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BS EN ISO 15004:1998

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
Available format(s)

Hardcopy , PDF

Superseded date

06-29-2007

Language(s)

English

Published date

04-15-1998

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
CH/172/6
DevelopmentNote
Supersedes 95/563412 DC (08/2004)
DocumentType
Standard
Pages
24
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

ISO 12867:2010 Ophthalmic instruments Trial frames
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
ISO 10938:2016 Ophthalmic optics Chart displays for visual acuity measurement Printed, projected and electronic
ISO 10943:2011 Ophthalmic instruments — Indirect ophthalmoscopes
ISO 10944:2009 Ophthalmic instruments — Synoptophores
ISO 9801:2009 Ophthalmic instruments — Trial case lenses
ISO 10942:2006 Ophthalmic instruments Direct ophthalmoscopes
ISO 10341:2012 Ophthalmic instruments — Refractor heads
ISO 10343:2014 Ophthalmic instruments — Ophthalmometers
ISO 10342:2010 Ophthalmic instruments Eye refractometers
ISO 10940:2009 Ophthalmic instruments — Fundus cameras
ISO 12866:1999 Ophthalmic instruments Perimeters
IEC 60601-1-1:2000 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
ISO 10939:2017 Ophthalmic instruments — Slit-lamp microscopes
ISO 12865:2006 Ophthalmic instruments Retinoscopes

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