ISO INTERNATIONAL STANDARD 10936-2 Second edition 2010-01-15 Optics and photonics Operation microscopes Part 2: Light hazard from operation microscopes used in ocular surgery Optiqueetphotonique-Microscopeschirurgicaux Partie2:Danger de la lumiere provenant des microscopes operatoires utilisés enchirurgieoculaire Reference number ISO 10936-2:2010(E) @ISO2010 Copyright Intemational Organization for Standardization Not for Resale ISO 10936-2:2010(E) Foreword IsO (the International Organization for Standardization) is a worldwide federation of national standards bodies 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. International Standardsaredrafted inaccordance withthe rulesgiveninthe ISO/lEC Directives,Part2 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. Publication 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 rights. ISO10936-2 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 7, Ophthalmicopticsandinstruments. 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, under the general title Optics and photonics- ( Operation microscopes: Part1:Requirementsandtestmethods Part2:Light hazardfromoperationmicroscopes used in ocular surgery ili arda Not fr Resale INTERNATIONALSTANDARD ISO10936-2:2010(E) Optics and photonics Operation microscopes Part 2: Light hazard from operation microscopes used in ocular surgery 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 operation 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 of the referenced document (including any amendments) applies. Iso 10936-1,Optics and optical instruments-Operation microscopes-Part 1:Requirements and test methods Iso15004-2:2007,Ophthalmic instruments—Fundamental requirements and testmethods-Part2:Light hazard protection 3Terms and definitions 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 IS15004-2:2007,5.2 NOTE Adapted from ISO 15004-2:2007. 3.2 Group2instrument 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. Copyrahtintemational onganizaionfor Standardzallon'ghts reserved ISO10936-2:2010(E) 4Requirementsforoptical radiationhazard 4.1 General Operation microscopes shall comply with the light hazard protection requirements given in IsO 15004-2. 4.2Determination of classificationgroup TheoperationmicroscopesshallbeclassifiedasGroup1 orGroup2instruments asdefined in ISO 15004-2:2007, Clause 4.The test methods given in Clause5 of this part of ISO10936 shall be used to make this determination. 4.3RequirementsforGroup1instruments 4.3.1 General 4.3.2Emission limits The operation microscope shall comply with the requirements of: ISO 15004-2:2007, 5.4.1; and, if applicable, IsO 15004-2:2007, 5.4.2; and, if applicable, Is0 15004-2:2007, 5.