Optics and photonics — Operation microscopes — Part 2: Light hazard from operation microscopes used in ocular surgery

ISO 10936-2:2010 specifies requirements and test methods for optical radiation hazards from operation microscopes that are used during ophthalmic surgery.

Optique et photonique — Microscopes chirurgicaux — Partie 2: Danger de la lumière provenant des microscopes opératoires utilisés en chirurgie oculaire

L'ISO 10936-2:2010 spécifie les exigences et les méthodes d'essai relatives aux dangers du rayonnement lumineux provenant des microscopes opératoires utilisés en chirurgie ophtalmique.

General Information

Status
Published
Publication Date
03-Jan-2010
Current Stage
9093 - International Standard confirmed
Completion Date
10-Sep-2020
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INTERNATIONAL ISO
STANDARD 10936-2
Second edition
2010-01-15

Optics and photonics — Operation
microscopes —
Part 2:
Light hazard from operation microscopes
used in ocular surgery
Optique et photonique — Microscopes chirurgicaux —
Partie 2: Danger de la lumière provenant des microscopes opératoires
utilisés en chirurgie oculaire




Reference number
ISO 10936-2:2010(E)
©
ISO 2010

---------------------- Page: 1 ----------------------
ISO 10936-2:2010(E)
PDF disclaimer
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accepts no liability in this area.
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COPYRIGHT PROTECTED DOCUMENT


©  ISO 2010
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
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Published in Switzerland

ii © ISO 2010 – All rights reserved

---------------------- Page: 2 ----------------------
ISO 10936-2:2010(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 10936-2 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 7,
Ophthalmic optics and instruments.
This second edition cancels and replaces the first edition (ISO 10936-2:2001) which has been technically
revised.
ISO 10936 consists of the following parts, under the general title Optics and photonics — Operation
microscopes:
⎯ Part 1: Requirements and test methods
⎯ Part 2: Light hazard from operation microscopes used in ocular surgery

© ISO 2010 – All rights reserved iii

---------------------- Page: 3 ----------------------
INTERNATIONAL STANDARD ISO 10936-2:2010(E)

Optics and photonics — Operation microscopes —
Part 2:
Light hazard from operation microscopes used in ocular
surgery
1 Scope
This part of ISO 10936 specifies requirements and test methods for optical radiation hazards from operation
microscopes that are used during ocular surgery.
NOTE General requirements for operation microscopes and test methods for these requirements are specified in
ISO 10936-1.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 10936-1, Optics and optical instruments — Operation microscopes — Part 1: Requirements and test
methods
ISO 15004-2:2007, Ophthalmic instruments — Fundamental requirements and test methods — Part 2: Light
hazard protection
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
Group 1 instrument
ophthalmic instrument for which no potential light hazard exists and that can be shown to fulfil the
requirements of ISO 15004-2:2007, 5.2
NOTE Adapted from ISO 15004-2:2007.
3.2
Group 2 instrument
ophthalmic instrument for which a potential light hazard exists and that does not fulfil the requirements of
ISO 15004-2:2007, 5.2
NOTE Adapted from ISO 15004-2:2007.
© ISO 2010 – All rights reserved 1

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...

DRAFT INTERNATIONAL STANDARD ISO/DIS 10936-2
ISO/TC 172/SC 7 Secretariat: DIN
Voting begins on: Voting terminates on:
2008-03-25 2008-08-25
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION • МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ • ORGANISATION INTERNATIONALE DE NORMALISATION
Optics and photonics — Operation microscopes —
Part 2:
Light hazard from operation microscopes used in ocular surgery
Optique et photonique — Microscopes chirurgicaux —
Partie 2: Danger de la lumière provenant des microscopes opératoires utilisés en chirurgie oculaire
[Revision of first edition (ISO 10936-2:2001)]
ICS 11.040.30; 37.020

In accordance with the provisions of Council Resolution 15/1993 this document is circulated in
the English language only.
Conformément aux dispositions de la Résolution du Conseil 15/1993, ce document est distribué
en version anglaise seulement.
To expedite distribution, this document is circulated as received from the committee secretariat.
ISO Central Secretariat work of editing and text composition will be undertaken at publication
stage.
Pour accélérer la distribution, le présent document est distribué tel qu'il est parvenu du
secrétariat du comité. Le travail de rédaction et de composition de texte sera effectué au
Secrétariat central de l'ISO au stade de publication.
THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS THEREFORE SUBJECT TO CHANGE AND MAY NOT BE
REFERRED TO AS AN INTERNATIONAL STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL, TECHNOLOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN NATIONAL REGULATIONS.
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 SUPPORTING DOCUMENTATION.
©
International Organization for Standardization, 2008

