BS-EN-ISO-11979-5-2006.pdf
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1、BRITISH STANDARD BS EN ISO 11979-5:2006 Ophthalmic implants Intraocular lenses Part 5: Biocompatibility The European Standard EN ISO 11979-5:2006 has the status of a British Standard ICS 11.040.70 ? Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 10:08:03 GMT+00:00 2006, Uncontrolled Copy, (c
2、) BSI BS EN ISO 11979-5:2006 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 June 2006 BSI 2006 ISBN 0 580 48582 X National foreword This British Standard is the official English language version of EN ISO 11979-5:2006. It is identical wit
3、h ISO 11979-5:2006. It supersedes BS EN 13503-5:2001 which is withdrawn. The UK participation in its preparation was entrusted by Technical Committee CH/172, Ophthalmic optics, to Subcommittee CH/172/7, Eye implants, which has the responsibility to: A list of organizations represented on this subcom
4、mittee can be obtained 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
5、“Search” facility 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 leg
6、al obligations. aid enquirers to 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. Summa
7、ry of pages 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 v, a blank page, pages 1 to 24, an inside back cover and a back cover. The BSI copyright notice displayed in this document indicates when the doc
8、ument was last issued. Amendments issued since publication Amd. No. DateComments Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 10:08:03 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11979-5 June 2006 ICS 11.040.70Supersedes EN 13503-5:20
9、01 English Version Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2006) Implants ophtalmiques - Lentilles intraoculaires - Partie 5: Biocompatibilit (ISO 11979-5:2006) Ophthalmische Implantate - Intraokularlinsen - Teil 5: Biokompatibilitt (ISO 11979-5:2006) This Eu
10、ropean Standard was approved by CEN on 13 April 2006. 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 c
11、oncerning 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, Luxem
13、bourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, 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 2006 CENAll rig
14、hts of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11979-5:2006: E Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 10:08:03 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Foreword This document supersedes EN 13503-5:2001. According to the
15、 CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerlan
16、d and United Kingdom. Endorsement notice text or by endorsement, at the latest by December 2006, and conflicting national standards shall be withdrawn This document (EN ISO 11979-5:2006) has been prepared by Technical Committee ISO/TC 172 “Optics and optical instruments“ in collaboration with Techni
17、cal Committee CEN/TC 170 “Ophthalmic optics“, the secretariat of which is held by DIN. at the latest by December 2006. This European Standard shall be given the status of a national standard, either by publication of an identical Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
18、Ireland, Italy, Latvia, Lithuania, The text of ISO 11979-5:2006 has been approved by CEN as EN ISO 11979-5:2006 without any modifications. EN ISO 11979-5:2006 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 10:08:03 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Reference number ISO 11979-5:2006(
19、E) INTERNATIONAL STANDARD ISO 11979-5 Second edition 2006-06-01 Ophthalmic implants Intraocular lenses Part 5: Biocompatibility Implants ophtalmiques Lentilles intraoculaires Partie 5: Biocompatibilit EN ISO 11979-5:2006 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 10:08:03 GMT+00:00 2006,
20、 Uncontrolled Copy, (c) BSI ii Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 10:08:03 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iii Contents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references. 1 3 Terms and definitions. 1 4 General requirements applying to biocompatibility
21、evaluation of intraocular lenses. 2 5 Physicochemical tests . 2 6 Biological tests . 5 Annex A (normative) Exhaustive extraction test 7 Annex B (normative) Test for leachables 10 Annex C (normative) Hydrolytic stability. 12 Annex D (normative) Photostability test 15 Annex E (normative) Nd-YAG laser
22、exposure test . 17 Annex F (informative) Supplemental conditions of test for local effects after implantation 19 Annex G (normative) Ocular implantation test . 20 Bibliography. 24 EN ISO 11979-5:2006 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 10:08:03 GMT+00:00 2006, Uncontrolled Copy, (
23、c) BSI iv Foreword ISO (the International Organization for Standardization) is a worldwide federation 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
24、 which a technical committee has been established has the right to be represented on that committee. 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 a
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