BS ISO 10936-1-2017 Optics and photonics Operation microscopes Requirements and test methods《光学和光子学 手术显微镜 要求和试验方法》.pdf

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1、Optics and photonics Operation microscopesPart 1: Requirements and test methodsBS ISO 109361:2017BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06National forewordThis British Standard is the UK implementation of ISO 109361:2017. It supersedes BS ISO 109361:2000, whic

2、h is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CPW/172, Optics and Photonics.A list of organizations represented on this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 c

3、ontract. Users are responsible for its correct application. The British Standards Institution 2017 Published by BSI Standards Limited 2017ISBN 978 0 580 92096 7ICS 37.020; 11.040.30Compliance with a British Standard cannot confer immunity from legal obligations. This British Standard was published u

4、nder the authority of the Standards Policy and Strategy Committee on 30 September 2017.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS ISO 109361:2017 ISO 2017Optics and photonics Operation microscopes Part 1: Requirements and test methodsOptique et photonique Micr

5、oscopes chirurgicaux Partie : Exigences et mthodes dessaiINTERNATIONAL STANDARDISO10936-1Second edition20170801Reference numberISO 109361:2017(E)BS ISO 109361:2017ISO 10936-1:2017(E)ii ISO 2017 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2017, Published in SwitzerlandAll rights reserved. Unl

6、ess otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the

7、address below or ISOs member body in the country of the requester.ISO copyright officeCh. de Blandonnet 8 CP 401CH1214 Vernier, Geneva, SwitzerlandTel. +41 22 749 01 11Fax +41 22 749 09 47copyrightiso.orgwww.iso.orgBS ISO 109361:2017ISO 10936-1:2017(E)Foreword iv1 Scope . 12 Normative references 13

8、Terms and definitions . 14 Requirements 24.1 General . 24.2 Optical and mechanical requirements 24.3 Environmental conditions . 24.4 Safety . 25 Test methods . 25.1 General . 25.2 Checking the optical and mechanical specifications 25.3 Checking the environmental conditions . 25.4 Checking the safety

9、 26 Marking 2Bibliography 4 ISO 2017 All rights reserved iiiContents PageBS ISO 109361:2017ISO 10936-1:2017(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is

10、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 nongovernmental, in liaison with ISO, also take part i

11、n 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/IEC Directives, Part 1. In particular

12、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 possibility that some of the elements of this doc

13、ument 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 patent declarations received (see www.iso.o

14、rg/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 conformity assessment, as well as informatio

15、n 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, Subcommittee SC 5, Microscopes and endoscopes.This

16、 second edition cancels and replaces the first edition (ISO 109361:2000), which has been technically revised. The main changes compared to the previous edition are as follows: the normative references and the title have been updated; note from environmental conditions (4.3) has been removed; safety

17、requirements (4.4) have been updated; the requirement depths of field and total visual magnification (see Table 1) have been clarified.A list of all parts in the ISO 10936 series can be found on the ISO website.iv ISO 2017 All rights reservedBS ISO 109361:2017Optics and photonics Operation microscop

18、es Part 1: Requirements and test methods1 ScopeThis document specifies requirements and refers to test methods for operation microscopes used for observation during surgical operation and treatment of patients.It does not apply to accessories, e.g. photographic cameras.NOTE Specific requirements wit

19、h regard to optical radiation hazards from operation microscopes used in ocular surgery are given in ISO 109362.2 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 document. For dated references, o

20、nly the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 7944, Optics and optical instruments Reference wavelengthsISO 8039, Microscopes Values, tolerances and symbols for magnificationISO 9022 (all parts), Optics and

21、 photonics Environmental test methodsISO 10934 (all parts), Optics and optical instruments Vocabulary for microscopyISO 15227, Optics and optical instruments Microscopes Testing of stereomicroscopesIEC 606011Medical electrical equipment Part 1: General requirements for basic safety and essential per

