; Part 6: Tests for local effects after implantation; Part 7: Ethylene oxide sterilization residuals; Part 9: Framework for the identification and quantification of potential degradation products; Part 10: Tests for irritation and sensitization; P
31、art 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 ceramics; Part 15: Identification and q
32、uantification of degradation products from metals and alloys; Part 16: Toxicokinetic study design for degradation products and leachables. Annex A of this part of ISO 10993 is for information only. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:09:04 GMT+00:00 2006, Uncontrolled Copy, (c)
33、 BSI iv blank Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:09:04 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 10993-13:1998 BSI 05-19991 Introduction This part of ISO 10993 was developed from ISO/TR 10993-9. Degradation products covered by this standard are formed primarily by chem
34、ical bond scission due to hydrolytic and/or oxidative processes in an aqueous environment. It is recognized that additional biological factors, such as enzymes, other proteins and cellular activity, can alter the rate and nature of degradation. It should be kept in mind that a polymeric device may c
35、ontain residuals and leachables such as monomers, oligomers, solvents, catalysts, additives, fillers and processing aids. These components which, if present, may interfere with the identification and quantification of the degradation products, need to be considered and accounted for. It should be re
36、cognized that residual monomers may generate the same degradation products as the polymer itself. The identified and quantified degradation products form the basis for biological evaluation in accordance with ISO 10993-1, for risk assessment in accordance with ISO 14538 and, if appropriate, for toxi
37、cokinetic studies in accordance with ISO 10993-16. 1 Scope This part of ISO 10993 provides guidance on general requirements for the design of tests for identifying and quantifying degradation products from finished polymeric medical devices ready for clinical use. This part of ISO 10993 describes tw
38、o test methods to generate degradation products, an accelerated degradation test as a screening method and a real-time degradation test. For materials which are intended to polymerize in situ, the set or cured polymer is used for testing. The data generated are used in the biological evaluation of t
39、he polymer. This part of ISO 10993 considers only those degradation products generated by a chemical alteration of the finished polymeric device. It is not applicable to degradation of the device induced during its intended use by mechanical stress, wear or electromagnetic radiation. The biological
40、activity of the debris and soluble degradation products is not addressed in this part of ISO 10993, but should be evaluated according to the principles of ISO 10993-1 and ISO 14538. Because of the wide range of polymeric materials used in medical devices, no specific analytical techniques are identi
41、fied or given preference. No specific requirements for acceptable levels of degradation products are provided in this part of ISO 10993. 2 Normative references The following standards contain provisions which, through reference in this text, constitute provisions of this part of ISO 10993. At the ti
42、me of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on this part of ISO 10993 are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below. Members of IEC and ISO maintain
43、registers of currently valid International Standards. ISO 3696:1987, Water for analytical laboratory use Specification and test methods. ISO 10993-1:1997, Biological evaluation of medical devices Part 1: Evaluation and testing. ISO 10993-9:, Biological evaluation of medical devices Part 9: Framework
44、 for identification and quantification of potential degradation products1). ISO 10993-12:1996, Biological evaluation of medical devices Part 12: Sample preparation and reference materials. ISO 10993-16:1997, Biological evaluation of medical devices Part 16: Toxicokinetic study design for degradation
45、 products and leachables. ISO 13781:1997, Poly(L-lactide) resins and fabricated forms for surgical implants In vitro degradation testing. ISO 14538:, Biological evaluation of medical devices Establishment of permissible limits for sterilization and process residues using health-based risk assessment
46、1). 3 Definitions For the purposes of this part of ISO 10993, the definitions given in ISO 10993-1, ISO 10993-9, ISO 13781 and the following definitions apply. 3.1 residual monomer unreacted chemical compound(s) used to build the polymeric chains and still present in the final polymeric material 1)
47、To be published. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:09:04 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 10993-13:1998 2 BSI 05-1999 3.2 degradation product chemical compound derived from the breakdown of the polymeric material, including any compound produced by consecutiv
48、e chemical reactions 3.3 polymeric material materials consisting of long-chain and/or crosslinked molecules composed of units called monomers 3.4 hydrolytic degradation scission of chemical bonds in a polymer by the attack of water NOTEThe water may have a neutral, acidic or alkaline pH value and ma
49、y contain additional chemical compounds or ions. 3.5 oxidative degradation scission of chemical bonds in a polymer by the attack of oxidizing agent(s) 3.6 debris particulate material produced by the degradation of a polymeric material 4 Degradation test methods 4.1 General procedures 4.1.1 Test design In accordance with ISO 10993-9, degradation tests shall be used to generate, identify and/or quantify degradation products. If degradation is observed in an accelerated test, identification and quantification
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