---------------------- Page: 1 ----------------------
ISO/DIS 10936-2
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall
not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the
unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
Copyright notice
This ISO document is a Draft International Standard and is copyright-protected by ISO. Except as permitted
under the applicable laws of the user's country, neither this ISO draft nor any extract from it may be
reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic, photocopying,
recording or otherwise, without prior written permission being secured.
Requests for permission to reproduce should be addressed to either ISO at the address below or ISO's
member body in the country of the requester.
ISO copyright office
Case postale 56  CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Reproduction may be subject to royalty payments or a licensing agreement.
Violators may be prosecuted.
©
ii ISO 2008 – All rights reserved

---------------------- Page: 2 ----------------------
ISO/DIS 10936-2
Contents Page
Foreword .iv
1 Scope.1
2 Normative references.1
3 Definitions .1
4 Requirements for optical radiation hazard .1
4.1 General .1
4.2 Determination of classification Group .1
4.3 Requirements for Group 1 instruments .2
4.4 Requirements for Group 2 instruments .2
4.4.1 General .2
4.4.2 Retinal protection device.2
4.4.3 Stability of Iight intensity.2
5 Test methods .2
6 Additional information to be supplied by the manufacturer of Group 2 instruments.3
7 Marking.3
Annex A (informative) Example of information regarding maximum exposure guidelines to be
provided to the user during surgery .4
Annex B (informative) Fluid filled test eye .5
B.1 Description of the test eye.5
B.1.1 General.5
B.1.2 Main body.5
B.1.3 Pupil/lens holding disk .5
B.1.4 Intraocular lens implant.5
B.1.5 Rear window assembly.5
B.1.6 C-mount adapter.5
B.1.7 CCD camera .6
B.1.8 Critical specifications to insure proper optical performance.6
B.2 Assembly of the test eye .8
B.2.1 Filling the eye with fluid.8
B.2.2 Attaching the filled test eye onto the CCD camera.8
B.2.3 Calibration of the test eye image for size .8
B.2.4 Calibration of the test eye image for irradiance.8
B.3 Use of the test eye in making radiation measurements.9
Bibliography.10

© ISO 2008 – All rights reserved iii

---------------------- Page: 3 ----------------------
ISO/DIS 10936-2
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 10936-2 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 7,
Ophthalmic optics and instruments.
This second edition cancels and replaces the first edition (ISO 10936-2:2001) which has been technically
revised.
ISO 10936 consists of the following parts, under the general title Optics and photonics — Operation
microscopes:
⎯ Part 1: Requirements and test methods
⎯ Part 2: Light hazard from operation microscopes used in ocular surgery

iv © ISO 2008 – All rights reserved

---------------------- Page: 4 ----------------------
DRAFT INTERNATIONAL STANDARD ISO/DIS 10936-2

Optics and photonics — Operation microscopes — Part 2: Light
hazard from operation microscopes used in ocular surgery
1 Scope
This part of ISO 10936 specifies requirements and test methods for optical radiation hazards from operation
microscopes which are used during ophthalmic surgery.
NOTE General requirements for operation microscopes and test methods for these requirements are specified in
ISO 10936-1.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 10936-1, Optics and optical instruments — Operation microscopes — Part 1: Requirements and test
methods
ISO 15004-2:2007, Ophthalmic instruments — Fundamental requirements and test methods — Part 2: Light
hazard protection
3 Definitions
For the purposes of this part of ISO 10936 the following definitions apply.
3.1
Group 1 instrument
ophthalmic instrument for which no potential light hazard exists
3.2
Group 2 instrument
ophthalmic instrument for which a potential light hazards exists
4 Requirements for optical radiation hazard
4.1 General
Operation microscopes shall comply with the light hazard protection requirements given in ISO 15004-2.
4.2 Determination of classification Group
The operation microscopes shall be classified as a Group 1 or Group 2 instrument as defined in
ISO 15004-2:2007, Clause 4. The test methods given in this International Standard, i.e. ISO 10936-2,
Clause 5, shall be used to make this determination.
© ISO 2008 – All rights reserved 1

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ISO/DIS 10936-2
4.3 Requirements for Group 1 instruments
If status is determined to be Group 1, there are no further requirements.
4.4 Requirements for Group 2 instruments
4.4.1 General
If the status is determined to be Group 2, the operation microscope shall comply with the requirements of
ISO 15004-2:2007, 5.3. Compliance with ISO 15004-2:2007, 5.3 shall be verified using test methods given by
Clause 5 of this part of ISO 10936.
4.4.2 Retinal protection device
If the time to reach the aphakic weighted retinal radiant exposure maximum exposure guideline is < 30 min at
maximum output, a retinal protection device shall be installed in the coaxial light path and for each auxiliary
illumin
...

