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OPHTHALMIC INSTRUMENTS - FUNDAMENTAL REQUIREMENTS AND TEST METHODS - PART 1: GENERAL REQUIREMENTS APPLICABLE TO ALL OPHTHALMIC INSTRUMENTS
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Withdrawn date: 09-11-2021
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Published date: 12-01-2013
Publisher: Association Francaise de Normalisation
Avant-propos1 Domaine d'application2 Références normatives3 Termes et définitions4 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 mécaniques5 Conditions environnementales (pour instruments ophtalmiques non actifs et actifs) 5.1 Conditions environnementales d'utilisation 5.2 Conditions de stockage 5.3 Conditions de transport6 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 optique7 Méthodes d'essai 7.1 Inflammabilité 7.2 Températures de surface 7.3 Conditions environnementales 7.4 Controle de la sécurité électrique8 Informations fournies par le fabricant 8.1 Documents d'accompagnement 8.2 MarquageAnnexe 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.
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