ISO/FDIS 15004-2

Ophthalmic instruments — Fundamental requirements and test methods — Part 2: Light hazard protection

Instruments ophtalmiques — Exigences fondamentales et méthodes d'essai — Partie 2: Protection contre les dangers de la lumière

General Information

• Status: Withdrawn
• ICS: 11.040.70 - Ophthalmic equipment
• Technical Committee: ISO/TC 172/SC 7 - Ophthalmic optics and instruments
• Drafting Committee: ISO/TC 172/SC 7/WG 6 - Ophthalmic instruments and test methods
• Current Stage: 5098 - Project deleted
• Completion Date: 08-Feb-2016

Relations

• Revises: ISO 15004-2:2007 - Ophthalmic instruments — Fundamental requirements and test methods — Part 2: Light hazard protection
• Effective Date: 15-Oct-2011

Standards Content (Sample)

© ISO 2015 – All rights reserved
ISO/TC 172/SC 7
Date: 2015‐05‐14
ISO/FDIS 15004-2:2015(E)
ISO/TC 172/SC 7/WG 6
Secretariat: DIN
Ophthalmic instruments — Fundamental requirements and test methods —
Part 2: Light hazard protection
Instruments ophtalmiques — Exigences fondamentales et méthodes d'essai — Partie 2: Protection contre les dangers
de la lumière
Document type:  International Standard
Document subtype:
Document stage:  (50) Approval
Document language:  E

D:\ISO\isomacroserver-
prod\temp\DOC2PDFRGB2010\DOC2PDFRGB2010.mathew@LMATHEW_181\C060552e_trackchanges.doc
 STD Version 2.5a

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ISO/FDIS 15004-2:2015(E)
Copyright notice
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ii © ISO 2015 – All rights reserved

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ISO/FDIS 15004-2:2015(E)
Contents Page


© ISO 2015 – All rights reserved iii

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ISO/FDIS 15004-2:2015(E)
Foreword
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(see www.iso.org/directives.).
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Publication as an International Standard requires approval by at least 75 % of the member bodies
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Attention is drawn to the possibility that some of the elements of this document may be the subject of
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For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO's adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword ‐ Supplementary informationISO 15004‐2
was prepared by Technical Committee
The committee responsible for this document is ISO/TC 172, Optics and photonics, Subcommittee SC 7,
Ophthalmic optics and instruments.
This second edition cancels and replaces the first edition (EN ISO 15004‐2:2007), which has been
technically revised.
ISO 15004 consists of the following parts, under the general title Ophthalmic instruments —
Fundamental requirements and test methods:
— Part 1: General requirements applicable to all ophthalmic instruments
— Part 2: Light hazard protection

iv © ISO 2015 – All rights reserved

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FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 15004-2:2015(E)

Ophthalmic instruments — Fundamental requirements and test
methods — Part 2: Light hazard protection
1 Scope
This part of ISO 15004 specifies fundamental requirements for optical radiation safety for ophthalmic
instruments and. It is applicable to all ophthalmic instruments that direct optical radiation into o
...

FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 15004-2
ISO/TC 172/SC 7
Ophthalmic instruments —
Secretariat: DIN
Fundamental requirements and test
Voting begins on:
2015-09-24 methods —
Voting terminates on:
Part 2:
2015-11-24
Light hazard protection
Instruments ophtalmiques — Exigences fondamentales et
méthodes d’essai —
Partie 2: Protection contre les dangers de la lumière
Please see the administrative notes on page iii
RECIPIENTS OF THIS DRAFT ARE INVITED TO
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/FDIS 15004-2:2015(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
©
NATIONAL REGULATIONS. ISO 2015

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ISO/FDIS 15004-2:2015(E)

ISO/CEN PARALLEL PROCESSING
This final draft has been developed within the International Organization for Standardization (ISO), and pro-
cessed under the ISO-lead mode of collaboration as defined in the Vienna Agreement. The final draft was
established on the basis of comments received during a parallel enquiry on the draft.
This final draft is hereby submitted to the ISO member bodies and to the CEN member bodies for a parallel
two-month approval vote in ISO and formal vote in CEN.
Positive votes shall not be accompanied by comments.
Negative votes shall be accompanied by the relevant technical reasons.
COPYRIGHT PROTECTED DOCUMENT
© ISO 2015, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. [phone]
Fax [phone]
[e-mail]
www.iso.org
ii © ISO 2015 – All rights reserved