NORME ISO
INTERNATIONALE 10936-2
Deuxième édition
2010-01-15

Optique et photonique — Microscopes
chirurgicaux —
Partie 2:
Danger de la lumière provenant des
microscopes opératoires utilisés en
chirurgie oculaire
Optics and photonics — Operation microscopes —
Part 2: Light hazard from operation microscopes used in ocular surgery




Numéro de référence
ISO 10936-2:2010(F)
©
ISO 2010

---------------------- Page: 1 ----------------------
ISO 10936-2:2010(F)
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Publié en Suisse

ii © ISO 2010 – Tous droits réservés

---------------------- Page: 2 ----------------------
ISO 10936-2:2010(F)
Avant-propos
L'ISO (Organisation internationale de normalisation) est une fédération mondiale d'organismes nationaux de
normalisation (comités membres de l'ISO). L'élaboration des Normes internationales est en général confiée
aux comités techniques de l'ISO. Chaque comité membre intéressé par une étude a le droit de faire partie du
comité technique créé à cet effet. Les organisations internationales, gouvernementales et non
gouvernementales, en liaison avec l'ISO participent également aux travaux. L'ISO collabore étroitement avec
la Commission électrotechnique internationale (CEI) en ce qui concerne la normalisation électrotechnique.
Les Normes internationales sont rédigées conformément aux règles données dans les Directives ISO/CEI,
Partie 2.
La tâche principale des comités techniques est d'élaborer les Normes internationales. Les projets de Normes
internationales adoptés par les comités techniques sont soumis aux comités membres pour vote. Leur
publication comme Normes internationales requiert l'approbation de 75 % au moins des comités membres
votants.
L'attention est appelée sur le fait que certains des éléments du présent document peuvent faire l'objet de
droits de propriété intellectuelle ou de droits analogues. L'ISO ne saurait être tenue pour responsable de ne
pas avoir identifié de tels droits de propriété et averti de leur existence.
L'ISO 10936-2 a été élaborée par le comité technique ISO/TC 172, Optique et photonique, sous-comité SC 7,
Optique et instruments ophtalmiques.
Cette deuxième édition annule et remplace la première édition (ISO 10936-2:2001), qui a fait l'objet d'une
révision technique.
L'ISO 10936 comprend les parties suivantes, présentées sous le titre général Optique et photonique —
Microscopes chirurgicaux:
⎯ Partie 1: Exigences et méthodes d'essai
⎯ Partie 2: Danger de la lumière provenant des microscopes opératoires utilisés en chirurgie oculaire

© ISO 2010 – Tous droits réservés iii

---------------------- Page: 3 ----------------------
NORME INTERNATIONALE ISO 10936-2:2010(F)

Optique et photonique — Microscopes chirurgicaux —
Partie 2:
Danger de la lumière provenant des microscopes opératoires
utilisés en chirurgie oculaire
1 Domaine d'application
La présente partie de l'ISO 10936 spécifie les exigences et les méthodes d'essai relatives aux dangers du
rayonnement lumineux provenant des microscopes opératoires utilisés en chirurgie oculaire.
NOTE Les exigences générales relatives aux microscopes opératoires et aux méthodes d'essai sont spécifiées dans
l'ISO 10936-1.
2 Références normatives
Les documents de référence suivants sont indispensables pour l'application du présent document. Pour les
références datées, seule l'édition citée s'applique. Pour les références non datées, la dernière édition du
document de référence (y compris les éventuels amendements) s'applique.
ISO 10936-1, Optique et instruments d'optique — Microscopes chirurgicaux — Partie 1: Exigences et
méthodes d'essai
ISO 15004-2:2007, Instruments ophtalmiques — Exigences fondamentales et méthodes d'essai — Partie 2:
Protection contre les dangers de la lumière
3 Définitions
Pour les besoins du présent document, les définitions suivantes s'appliquent.
3.1
instrument du groupe 1
instrument ophtalmique pour lequel il n'existe aucun danger potentiel dû à la lumière et dont on peut
démontrer qu'il répond aux exigences de l'ISO 15004-2:2007, 5.2
NOTE Adapté de l'ISO 15004-2:2007.
3.2
instrument du groupe 2
instrument ophtalmique pour lequel il existe un danger potentiel dû à la lumière et qui ne répond pas aux
exigences de l'ISO 15004-2:2007, 5.2
NOTE Adapté de l'ISO 15004-2:2007.
© ISO 2010 – Tous droits réservés 1

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ISO 10936-2:2010(F)
4 Exigences relatives aux dangers du rayonnement lumineux
4.1 Général
...

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