22、formance3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 8039, ISO 10934 (all parts) and the following apply.ISO and IEC maintain terminological databases for use in standardization at the following addresses: IEC Electropedia: available at http:/www.e

23、lectropedia.org/ ISO Online browsing platform: available at http:/www.iso.org/obp 3.1operation microscopestereomicroscope used for observation of surgical and other medical procedures, consisting of an illumination system and an observation system, including objective lens, variable or fixed power o

24、ptical system, observation tube and eyepiecesEXAMPLE Colposcopes.INTERNATIONAL STANDARD ISO 10936-1:2017(E) ISO 2017 All rights reserved 1BS ISO 109361:2017ISO 10936-1:2017(E)4 Requirements4.1 GeneralThe operation microscope shall conform to the requirements in 4.2, 4.3 and 4.4.All requirements give

25、n below are minimum requirements. They apply to the reference wavelength according to ISO 7944.4.2 Optical and mechanical requirementsThe requirements in Table 1 apply.Testing of optical and mechanical requirements shall be carried out in accordance with 5.2.4.3 Environmental conditionsThe operation

26、 microscope shall conform to the environmental requirements given in IEC 606011.4.4 SafetyThe requirements of IEC 606011 shall apply.5 Test methods5.1 GeneralAll tests specified in this document are type tests.5.2 Checking the optical and mechanical specificationsThe requirements in 4.2 shall be che

27、cked with measuring devices the measuring uncertainty of which shall be smaller than 10 % of the value to be determined in accordance with ISO 15227.Measurements shall be carried out in accordance with general rules of statistical evaluation.5.3 Checking the environmental conditionsTesting of enviro

28、nmental conditions shall be carried out in accordance with ISO 9022 (all parts).5.4 Checking the safetyTesting of safety shall be carried out in accordance with IEC 606011.6 MarkingThe operation microscope shall be permanently marked with at least the markings according to IEC 606011.2 ISO 2017 All

29、rights reservedBS ISO 109361:2017ISO 10936-1:2017(E)Table 1 Requirements for optical and mechanical specificationsCriterion RequirementTolerance of total magnification 7,5 %Difference in magnification between left and right optical systems 1,5 %Difference in axis between left and right optical syste

30、msbvertical 15horizontalaconvergence 45divergence 10Shift of focusing planes by magnification change axial object planeSD03Fc,dFocus difference between left and right optical systemsDDL/RF15,cAt highest magnification the resolving power in the centre of the field should be a minimum of 1800NAline pa

31、irs/mmDifference in imaging rotation between right and left images 2Eyepiece difference in exit pupil height between left and right optical systems 1,5 mm at 0 D on the dioptre scalecalibration error of a dioptre scale, if used 0,25 D at 0 D on the dioptre scaleminimum range for interpupillary dista

32、nce 55 mm to 75 mmminimum adjustment range general +5 D to 5 Dhigh eye point +2 D to 4 DaThis requirement does not apply to those operation microscopes where the mechanical axes of the eyepieces are not parallel to each other due to the design.bIncluding a 10 eyepiece at 0 D adjustment.cThe admissib

33、le axial shift of the focusing plane is determined by:DNAMNAFTOTVIS=+2172whereDFis the depth of field, in millimetres;MTOTVISis the total visual magnification; is the wavelength, in millimetres;NA is the numerical aperture.The second part of this equation is based on the resolution of the eye of 2.d

34、S0is the shift of object plane, in millimetres. ISO 2017 All rights reserved 3BS ISO 109361:2017ISO 10936-1:2017(E)Bibliography1 ISO 109362, Optics and photonics Operation microscopes Part 2: Light hazard from operation microscopes used in ocular surgery2 ISO 11883, Optics and optical instruments Mi

35、croscopes Marking of stereomicroscopes4 ISO 2017 All rights reservedBS ISO 109361:2017This page deliberately left blankBSI is the national body responsible for preparing British Standards and other standards-related publications, information and services.BSI is incorporated by Royal Charter. British

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