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AFNOR
NF EN ISO 15004-1 : 2009

NF EN ISO 15004-1 : 2009

Withdrawn

Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

View Superseded by

OPHTHALMIC INSTRUMENTS - FUNDAMENTAL REQUIREMENTS AND TEST METHODS - PART 1: GENERAL REQUIREMENTS APPLICABLE TO ALL OPHTHALMIC INSTRUMENTS

Withdrawn date

09-11-2021

Superseded by

NF EN ISO 15004-1:2020

Published date

12-01-2013

Publisher

Association Francaise de Normalisation

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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)
DocumentType
Standard
PublisherName
Association Francaise de Normalisation
Status
Withdrawn
SupersededBy

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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