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ISO/FDIS 15004-2:2015(E)

Contents Page
Foreword .v
1 Scope . 1
2 Normative references . 1
3 Terms, definitions and symbols . 1
3.1 Terms and definitions . 1
3.2 Symbols . 4
4 Classification . 6
5 Requirements . 6
5.1 General . 6
5.2 Requirements for classification as a Group 1 instrument . 6
5.2.1 General. 6
5.2.2 Requirements for classification as Group 1 for a scanning instrument . 7
5.3 Requirements for Group 2 instruments . 7
5.4 Emi
...

PROJET
NORME ISO/FDIS
FINAL
INTERNATIONALE 15004-2
ISO/TC 172/SC 7
Instruments ophtalmiques —
Secrétariat: DIN
Exigences fondamentales et
Début de vote:
2015-09-24 méthodes d’essai —
Vote clos le:
Partie 2:
2015-11-24
Protection contre les dangers de la
lumière
Ophthalmic instruments — Fundamental requirements and test
methods —
Part 2: Light hazard protection
LES DESTINATAIRES DU PRÉSENT PROJET SONT
INVITÉS À PRÉSENTER, AVEC LEURS OBSER-
Veuillez consulter les notes administratives en page iii
VATIONS, NOTIFICATION DES DROITS DE PRO-
PRIÉTÉ DONT ILS AURAIENT ÉVENTUELLEMENT
CONNAISSANCE ET À FOURNIR UNE DOCUMEN-
TATION EXPLICATIVE.
OUTRE LE FAIT D’ÊTRE EXAMINÉS POUR
ÉTABLIR S’ILS SONT ACCEPTABLES À DES FINS
INDUSTRIELLES, TECHNOLOGIQUES ET COM-
Numéro de référence
MERCIALES, AINSI QUE DU POINT DE VUE
ISO/FDIS 15004-2:2015(F)
DES UTILISATEURS, LES PROJETS DE NORMES
INTERNATIONALES DOIVENT PARFOIS ÊTRE
CONSIDÉRÉS DU POINT DE VUE DE LEUR POSSI-
BILITÉ DE DEVENIR DES NORMES POUVANT
SERVIR DE RÉFÉRENCE DANS LA RÉGLEMENTA-
©
TION NATIONALE. ISO 2015

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ISO/FDIS 15004-2:2015(F)

TRAITEMENT PARALLÈLE ISO/CEN
Le présent projet final a été élaboré dans le cadre de l’Organisation internationale de normalisation (ISO) et
soumis selon le mode de collaboration sous la direction de l’ISO, tel que défini dans l’Accord de Vienne. Le
projet final a été établi sur la base des observations reçues lors de l’enquête parallèle sur le projet.
Le projet final est par conséquent soumis aux comités membres de l’ISO et aux comités membres du CEN en
parallèle à un vote d’approbation de deux mois au sein de l’ISO et à un vote formel au sein du CEN.
Les votes positifs ne doivent pas être accompagnés d’observations.
Les votes négatifs doivent être accompagnés des arguments techniques pertinents.
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2015, Publié en Suisse
Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite ni utilisée
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l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. [phone]
Fax [phone]
[e-mail]
www.iso.org
ii © ISO 2015 – Tous droits réservés

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ISO/FDIS 15004-2:2015(F)
Sommaire Page
Avant-propos . 4
1 Domaine d'application . 1
2 Références normatives . 1
3 Termes, définitions et symboles . 2
3.1 Termes et définitions . 2
3.2 Symboles . 5
4 Classification . 7
5 Exigences . 7
5.1 Généralités . 7
5.2 Exigences de classification en tant qu'instrument du Groupe 1 . 8
5.3 Exigences liées aux instruments du Groupe 2 . 9
5.4 Limites d'émission pour la détermination de la classification du Groupe 1 . 10
5.5 Valeurs limites d'émission et d'exposition pour les instruments du Groupe 2 . 15
6 Méthodes d'essai . 20
6.1 Généralités . 20
6
...