NF EN ISO 15004-1

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

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. This document 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

November 2020

Number of pages

14 p.

Reference

NF EN ISO 15004-1

ICS Codes

11.040.70   Ophthalmic equipment

Classification index

S12-300-1

Print number

1

International kinship

ISO 15004-1:2020

European kinship

EN ISO 15004-1:2020
Sumary
Ophthalmic instruments - Fundamental requirements and test methods - Part 1 : general requirements applicable to all ophthalmic instruments

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.

This document 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 2009
Standard Cancelled
Ophthalmic instruments - Fundamental requirements and test methods - Part 1 : general requirements applicable to all ophthalmic instruments

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

Table of contents
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  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Exigences fondamentales
  • 5 Conditions environnementales
  • 6 Exigences particulières relatives aux instruments ophtalmiques actifs
  • 7 Méthodes d'essai
  • 8 Informations fournies par le fabricant
  • Annexe A Normes internationales de produits relativesaux instruments ophtalmiques
  • Bibliographie
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