NF EN ISO 15004-2

NF EN ISO 15004-2

May 2007
Standard Current

Ophthalmic instruments - Fundamental requirements and test methods - Part 2 : light hazard protection

ISO 15004-2:2007 specifies fundamental requirements for optical radiation safety for ophthalmic instruments and is applicable to all ophthalmic instruments that direct optical radiation into or at the eye and for which there is a specific light hazards requirement section within their respective International Standards. It is also applicable to all new and emerging ophthalmic instruments that direct optical radiation into or at the eye. ISO 15004-2:2007 does not apply to radiation that is in excess of limits specified in ISO 15004 and that is intended for treatment of the eye. ISO 15004-2:2007 classifies ophthalmic instruments into either Group 1 or a Group 2 in order to distinguish instruments that are non-hazardous from those that are potentially hazardous.

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Main informations

Collections

National standards and national normative documents

Publication date

May 2007

Number of pages

47 p.

Reference

NF EN ISO 15004-2

ICS Codes

11.040.70   Ophthalmic equipment

Classification index

S12-300-2

Print number

1 - 18/04/2007

International kinship

ISO 15004-2:2007

European kinship

EN ISO 15004-2:2007
Sumary
Ophthalmic instruments - Fundamental requirements and test methods - Part 2 : light hazard protection

ISO 15004-2:2007 specifies fundamental requirements for optical radiation safety for ophthalmic instruments and is applicable to all ophthalmic instruments that direct optical radiation into or at the eye and for which there is a specific light hazards requirement section within their respective International Standards. It is also applicable to all new and emerging ophthalmic instruments that direct optical radiation into or at the eye.

ISO 15004-2:2007 does not apply to radiation that is in excess of limits specified in ISO 15004 and that is intended for treatment of the eye.

ISO 15004-2:2007 classifies ophthalmic instruments into either Group 1 or a Group 2 in order to distinguish instruments that are non-hazardous from those that are potentially hazardous.

Replaced standards (1)
NF EN ISO 15004
March 1998
Standard Cancelled
Ophthalmic instruments. Fundamental requirements and test methods.

Table of contents
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  • Avant-propos
    iv
  • 1
    Domaine d'application 1
  • 2
    Références normatives 1
  • 3
    Termes, définitions et symboles 1
  • 3.1
    Termes et définitions 1
  • 3.2
    Symboles 5
  • 4 Classification
    6
  • 5
    Exigences 6
  • 5.1
    Généralités 6
  • 5.2
    Exigences de classification en tant qu'instrument du Groupe 1 6
  • 5.3
    Exigences liées aux instruments du Groupe 2 7
  • 5.4
    Limites d'émission pour la détermination de la classification du Groupe 1 7
  • 5.5
    Limites d'émission et recommandations pour les instruments du Groupe 2 12
  • 6
    Méthodes d'essai 19
  • 6.1
    Généralités 19
  • 6.2
    Mesurages effectués pour classer les instruments dans les Groupe 1 ou 2 19
  • 6.3
    Instruments du Groupe 2: Mesurages 19
  • 6.4
    Détermination de la surface 20
  • 6.5
    Instruments du Groupe 2: Détermination de la durée et du nombre d'impulsions pour atteindre l'exposition maximale conseillée 20
  • 7 Informations fournies par le fabricant
    21
  • Annexe A (normative) Fonctions de pondération spectrale
    23
  • Annexe B (informative) Normes internationales de produits relatives aux instruments ophtalmiques, y compris l'ISO 15004-2, contenant une section relative aux dangers liés au rayonnement
    29
  • Annexe C (informative) Instruments de mesure
    30
  • Annexe D (normative) Méthodes de mesure de la luminance énergétique/ de l'éclairement énergétique
    31
  • Annexe E (informative) Lignes directrices pour le mesurage direct de l'éclairement énergétique
    37
  • Annexe F (informative) Logigramme de classification
    39
  • Bibliographie
    41
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