BS EN ISO 15752-2010 Ophthalmic instruments - Endoilluminators - Fundamental requirements and test methods for optical radiation safety《眼科仪器 内发光器 光辐射安全的基本要求和试验方法》.pdf
《BS EN ISO 15752-2010 Ophthalmic instruments - Endoilluminators - Fundamental requirements and test methods for optical radiation safety《眼科仪器 内发光器 光辐射安全的基本要求和试验方法》.pdf》由会员分享,可在线阅读,更多相关《BS EN ISO 15752-2010 Ophthalmic instruments - Endoilluminators - Fundamental requirements and test methods for optical radiation safety《眼科仪器 内发光器 光辐射安全的基本要求和试验方法》.pdf(14页珍藏版)》请在麦多课文档分享上搜索。
1、BS EN ISO15752:2010ICS 11.040.70NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDOphthalmicinstruments Endoilluminators Fundamentalrequirements and testmethods for opticalradiation safety (ISO15752:2010)This British Standardwas published under theauthority of the
2、 StandardsPolicy and StrategyCommittee on 28 February2010 BSI 2010ISBN 978 0 580 59210 2Amendments/corrigenda issued since publicationDate CommentsBS EN ISO 15752:2010National forewordThis British Standard is the UK implementation of EN ISO 15752:2010.It supersedes BS ISO 15752:2000 which is withdra
3、wn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/172/6, Ophthalmic instruments.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisionsof a contract. Use
4、rs are responsible for its correct application.Compliance with a British Standard cannot confer immunityfrom legal obligations.EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 15752 January 2010 ICS 11.040.70 English Version Ophthalmic instruments - Endoilluminators - Fundamental requirement
5、s and test methods for optical radiation safety (ISO 15752:2010) Instruments ophtalmiques - Sondes endolumineuses - Exigences fondamentales et mthodes dessai relatives la scurit vis-vis des rayonnements optiques (ISO 15752:2010) Ophthalmische Instrumente - Endoilluminatoren - Grundlegende Anforderun
6、gen und Prfverfahren in Bezug auf die optische Strahlungssicherheit (ISO 15752:2010) This European Standard was approved by CEN on 9 January 2010. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of
7、a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A versi
8、on in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Repu
9、blic, Denmark, Estonia, Finland, 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
10、 NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2010 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 15752:2010: EBS EN ISO 15752:2010EN ISO 15752:2010 (E) 3 Foreword This docu
11、ment (EN ISO 15752:2010) has been prepared by Technical 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 pu
12、blication of an identical text or by endorsement, at the latest by July 2010, and conflicting national standards shall be withdrawn at the latest by July 2010. 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 sha
13、ll not be held responsible for identifying any or all such patent rights. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Den
14、mark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 15752:2010 has been appro
15、ved by CEN as a EN ISO 15752:2010 without any modification. BS EN ISO 15752:2010ISO 15752:2010(E) ISO 2010 All rights reserved iiiForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing Intern
16、ational 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 organizations, governmental and non-governmental, in liaison with
17、 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 given in the ISO/IEC Directives, Part 2. The main task of technical
18、 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 75 % of the member bodies casting a vote. Attention is drawn to
19、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 15752 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 7, Ophthalmic optics and in
20、struments. This second edition cancels and replaces the first edition (ISO 15752:2000), which has been technically revised. BS EN ISO 15752:2010BS EN ISO 15752:2010INTERNATIONAL STANDARD ISO 15752:2010(E) ISO 2010 All rights reserved 1Ophthalmic instruments Endoilluminators Fundamental requirements
21、and test methods for optical radiation safety 1 Scope This International Standard specifies optical radiation safety aspects of endoilluminator light sources and endoilluminator light guides which are used to illuminate the interior of the eye during ocular surgery. 2 Normative references The follow
22、ing 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 (including any amendments) applies. ISO 15004-2:2007, Ophthalmic instruments Fundamental requir
23、ements and test methods Part 2: Light hazard protection IEC 60601-1, Medical electrical equipment Part 1: General requirements for basic safety and essential performance 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 15004-2 and the following apply.
24、 3.1 exit aperture portion of the endoilluminator light guide from which light from the endoilluminator light source emerges 3.2 endoilluminator device consisting of an endoilluminator light source and an associated fibre-optic endoilluminator light guide that is intended for insertion into the eye
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