EN ISO 10939-2017 en Ophthalmic Instruments - Slit-Lamp Microscopes.pdf

1、Ophthalmic instruments Slit-lamp microscopes (ISO 10939:2017)BS EN ISO 10939:2017BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06National forewordThis British Standard is the UK implementation of EN ISO 10939:2017. It is identical to ISO 10939:2017. It supersedes BS

2、EN ISO 10939:2007, which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/172, Ophthalmic optics.A list of organizations represented on this committee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 necessar

3、y provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2017 Published by BSI Standards Limited 2017ISBN 978 0 580 95192 3ICS 11.040.70Compliance with a British Standard cannot confer immunity from legal obligations. This British Standard was

4、published under the authority of the Standards Policy and Strategy Committee on 31 August 2017.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS EN ISO 10939:2017EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 10939June 2017ICS 11.040.70 Supersedes EN ISO 10939

5、:2007EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGCEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2017 CEN Ref. No. EN ISO 10939:2017: EAll rights of exploitation in any form and by any means reserved worldwide for CEN national Me

6、mbersOphthalmic instruments Slit-lamp microscopes (ISO 10939:2017)Instruments ophtalmiques Microscopes avec lampe fente (ISO 10939:2017)Ophthalmische Instrumente Spaltleuchten (ISO 10939:2017)This European Standard was approved by CEN on 5 March 2017.CEN members are bound to comply with the CEN/CENE

7、LEC 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 concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre o

8、r 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 notified to the CEN-CENELEC Management Centre has the same status as the offi

9、cial 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, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands,

10、Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.English VersionISO 10939:2017(E)Foreword iv1 Scope . 12 Normative references 13 Terms and definitions . 14 Requirements 24.1 General . 24.2 Optical requirements . 24.3 Construction an

11、d function 44.3.1 General 44.3.2 High eye point eyepiece . 44.4 Optical radiation hazard with slit-lamp microscopes . 45 Accompanying documents 56 Marking 5Bibliography 6 ISO 2017 All rights reserved iiiContents PageEN ISO 10939:2017 (E)European forewordThis document (EN ISO 10939:2017) has been pre

12、pared 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 publication of an identical text or by en

13、dorsement, at the latest by December 2017, and conflicting national standards shall be withdrawn at the latest by December 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 i

14、dentifying any or all such patent rights.This document supersedes EN ISO 10939:2007.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 Rep

15、ublic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United King

16、dom.2BS EN ISO 10939:2017ISO 10939:2017(E)Foreword iv1 Scope . 12 Normative references 13 Terms and definitions . 14 Requirements 24.1 General . 24.2 Optical requirements . 24.3 Construction and function 44.3.1 General 44.3.2 High eye point eyepiece . 44.4 Optical radiation hazard with slit-lamp mic

17、roscopes . 45 Accompanying documents 56 Marking 5Bibliography 6 ISO 2017 All rights reserved iiiContents PageBS EN ISO 10939:2017ISO 10939:2017(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of p

18、reparing 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 that committee. International organizations, governmental and non-governmental,

19、in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/I

20、EC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).Attention is drawn to the possibili

21、ty 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. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of pat

22、ent declarations received (see www .iso .org/ patents).Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and expressions related to c

23、onformity assessment, as well as information about ISOs adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: www .iso .org/ iso/ foreword .html.This document was prepared by Technical Committee ISO/TC 172 Optics and photonics, Sub

24、committee SC 7, Ophthalmic optics and instruments.This third edition cancels and replaces the second edition (ISO 10939:2007), of which it constitutes a minor revision with the following changes: technical correction of inconsistency in Table 1, Item No. 9 “Slit image”: “Parallelism of the sides (fo

25、r a slit image of 0,2 mm 8,0 mm)”; update of the dated normative reference to IEC 60601-1:2005 to include the Amendment AMD1: 2012, where appropriate.iv ISO 2017 All rights reservedBS EN ISO 10939:2017ISO 10939:2017(E)ForewordISO (the International Organization for Standardization) is a worldwide fe

26、deration 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 that com

27、mittee. 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 all matters of electrotechnical standardization.The procedures used to develop this document a

28、nd those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Pa

29、rt 2 (see www .iso .org/ directives).Attention is drawn to 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. Details of any patent rights identified during the development o

30、f the document will be in the Introduction and/or on the ISO list of patent declarations received (see www .iso .org/ patents).Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.For an explanation on the voluntary nature of s

31、tandards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: www .iso .org/ iso/ foreword .html.This document

32、was prepared by Technical Committee ISO/TC 172 Optics and photonics, Subcommittee SC 7, Ophthalmic optics and instruments.This third edition cancels and replaces the second edition (ISO 10939:2007), of which it constitutes a minor revision with the following changes: technical correction of inconsis

