BS ISO 10936-2-2010 Optics and photonics - Operation microscopes - Light hazard from operation microscopes used in ocular surgery《光学和光学仪器 手术显微镜 眼外科手术用手术显微镜的光危险》.pdf

1、BS ISO10936-2:2010ICS 11.040.30; 37.020NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDOptics and photonics Operation microscopesPart 2: Light hazard from operationmicroscopes used in ocular surgeryThis British Standardwas published under theauthority of the Sta

2、ndardsPolicy and StrategyCommittee on 28 February2010. BSI 2010ISBN 978 0 580 58855 6Amendments/corrigenda issued since publicationDate CommentsBS ISO 10936-2:2010National forewordThis British Standard is the UK implementation of ISO 10936-2:2010. Itsupersedes BS ISO 10936-2:2001 which is withdrawn.

3、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. Users

4、are responsible for its correct application.Compliance with a British Standard cannot confer immunityfrom legal obligations.BS ISO 10936-2:2010Reference numberISO 10936-2:2010(E)ISO 2010INTERNATIONAL STANDARD ISO10936-2Second edition2010-01-15Optics and photonics Operation microscopes Part 2: Light

5、hazard from operation microscopes used in ocular surgery Optique et photonique Microscopes chirurgicaux Partie 2: Danger de la lumire provenant des microscopes opratoires utiliss en chirurgie oculaire BS ISO 10936-2:2010ISO 10936-2:2010(E) PDF disclaimer This PDF file may contain embedded typefaces.

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10、right office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2010 All rights reservedBS ISO 10936-2:2010ISO 10936-2:2010(E) ISO 2010 All rights reserved iiiForeword ISO (the International Organizat

11、ion for Standardization) is a worldwide 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 h

12、as the right to be represented on that committee. 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. Int

13、ernational Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Public

14、ation as an International Standard requires approval by at least 75 % of the member bodies casting a vote. 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 ri

15、ghts. ISO 10936-2 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 7, Ophthalmic optics and instruments. This second edition cancels and replaces the first edition (ISO 10936-2:2001) which has been technically revised. ISO 10936 consists of the following parts, u

16、nder the general title Optics and photonics Operation microscopes: Part 1: Requirements and test methods Part 2: Light hazard from operation microscopes used in ocular surgery BS ISO 10936-2:2010BS ISO 10936-2:2010INTERNATIONAL STANDARD ISO 10936-2:2010(E) ISO 2010 All rights reserved 1Optics and ph

17、otonics Operation microscopes Part 2: Light hazard from operation microscopes used in ocular surgery 1 Scope This part of ISO 10936 specifies requirements and test methods for optical radiation hazards from operation microscopes that are used during ocular surgery. NOTE General requirements for oper

18、ation microscopes and test methods for these requirements are specified in ISO 10936-1. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition o

19、f the referenced document (including any amendments) applies. ISO 10936-1, Optics and optical instruments Operation microscopes Part 1: Requirements and test methods ISO 15004-2:2007, Ophthalmic instruments Fundamental requirements and test methods Part 2: Light hazard protection 3 Terms and definit

20、ions For the purposes of this document, the following terms and definitions apply. 3.1 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 15004-2:2007. 3.2 Group 2 instrum

21、ent 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. BS ISO 10936-2:2010ISO 10936-2:2010(E) 2 ISO 2010 All rights reserved4 Requirements for optical radiation hazard 4.1 General Oper

22、ation microscopes shall comply with the light hazard protection requirements given in ISO 15004-2. 4.2 Determination of classification group The operation microscopes shall be classified as Group 1 or Group 2 instruments as defined in ISO 15004-2:2007, Clause 4. The test methods given in Clause 5 of

23、 this part of ISO 10936 shall be used to make this determination. 4.3 Requirements for Group 1 instruments 4.3.1 General The operation microscope shall comply with the requirements of ISO 15004-2:2007, 5.2. 4.3.2 Emission limits The operation microscope shall comply with the requirements of: ISO 150

24、04-2:2007, 5.4.1; and, if applicable, ISO 15004-2:2007, 5.4.2; and, if applicable, ISO 15004-2:2007, 5.4.3. Compliance shall be verified using the test methods given in Clause 5 of this part of ISO 10936. If the status is determined to be Group 1, there are no further requirements. 4.4 Requirements

