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OPHTHALMIC INSTRUMENTS - FUNDAMENTAL REQUIREMENTS AND TEST METHODS - PART 1: GENERAL REQUIREMENTS APPLICABLE TO ALL OPHTHALMIC INSTRUMENTS
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Available format(s): Hardcopy, PDF
Superseded date: 04-01-2021
Language(s): English
Published date: 01-01-2009
Publisher: National Standards Authority of Ireland
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.Only cited Standards give presumption of conformance to New Approach Directives/Regulations.Dates of withdrawal of national standards are available from NSAI.
Foreword1 Scope2 Normative references3 Terms and definitions4 Fundamental requirements (for non-active and active ophthalmic instruments) 4.1 General 4.2 Design 4.3 Performance 4.4 Combination of different devices 4.5 Materials 4.6 Protection against contaminants 4.7 Scales and displays 4.8 Thermal hazards 4.9 Mechanical hazards5 Environmental conditions (for non-active and active ophthalmic instruments) 5.1 Environmental conditions of use 5.2 Storage conditions 5.3 Transport conditions6 Particular requirements for active ophthalmic instruments 6.1 Electrical safety 6.2 Inapplicable clauses of IEC 60601-1:2005 6.3 Optical radiation hazard7 Test methods 7.1 Ignitability 7.2 Surface temperatures 7.3 Environmental conditions 7.4 Checking electrical safety8 Information supplied by the manufacturer 8.1 Accompanying documents 8.2 MarkingAnnex A (informative) - Product-related International Standards for ophthalmic instrumentsAnnex ZA (informative) - Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC
Describes fundamental requirements for non-invasive, active and non-active ophthalmic instruments. Also applicable to low-vision aids and tonometers, but not to other ophthalmic instruments which are used in contact with the globe of the eye.
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