NEN EN ISO 15004-1 : 2009
Current
The latest, up-to-date edition.
OPHTHALMIC INSTRUMENTS - FUNDAMENTAL REQUIREMENTS AND TEST METHODS - PART 1: GENERAL REQUIREMENTS APPLICABLE TO ALL OPHTHALMIC INSTRUMENTS
12-01-2013
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 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 hazards
5 Environmental conditions (for non-active and active
ophthalmic instruments)
5.1 Environmental conditions of use
5.2 Storage conditions
5.3 Transport conditions
6 Particular requirements for active ophthalmic instruments
6.1 Electrical safety
6.2 Inapplicable clauses of IEC 60601-1:2005
6.3 Optical radiation hazard
7 Test methods
7.1 Ignitability
7.2 Surface temperatures
7.3 Environmental conditions
7.4 Checking electrical safety
8 Information supplied by the manufacturer
8.1 Accompanying documents
8.2 Marking
Annex A (informative) Product-related International Standards
for ophthalmic instruments
Annex ZA (informative) Relationship between this European Standard
and the Essential Requirements of EU
Directive 93/42/EEC on medical devices
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