25、for Group 2 instruments 4.4.1 General If the status is determined to be Group 2, the operation microscope shall comply with the requirements of ISO 15004-2:2007, 5.3. Compliance with ISO 15004-2:2007, 5.3, shall be verified using test methods given in Clause 5 of this part of ISO 10936. 4.4.2 Emissi

26、on limits and guideline values The operation microscope shall comply with the requirements of: ISO 15004-2:2007, 5.5.1; and, if applicable, ISO 15004-2:2007, 5.5.2; and, if applicable, ISO 15004-2:2007, 5.5.3.1; and, if applicable, ISO 15004-2:2007, 5.5.3.2. BS ISO 10936-2:2010ISO 10936-2:2010(E) IS

27、O 2010 All rights reserved 34.4.3 Retinal protection device If the time to reach the aphakic weighted retinal radiant maximum exposure guideline is 30 min at maximum output, a retinal protection device shall be installed in the coaxial light path and for each auxiliary illuminator in the instrument.

28、 When activated, this device shall increase the time to reach the maximum exposure guideline either by a factor of no less than 5 or to a time W 30 min. The status of the protection device, whether activated or unactivated, shall be clearly evident to the user during surgery. 4.4.4 Stability of Iigh

29、t intensity The operation microscope shall be designed to ensure that, when operated at maximum output, differences in output due to ageing, maintenance, servicing, and lamp and component replacements cannot reduce the time and/or number of pulses needed to reach the maximum exposure guideline below

30、 the level determined in accordance with ISO 15004-2:2007, 6.5. This shall be applicable throughout the lifetime of the device when maintained in accordance with the manufacturers specifications. Among other methods, this may be achieved by a risk management process. 5 Test methods See ISO 15004-2:2

31、007, 5.3. For Group 1 instruments, ISO 15004-2:2007, 6.1, 6.2 and 6.4, using appropriate measurement methods as specified in ISO 15004-2:2007, Annex D and Annex E. For Group 2 instruments, ISO 15004-2:2007, 6.3 and 6.4, using appropriate measurement methods as specified in ISO 15004-2:2007, Annex D

32、and Annex E. ISO 15004-2:2007, 6.5.1. ISO 15004-2:2007, 6.5.2 (if applicable). 6 Additional information to be supplied by the manufacturer of Group 2 instruments 6.1 For continuous wave light sources that can be varied in intensity, the time needed to reach the maximum exposure guideline in accordan

33、ce with ISO 15004-2:2007, 6.5.1, for the maximum setting and 50 % of the maximum setting, with and without the retinal protection device, shall be indicated in the users manual (see ISO 15004-2:2007, Clause 7). This information shall also be clearly evident to the user during surgery (see ISO 15004-

34、2:2007, Clause 7). An example of how this information may be provided is given in Annex A. 6.2 Where applicable, for pulsed light sources that can be varied in intensity, the number of pulses needed to reach the maximum exposure guideline in accordance with ISO 15004-2:2007, 6.5.2, for the maximum s

35、etting and 50 % of the maximum setting, with and without the retinal protection device, shall be indicated in the users manual (see ISO 15004-2:2007, Clause 7). 7 Marking For the marking of operation microscopes, see ISO 10936-1. BS ISO 10936-2:2010ISO 10936-2:2010(E) 4 ISO 2010 All rights reservedA

36、nnex A (informative) Example of information regarding maximum retinal exposure guidelines to be provided to the user during surgery Table A.1 Maximum exposure guidelines Maximum output min 50 % maximum output min Without retinal protection device X Y With retinal protection device Z W NOTE This info

37、rmation can be provided in the form of meaningful symbols.The light emitted from this instrument is potentially hazardous. NOTE 1 Exposure times are for cumulative retinal exposure. NOTE 2 Lower intensities increase the maximum exposure times in direct proportion to the decrease in intensities. NOTE

38、 3 Exposure times are given for clear media. Cloudy media and/or blood will increase these times. BS ISO 10936-2:2010BS ISO 10936-2:2010ISO 10936-2:2010(E) ICS 11.040.30; 37.020 Price based on 4 pages ISO 2010 All rights reserved BS ISO 10936-2:2010This page has been intentionally left blank BS ISO1

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