NF EN ISO 15004-1

NF EN ISO 15004-1

August 2009
Standard Cancelled

Ophthalmic instruments - Fundamental requirements and test methods - Part 1 : general requirements applicable to all ophthalmic instruments

ISO 15004-1:2006 specifies fundamental requirements for non-invasive, active and non-active ophthalmic instruments. ISO 15004-1:2006 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. ISO 15004-1:2006 is not applicable to operation microscopes, endoscopes and devices intended for laser investigation or laser treatment of the eye.

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Main informations

Collections

National standards and national normative documents

Publication date

August 2009

Number of pages

16 p.

Reference

NF EN ISO 15004-1

ICS Codes

11.040.70   Ophthalmic equipment

Classification index

S12-300-1

Print number

1 - 03/08/2009

International kinship

ISO 15004-1:2006

European kinship

EN ISO 15004-1:2009
Sumary
Ophthalmic instruments - Fundamental requirements and test methods - Part 1 : general requirements applicable to all ophthalmic instruments

ISO 15004-1:2006 specifies fundamental requirements for non-invasive, active and non-active ophthalmic instruments. ISO 15004-1:2006 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.

ISO 15004-1:2006 is not applicable to operation microscopes, endoscopes and devices intended for laser investigation or laser treatment of the eye.

Replaced standards (1)
NF EN ISO 15004-1
August 2007
Standard Cancelled
Ophthalmic instruments - Fundamental requirements and test methods - Part 1 : general requirements applicable to all ophthalmic instruments

Le présent document spécifie les exigences fondamentales s'appliquant aux instruments ophtalmiques non invasifs, actifs et non actifs. Il est également applicable aux instruments d'aide visuelle destinés aux visions déficientes ainsi qu'aux tonomètres, mais ne s'applique pas aux autres instruments ophtalmiques utilisés au contact du globe oculaire.

Standard replaced by (1)
NF EN ISO 15004-1
November 2020
Standard Current
Ophthalmic instruments - Fundamental requirements and test methods - Part 1 : general requirements applicable to all ophthalmic instruments

<p>This document specifies fundamental requirements for non-invasive, active and non-active ophthalmic instruments and to devices for enhancing low vision. This document is also applicable to tonometers, but not to other ophthalmic instruments which are used in contact with the globe of the eye.</p> <p>This document is not applicable to operation microscopes, endoscopes and devices intended for laser investigation or laser treatment of the eye.</p>

Table of contents
View the extract
  • Avant-propos
    iv
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    2
  • 4 Exigences fondamentales (pour instruments ophtalmiques non actifs et actifs)
    2
  • 4.1 Généralités
    2
  • 4.2 Conception
    2
  • 4.3 Performance
    2
  • 4.4 Combinaison de dispositifs différents
    2
  • 4.5 Matériaux
    3
  • 4.6 Protection contre les contaminants
    3
  • 4.7 Graduations et affichage
    3
  • 4.8 Risques thermiques
    3
  • 4.9 Risques mécaniques
    3
  • 5 Conditions environnementales (pour instruments ophtalmiques non actifs et actifs)
    3
  • 5.1 Conditions environnementales d'utilisation
    3
  • 5.2 Conditions de stockage
    4
  • 5.3 Conditions de transport
    4
  • 6 Exigences particulières relatives aux instruments ophtalmiques actifs
    5
  • 6.1 Sécurité électrique
    5
  • 6.2 Articles non applicables de la IEC 60601-1:2005
    5
  • 6.3 Risques liés au rayonnement optique
    5
  • 7 Méthodes d'essai
    5
  • 7.1 Inflammabilité
    5
  • 7.2 Températures de surface
    5
  • 7.3 Conditions environnementales
    5
  • 7.4 Contrôle de la sécurité électrique
    7
  • 8 Informations fournies par le fabricant
    7
  • 8.1 Documents d'accompagnement
    7
  • 8.2 Marquage
    7
  • Annexe A (informative) Normes internationales de produits relatives aux instruments ophtalmiques
    8
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