19/30351471 DC - BS EN ISO 15004-1. Ophthalmic instruments. Fundamental requirements and test methods. Part 1. General requirements applicable to all ophthalmic instruments

19/30351471 DC

BS EN ISO 15004-1. Ophthalmic instruments. Fundamental requirements and test methods. Part 1. General requirements applicable to all ophthalmic instruments

Status : Current, Draft for public comment   Published : June 2019

Format
PDF

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HARDCOPY



This document specifies fundamental requirements for non-invasive, active and non-active ophthalmic instruments and to low-vision aids. 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.




Standard Number19/30351471 DC
TitleBS EN ISO 15004-1. Ophthalmic instruments. Fundamental requirements and test methods. Part 1. General requirements applicable to all ophthalmic instruments
StatusCurrent, Draft for public comment
Publication Date11 June 2019
Normative References(Required to achieve compliance to this standard)ISO 15004-2:2007, IEC 60601-1:2005/AMD1:2012, IEC 60695-2-11, IEC 60695-2-10
Informative References(Provided for Information)ISO 10993-1, ISO 14971, ISO 13485:2016
International RelationshipsISO/DIS 15004-1
Draft Expiry Date31 July 2019
DescriptorsOphthalmic equipment, Ophthalmology, Instructions for use, Electrical safety, Clinical investigation instruments, Medical equipment, Hazards, Transportation, Environment (working), Environmental testing, Storage
ICS11.040.70
Title in FrenchInstruments ophtalmiques — Exigences fondamentales et méthodes d'essai — Partie 1: Exigences générales applicables à tous les instruments ophtalmiques Partie 1: Exigences générales applicables à tous les instruments ophtalmiques
CommitteeCH/172
PublisherBSI
FormatA4
DeliveryYes
Pages15
File Size302 KB
NotesWarning: this draft is not current beyond its expiry date for comments.
Price£20.00


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