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EN ISO 15004 : 1997

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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

Superseded date

06-01-2006

Published date

01-12-2013

1 Scope
2 Normative references
3 Definitions
4 Fundamental requirements (for non-active and active
    ophthalmic instruments)
5 Environmental conditions (for non-active and active
    ophthalmic instruments)
6 Particular requirements for active ophthalmic instruments
7 Test methods
8 Information supplied by the manufacturer
Annex A (normative) Optical radiation hazard
Annex B (normative) Product-related International Standards
for ophthalmic instruments
Annex C (informative) Photometric quantities
Annex D (informative) Example of information on the avoidance of
overexposure to potentially hazardous optical radiation

Defines 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 for use in contact with the globe of the eye.

Committee
TC 170
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Superseded
SupersededBy

EN ISO 15253:2000 OPHTHALMIC OPTICS AND INSTRUMENTS - OPTICAL DEVICES FOR ENHANCING LOW VISION
DIN EN ISO 12866:2009-03 OPHTHALMIC INSTRUMENTS - PERIMETERS
ISO 15253:2000 Ophthalmic optics and instruments Optical devices for enhancing low vision
BS EN ISO 15253:2000 Ophthalmic optics and instruments. Optical devices for low-vision aids

ISO 9022-3:2015 Optics and photonics Environmental test methods Part 3: Mechanical stress
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
ISO 9022-2:2015 Optics and photonics Environmental test methods Part 2: Cold, heat and humidity
IEC 60601-1-1:2000 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems

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