NF EN ISO 15004-1 : 2009
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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OPHTHALMIC INSTRUMENTS - FUNDAMENTAL REQUIREMENTS AND TEST METHODS - PART 1: GENERAL REQUIREMENTS APPLICABLE TO ALL OPHTHALMIC INSTRUMENTS
09-11-2021
12-01-2013
Avant-propos
1 Domaine d'application
2 Références normatives
3 Termes et définitions
4 Exigences fondamentales (pour instruments ophtalmiques
non actifs et actifs)
4.1 Généralités
4.2 Conception
4.3 Performance
4.4 Combinaison de dispositifs différents
4.5 Matériaux
4.6 Protection contre les contaminants
4.7 Graduations et affichage
4.8 Risques thermiques
4.9 Risques mécaniques
5 Conditions environnementales (pour instruments
ophtalmiques non actifs et actifs)
5.1 Conditions environnementales d'utilisation
5.2 Conditions de stockage
5.3 Conditions de transport
6 Exigences particulières relatives aux instruments
ophtalmiques actifs
6.1 Sécurité électrique
6.2 Articles non applicables de la CEI 60601-1:2005
6.3 Risques liés au rayonnement optique
7 Méthodes d'essai
7.1 Inflammabilité
7.2 Températures de surface
7.3 Conditions environnementales
7.4 Controle de la sécurité électrique
8 Informations fournies par le fabricant
8.1 Documents d'accompagnement
8.2 Marquage
Annexe A (informative) Normes internationales de produits
relatives aux instruments ophtalmiques
Specifies fundamental requirements for non-invasive, active and non-active ophthalmic instruments. It is 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 |
Indice de classement: S12-300-1. PR NF EN ISO 15004-1 August 2004. (08/2004) Supersedes NF EN ISO 15004. (10/2007) PR NF EN ISO 15004-1 January 2009. (01/2009)
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| DocumentType |
Standard
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| PublisherName |
Association Francaise de Normalisation
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| Status |
Withdrawn
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| SupersededBy |
| 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 |
| ONORM EN ISO 15004-1 : 2009 | Identical |
| NS EN ISO 15004-1 : 2009 | Identical |
| BS 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 |
| NEN EN ISO 15004-1 : 2009 | Identical |
| NF EN 14753 : 2008 | SAFETY OF MACHINERY - SAFETY REQUIREMENTS FOR MACHINERY AND EQUIPMENT FOR THE CONTINUOUS CASTING OF STEEL |
| NF EN ISO 10942 : 2007 | OPHTHALMIC INSTRUMENTS - DIRECT OPHTHALMOSCOPES |
| NF EN 15061 : 2007 + A1 2009 | SAFETY OF MACHINERY - SAFETY REQUIREMENTS FOR STRIP PROCESSING LINE MACHINERY AND EQUIPMENT |
| 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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