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I.S. EN ISO 15004-1:2009

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - PART 1: GENERAL REQUIREMENTS APPLICABLE TO ALL OPHTHALMIC INSTRUMENTS
Available format(s)

Hardcopy , PDF

Superseded date

04-01-2021

Language(s)

English

Published date

01-01-2009

Preview

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.

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

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.

DevelopmentNote
Supersedes I.S. EN ISO 15004. (08/2006)
DocumentType
Standard
Pages
22
PublisherName
National Standards Authority of Ireland
Status
Superseded
SupersededBy
Supersedes

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 60695-2-11:2014 Fire hazard testing - Part 2-11: Glowing/hot-wire based test methods - Glow-wire flammability test method for end-products (GWEPT)
ISO 15004-2:2007 Ophthalmic instruments Fundamental requirements and test methods Part 2: Light hazard protection
IEC 60695-2-10:2013 Fire hazard testing - Part 2-10: Glowing/hot-wire based test methods - Glow-wire apparatus and common test procedure
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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$66.40
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