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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Ophthalmic instruments. Fundamental requirements and test methods General requirements applicable to all ophthalmic instruments
Hardcopy , PDF
30-11-2020
English
31-07-2009
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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.
| Committee |
CH/172/6
|
| DevelopmentNote |
Supersedes 04/30103854 DC. (06/2006) Together with BS EN ISO 15004-2, it supersedes BS EN ISO 15004. (06/2007)
|
| DocumentType |
Standard
|
| Pages |
18
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ONORM EN ISO 15004-1 : 2009 | Identical |
| 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 |
| I.S. 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 |
| 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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