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
25、to illuminate any portion of the interior of the eye NOTE Adapted from ISO 15004-2:2007. 3.3 endoilluminator light guide device that transmits light from the endoilluminator light source into the eye 3.4 chandelier endoilluminator light guide intended to be positioned adjacent to the sclera with an
26、output divergence half-angle equal to or greater than 90 3.5 pic forceps device incorporated into the tip of an endoilluminator light guide for tissue manipulation BS EN ISO 15752:2010ISO 15752:2010(E) 2 ISO 2010 All rights reserved3.6 standard (endoilluminator light guide) collimated (endoilluminat
27、or light guide) type of endoilluminator light guide with an output divergence half-angle equal to or less than 40 3.7 wide angle (endoilluminator light guide) diffusing (endoilluminator light guide) type of endoilluminator light guide with an output divergence half-angle greater than 40 but less tha
28、n 90 3.8 endoilluminator light source device that produces and directs light into an endoilluminator light guide 3.9 Group 1 instrument ophthalmic instrument for which no potential light hazard exists and that can be shown to fulfil the requirements of ISO 15004-2:2007, 5.2 NOTE Adapted from ISO 150
29、04-2:2007. 3.10 Group 2 instrument ophthalmic instrument for which a potential light hazard exists and that does not fulfil the requirements of ISO 15004-2:2007, 5.2 NOTE Adapted from ISO 15004-2:2007. 4 Requirements 4.1 Optical radiation hazard with endoilluminator light sources 4.1.1 General Endoi
30、lluminator light sources shall comply with the light hazard protection requirements given in ISO 15004-2. 4.1.2 Determination of classification group The endoilluminator light source shall be classified as a Group 1 or Group 2 instrument as defined in ISO 15004-2:2007, Clause 4. The test methods giv
31、en in Clause 5 of this International Standard, shall be used to make this determination. 4.1.3 Requirements for Group 1 instruments If the status is determined to be Group 1, there are no further requirements. 4.1.4 Requirements for Group 2 instruments If the status is determined to be Group 2, the
32、endoilluminator light source shall comply with the requirements of ISO 15004-2:2007, 5.3 and Clause 7. In addition, Clause 6 of this International Standard shall apply. Compliance with 5.3 of ISO 15004-2:2007 shall be verified using test methods given in Clause 5 of this International Standard. BS E
33、N ISO 15752:2010ISO 15752:2010(E) ISO 2010 All rights reserved 34.2 Retinal protection If the time to reach the aphakic weighted retinal radiant maximum exposure guideline is 30 min at maximum output, a retinal protection means shall be installed in the instrument to increase the time to W 30 min. T
34、he status of the protection means, whether enabled or disabled, shall be clearly evident to the user during surgery. 4.3 Stability of light intensity The endoilluminator light source shall be designed to ensure that, when operated at maximum output, differences in output due to ageing, maintenance,
35、servicing and correctly rated lamp and component replacements cannot reduce the time and/or number of pulses necessary to reach the maximum exposure guideline below the level determined in accordance with ISO 15004-2:2007, 6.5. This shall be applicable throughout the lifetime of the endoilluminator
36、light source when maintained in accordance with the manufacturers specifications. Among other methods, this may be achieved by a risk management process. 5 Test methods 5.1 Determination of irradiance, spectral irradiance and spectrally weighted irradiance for Group 1 and Group 2 instruments For end
37、oilluminators that produce a uniform beam on the retina, with a diameter greater than 1 mm at the recommended use distance, the following shall apply. For the determination of irradiance or spectrally weighted irradiance for standard/collimated light guides, the maximum radiant power or spectrally w
38、eighted radiant power for each light source at maximum intensity shall be determined over an averaging area of 1 mm in diameter at a distance of 15 mm from the exit aperture. For the determination of irradiance or spectrally weighted irradiance for wide-angle/diffusing and chandelier light guides, t
39、he maximum radiant power or spectrally weighted radiant power for each light source at maximum intensity shall be determined over an averaging area of 1 mm in diameter at a distance of 18 mm from the exit aperture. For the determination of irradiance or spectrally weighted irradiance for pic/forceps
40、 light guides, the maximum radiant power or spectrally weighted radiant power for each light source at maximum intensity shall be determined over an averaging area of 1 mm in diameter at a distance of 1 mm from the tip that is intended to be in contact with the macula. A measurement aperture equal t
41、o the diameter of the gauge of the endoilluminator shall be used for endoilluminators that produce a uniform beam on the retina with a diameter of less than 1 mm at the recommended use distance. Where the distance of use is not as specified above, measurements shall be made at the distance specified
42、 by the manufacturer. Measurements shall be made in water or a saline solution. The spectrally weighted retinal irradiance at maximum intensity is equivalent to the value of the maximum spectrally weighted radiant power in a 1 mm diameter area divided by the area (7,9 103cm2). For endoilluminators t
43、hat do not produce a uniform beam on the retina at the recommended use distance, a measurement aperture of 0,03 mm shall be used. BS EN ISO 15752:2010ISO 15752:2010(E) 4 ISO 2010 All rights reserved5.2 Determination of half-angle The output divergence half-angle shall be determined to be the angle a
44、t which the irradiance is equal to one half of the maximum irradiance when evaluated through a 1 mm aperture. The uncertainty in the angle shall be less than 1. A measurement aperture equal to the diameter of the gauge of the endoilluminator shall be used for endoilluminators that produce a uniform
45、beam on the retina with a diameter of less than 1 mm at the recommended use distance. For endoilluminators that do not produce a uniform beam on the retina at the recommended use distance, a measurement aperture of 0,03 mm shall be used. 5.3 Measurements to classify instruments in Group 1 or Group 2
46、 In order to classify instruments in Group 1 or Group 2, 5.1 and 5.2 of this International Standard shall apply, together with ISO 15004-2:2007, 6.1, 6.2 and 6.4. 5.4 Group 2 instrument measurements For Group 2 instrument measurements, 5.1 and 5.2 of this International Standard shall apply, together
47、 with ISO 15004-2:2007, 6.1, 6.3, 6.4, 6.5.1 and 6.5.2. 6 Information supplied by the manufacturer 6.1 General For endoilluminators classified as Group 2, ISO 15004-2:2007, Clause 7, shall apply. 6.2 Information supplied by the manufacturer of Group 2 combination of endoilluminator light source and
48、light guides 6.2.1 Manufacturers of combination endoilluminator light source and light guides shall provide the user with the exposure time(s) required to reach the aphakic weighted safety guideline with the endoilluminator light source set at maximum intensity and 50 % of maximum intensity, with an
49、d without the retinal protection means, for each light guide with which it is intended to be used. These guidelines shall be provided either on the endoilluminator light source or in/on the packaging of each light guide. An example of information to be provided is given in Annex A. 6.2.2 The manufacturer of the endoilluminator light source shall provide the user, upon request, with a graph showing the relative spectral output of the endoilluminator between 320 nm and 1 100 nm, with and without the retinal protection means, when the
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