BS EN ISO 11979-8-2017 Ophthalmic implants Intraocular lenses Fundamental requirements《眼内植入物 隐形眼镜 基本要求》.pdf
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1、Ophthalmic implants Intraocular lensesPart 8: Fundamental requirementsBS EN ISO 119798:2017BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06National forewordThis British Standard is the UK implementation of EN ISO 119798:2017. It supersedes BS EN ISO 119798:2015, whic
2、h is withdrawn.The UK participation in its preparation was entrusted by Technical Committee CH/172, Ophthalmic optics.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contr
3、act. Users are responsible for its correct application. The British Standards Institution 2017 Published by BSI Standards Limited 2017ISBN 978 0 580 93244 1ICS 11.040.70Compliance with a British Standard cannot confer immunity from legal obligations. This British Standard was published under the aut
4、hority of the Standards Policy and Strategy Committee on 30 June 2017.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN ISO 119798:2017EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 119798May 2017ICS 11.040.70 Supersedes EN ISO 119798:2015EUROPEAN COMMITTEE
5、 FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGCENCENELEC Management Centre: Avenue Marnix 17, B1000 Brussels 2017 CEN Ref. No. EN ISO 119798:2017: EAll rights of exploitation in any form and by any means reserved worldwide for CEN national MembersOphthalmic implants
6、 Intraocular lenses Part 8: Fundamental requirements (ISO 119798:2017) Implants ophtalmiques Lentilles intraoculaires Partie 8: Exigences fondamentales (ISO 119798:2017) Ophthalmische Implantate Intraokularlinsen Teil 8: Grundlegende Anforderungen (ISO 119798:2017) This European Standard was approve
7、d by CEN on 8 March 2017.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. Uptodate lists and bibliographical references concerning such national standar
8、ds may be obtained on application to the CENCENELEC 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 translation under the responsibility of a CEN member into its own language and notifi
9、ed to the CEN-CENELEC Management Centre has the same status as the official versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Icela
10、nd, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.English VersionEN ISO 119798:2017 (E)European forewordThis document (EN ISO 119798:2017) has been prepared by Te
11、chnical Committee ISO/TC 172 “Optics and photonics” in collaboration with Technical Committee CEN/TC 170 “Ophthalmic optics” the secretariat of which is held by DIN.This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement,
12、at the latest by November 2017, and conflicting national standards shall be withdrawn at the latest by November 2017.Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying
13、any or all such patent rights.This document supersedes EN ISO 119798:2015 .This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s).For relationship with EU Directive(s), se
14、e informative Annex ZA, which is an integral part of this document.The following referenced documents are indispensable for the application of this document. For undated references, the latest edition of the referenced document (including any amendments) applies. For dated references, only the editi
15、on cited applies. However, for any use of this standard within the meaning of Annex ZA, the user should always check that any referenced document has not been superseded and that its relevant contents can still be considered the generally acknowledged stateofart.When an IEC or ISO standard is referr
16、ed to in the ISO standard text, this shall be understood as a normative reference to the corresponding EN standard, if available, and otherwise to the dated version of the ISO or IEC standard, as listed below.NOTE The way in which these referenced documents are cited in normative requirements determ
17、ines the extent (in whole or in part) to which they apply.Table 1 Correlation between normative references and dated EN and ISO standardsNormative references as listed in Clause 2 of the ISO standardEquivalent dated standardEN ISOISO 119791 EN ISO 119791:2012 ISO 119791:2012 ISO 119792 EN ISO 119792
18、:2014 ISO 119792:2014 ISO 119793 EN ISO 119793:2012 ISO 119793:2012 ISO 119794 EN ISO 119794:2008 + A1:2012 ISO 119794:2008 + Amd.1:2012ISO 119795 EN ISO 119795:2006 ISO 119795:2006 ISO 119796 EN ISO 119796:2014 ISO 119796:2014 ISO 119797 EN ISO 119797:2014 ISO 119797:2014 ISO 119799 EN ISO 119799:2
19、006 + A1:2014 ISO 119799:2006 + Amd.1:2014ISO 1197910 EN ISO 1197910:2006 + A1:2014 ISO 1197910:2006 + Amd.1:2014ISO 14155 EN ISO 14155:2011 + AC:2011 ISO 14155:2011 + Cor.1:2011ISO 14630 EN ISO 14630:2012 ISO 14630:2012 ISO 14971 EN ISO 14971:2012 ISO 14971:2007 According to the CENCENELEC Internal
20、 Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Irela
21、nd, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, iiBS EN ISO 119798:2017EN ISO 119798:2017 (E)Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.Endorsement noticeThe text of ISO 119798:2017 has been approved by CEN a
22、s EN ISO 119798:2017 without any modification.iiiBS EN ISO 119798:2017ISO 119798:2017(E)Foreword v1 Scope . 12 Normative references 13 Terms and definitions . 14 Safety and performance 25 Optical and mechanical properties . 26 Biocompatibility . 27 Clinical evaluation 28 Manufacturing . 29 Steriliza
23、tion . 29.1 General . 29.2 Bacterial endotoxins. 310 Packaging and shelflife 311 Labelling and information 312 Documentation . 3Bibliography 4iv ISO 2017 All rights reservedContents PageBS EN ISO 119798:2017ISO 119798:2017(E)ForewordISO (the International Organization for Standardization) is a world
24、wide 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 which a technical committee has been established has the right to be represented on t
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