33、tency in Table 1, Item No. 9 “Slit image”: “Parallelism of the sides (for a slit image of 0,2 mm 8,0 mm)”; update of the dated normative reference to IEC 60601-1:2005 to include the Amendment AMD1: 2012, where appropriate.iv ISO 2017 All rights reserved INTERNATIONAL STANDARD ISO 10939:2017(E)Ophtha

34、lmic instruments Slit-lamp microscopes1 ScopeThis document, together with ISO 15004-1 and ISO 15004-2, specifies requirements and test methods for slit-lamp microscopes to provide slit illumination and observation under magnification of the eye and its adnexa.This document is not applicable to micro

35、scope accessories, e.g. photographic equipment and lasers.This document takes precedence over ISO 15004-1 and ISO 15004-2, if differences exist.2 Normative referencesThe following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this d

36、ocument. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 15004-1, Ophthalmic instruments Fundamental requirements and test methods Part 1: General requirements applicable to all ophthal

37、mic instrumentsISO 15004-2:2007, Ophthalmic instruments Fundamental requirements and test methods Part 2: Light hazard protectionIEC 60601-1:2005+AMD1: 2012, Medical electrical equipment Part 1: General requirements for basic safety and essential performance3 Terms and definitionsFor the purposes of

38、 this document, the following terms and definitions apply.ISO and IEC maintain terminological databases for use in standardization at the following addresses: IEC Electropedia: available at h t t p :/ www .electropedia .org/ ISO Online browsing platform: available at h t t p :/ www .iso .org/ obp3.1

39、slit-lamp microscopeinstrument consisting of a microscope and a swivelling illumination system providing a slit image3.2magnificationratio of the viewing angle of an object, when observed through a magnifying system with the image at infinity, to that of the object, when observed by the naked eye at

40、 a reference viewing distance of 250 mmNote 1 to entry: The magnification, , can be calculated using the following formula: =tan tan ISO 2017 All rights reserved 1BS EN ISO 10939:2017ISO 10939:2017(E)where is the angle at which an object is seen through the microscope; is the angle at which the same

41、 object is seen without any instrument at a viewing distance of 250 mm.Note 2 to entry: The magnification of the microscope comprises the magnifications of the complete system.3.3high eye point eyepieceeyepiece in which the exit pupil is of sufficient clearance from the eyepiece to allow spectacles

42、to be worn4 Requirements4.1 GeneralThe slit-lamp microscope shall conform to the requirements specified in ISO 15004-1 and ISO 15004-2.The slit-lamp microscope shall conform to the requirements specified in 4.2, 4.3 and 4.4. Compliance with these requirements is verified by type testing.4.2 Optical

43、requirementsThe slit-lamp microscope shall conform to the requirements given in Table 1. These requirements shall be verified by use of measuring devices whose measuring errors are smaller than 10 % of the smallest value to be determined.Test results shall be evaluated in accordance with general rul

44、es of statistics.Table 1 Requirements for optical propertiesNo. Criterion Requirement1 Permissible tolerance of microscope magnification (see 3.2) 5 %2 Difference in magnification between left and right observation systems 3 %aWith the eyepiece for which the slit-lamp microscope is designed.bThis re

45、quirement does not apply to those slit-lamp microscopes where, due to the design, the mechanical axes of the eyepieces are not parallel to each other.cFor explanation of criterion No. 5, see Figure 1.dDepth of field, expressed in millimetres:dNN=+2101726whereN is the numerical aperture; is the total

46、 magnification of the microscope (see 3.2); is the reference wavelength in accordance with ISO 7944, expressed in nanometres.ex is a weighting factor.2 ISO 2017 All rights reservedBS EN ISO 10939:2017ISO 10939:2017(E)where is the angle at which an object is seen through the microscope; is the angle

47、at which the same object is seen without any instrument at a viewing distance of 250 mm.Note 2 to entry: The magnification of the microscope comprises the magnifications of the complete system.3.3high eye point eyepieceeyepiece in which the exit pupil is of sufficient clearance from the eyepiece to

48、allow spectacles to be worn4 Requirements4.1 GeneralThe slit-lamp microscope shall conform to the requirements specified in ISO 15004-1 and ISO 15004-2.The slit-lamp microscope shall conform to the requirements specified in 4.2, 4.3 and 4.4. Compliance with these requirements is verified by type tes

49、ting.4.2 Optical requirementsThe slit-lamp microscope shall conform to the requirements given in Table 1. These requirements shall be verified by use of measuring devices whose measuring errors are smaller than 10 % of the smallest value to be determined.Test results shall be evaluated in accordance with general rules of statistics.Table 1 Requirements for optical propertiesNo. Criterion Requirement1 Permissible tolerance of microscope magnification (see 3.2) 5 %2 Difference in magnification between