I.S. 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
OPHTHALMIC INSTRUMENTS - FUNDAMENTAL REQUIREMENTS AND TEST METHODS - PART 1: GENERAL REQUIREMENTS APPLICABLE TO ALL OPHTHALMIC INSTRUMENTS
Hardcopy , PDF
04-01-2021
English
01-01-2009
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.
Dates of withdrawal of national standards are available from NSAI.
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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Superseded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 |
| Standards | Relationship |
| UNE-EN ISO 15004-1:2009 | Identical |
| UNI EN ISO 15004-1 : 2009 | Identical |
| SN EN ISO 15004-1 : 2009 | Identical |
| NBN EN ISO 15004-1 : 2009 | Identical |
| NS EN ISO 15004-1 : 2009 | Identical |
| BS EN ISO 15004-1:2009 | Identical |
| DIN EN ISO 15004-1:2009-07 | Identical |
| EN ISO 15004-1:2009 | Identical |
| ISO 15004-1:2006 | Identical |
| NF EN ISO 15004-1 : 2009 | Identical |
| NEN EN ISO 15004-1 : 2009 | Identical |
| ONORM EN ISO 15004-1 : 2009 | Identical |
| 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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