BS EN ISO 15004-1:2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Ophthalmic instruments. Fundamental requirements and test methods General requirements applicable to all ophthalmic instruments
Hardcopy , PDF
11-30-2020
English
07-31-2009
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
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