BS-EN-ISO-11979-3-2006.pdf
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1、BRITISH STANDARD BS EN ISO 11979-3:2006 Ophthalmic implants Intraocular lenses Part 3: Mechanical properties and test methods The European Standard EN ISO 11979-3:2006 has the status of a British Standard ICS 11.040.70 ? Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 10:07:51 GMT+00:00 2006,
2、 Uncontrolled Copy, (c) BSI BS EN ISO 11979-3:2006 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 May 2006 BSI 2006 ISBN 0 580 48377 0 National foreword This British Standard is the official English language version of EN ISO 11979-3:2006
3、. It is identical with ISO 11979-3:2006. It supersedes BS EN 13503-3:2000 which is withdrawn.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 repre
4、sented on this subcommittee 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 Ind
5、ex”, or by using the “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 con
6、fer immunity from legal 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
7、them in the UK. Summary 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 30, an inside back cover and a back cover. The BSI copyright notice displayed in this document i
8、ndicates when the document was last issued. Amendments issued since publication Amd. No. DateComments Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 10:07:51 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11979-3 May 2006 ICS 11.040.70Supe
9、rsedes EN 13503-3:2000 English Version Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods (ISO 11979-3:2006) Implants ophtalmiques - Lentilles intraoculaires - Partie 3: Proprits mcaniques et mthodes dessai (ISO 11979- 3:2006) Ophthalmische Implantate - Intraok
10、ularlinsen - Teil 3: Mechanische Eigenschaften und Prfverfahren (ISO 11979-3:2006) This European 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 n
11、ational standard without any alteration. Up-to-date lists 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
12、 any other language made by translation under the responsibility 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, Cyprus, Czech Republic, Denmark, Estonia, Fi
13、nland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES
14、 KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2006 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11979-3:2006: E Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 10:07:51 GMT+00:00 2006, Unco
15、ntrolled Copy, (c) BSI Foreword This document (EN ISO 11979-3:2006) has been prepared by Technical Committee ISO/TC 172 “Optics and optical instruments“ in collaboration with Technical Committee CEN/TC 170 “Ophthalmic optics“, the secretariat of which is held by DIN. This European Standard shall be
16、given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by November 2006, and conflicting national standards shall be withdrawn at the latest by November 2006. This document supersedes EN 13503-3:2000. According to the CEN/CENELEC Internal
17、 Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlan
18、ds, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Endorsement notice The text of ISO 11979-3:2006 has been approved by CEN as EN ISO 11979-3:2006 without any modifications. EN ISO 11979-3:2006 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov
19、 17 10:07:51 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Reference number ISO 11979-3:2006(E) INTERNATIONAL STANDARD ISO 11979-3 Second edition 2006-05-01 Ophthalmic implants Intraocular lenses Part 3: Mechanical properties and test methods EN ISO 11979-3:2006 Licensed Copy: sheffieldun sheffieldun,
20、na, Fri Nov 17 10:07:51 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 10:07:51 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 Requirement
21、s 1 4.1 General. 1 4.2 Tolerances and dimensions 2 4.3 Clearance analysis 2 4.4 Compression force. 2 4.5 Axial displacement in compression 3 4.6 Optic decentration 3 4.7 Optic tilt . 3 4.8 Angle of contact 3 4.9 Compression force decay 3 4.10 Dynamic fatigue durability. 3 4.11 Surgical manipulation
22、4 4.12 Surface and bulk homogeneity . 4 5 Recovery of properties following simulated surgical manipulation . 4 Annex A (normative) Measurement of compression force 5 Annex B (normative) Measurement of axial displacement in compression 9 Annex C (normative) Measurement of optic decentration. 12 Annex
23、 D (normative) Measurement of optic tilt 15 Annex E (normative) Measurement of angle of contact. 18 Annex F (normative) Testing of compression force decay 21 Annex G (normative) Testing of dynamic fatigue durability 22 Annex H (informative) Measurement of loop pull strength 24 Annex I (informative)
24、Clearance analysis 26 Annex J (informative) Precision 29 Bibliography. 30 EN ISO 11979-3:2006 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 10:07:51 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iv Foreword ISO (the International Organization for Standardization) is a worldwide federation of n
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