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INTERNATIONAL ISO
STANDARD 10936-L
Seconcl eclition
20L7-08

Optics and photonics Operation

microscopes -
-
Part 1:
L Requirements and test methods
Optique et photonique Microscopes chirurgicaux
- -
Partie L: Exigences et, mdthodes d'essai

Reference number
ISO 10936-1:2017(E)

@ ISO 2017
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ISO 10936-L:2017(E)

L)

& COPYRIGHT PROTECTED DOCUMENT

O IS0 2017, Published in Switzerland
All rights t'eserved. t.Jnless othet'wise specified, no part of this publication may be leproduced or utilized otherwise in any fblm
or by any means, electronic or mechanical, including photocopying, or posting on tl')e interne[ or an intt'anet, without prior
written permission. Permission c;rn be requested fl'om either IS0 at the address below or IS0's member body in the country of
the requester.
lS0 copylight office
Ch. de Blandonnet B . CP 401
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Tel. +41 22749 01, 1L
Fax +41 22749 09 47
copyright@ iso.org
www.iso.org

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ISO 10936-t:2017(E)

Contents Page

Foreword.,.. tv
1 Scope.. .
1
7
1
3 1
4 2
2
2
2
2
5 2
.)
ra Cirecking the optical and mechanical specifications...,............. 2
5,3 2
5.4 Checking the safety....,. 2

L 6 2
Bibliography . .
4

O IS0 2017 - All rights reserved iii

 ISO 10936-L:20L7{E)

Foreword
IS0 (the International 0rganization for StandardizationJ is a worldwide federation of national standards
bodies (lSO member bodiesJ. 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 IS0, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission IIECJ on all matters of
electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part L. In particular the different approval criteria needed for the
different types of IS0 documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www,isg.or#directivesJ.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. IS0 shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received fsee www,iso.grg/patents),
L Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the voluntary nature of standards, the meaning of IS0 specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WT0l principles in the Technical Barriers to Trade (TBT) see the following
URL: w ww.iso.ors /iso /foreword.html.

This document was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee
SC 5, Microscopes and endoscopes.

This second edition cancels and replaces the first edition (lS0 10935-1:2000J, which has been
technically revised.

The main changes compared to the previous edition are as follows:

the normative references and the title have been updated;

note from environmental conditions (43J has been removed;

safety requirements (a.al have been updated;

L the requirement depths of field and total visual magnification (see Table L) have been clarified.

A list of all parts in the IS0 70936 series can be found on the ISO website.

iv O ISO 2017 - All rights reserved

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INTERNATIONAL STANDARD ISO 10936-122017(E)

optics and photonics operation microscopes

- -
Part 1:
Requirements and test methods

1 Scope
Ttris docr'rment specifies requirements and ref'ers to test methods fbr operation microscopes
used for
observation dr.rring surgical operatiou ancl treatment of patients,

It does not apply to accessories, e.g. photographic cameras.

NOTE Specific reqttirem_erts with regarcl to optical racliation hazards from operation microscopes used in
ocular surgery are given in ISO 10936-2.

L 2 Normative references
The fbllowing documents are referred to in the text in such a way that some or
all of their content
con.stitutes requirements of this document. For clated references, only the edition
cited applies. F6r
undated references, the latest edition of the ref'erenced document (including
,-"na-entsJ applies.
"ny
ISo 79++' 0ptics and optical instruments Reference wavelengths
-
IS0 8039, Microscopes values, tolerances and symbols
- for magnification
lso 9022 (all partsJ, optics and photonics Environmental test methods
-
IS0 10934 (all partsl, optics and optical instruments vocabulary
- for microscopy
ISO 1'5227, )ptics and optical instruments Microscopes Testing of stereomicroscopes
- -
IEC 60601-1 Medical electrical equipment Part L: General requirements
performance - for basic safety and essential

3 Terms and definitions

L For the purposes of this document, the terms and definitions given in ISO
8039,lSO t}g34 (all partsJ
and the following apply.

IS0 and IEC maintain terminological clatabases for use in stanciarciization at

the following acldresses:
IEC Electropedia: available at http://www.electropedia,org/
ISO OnIine browsing platform: available at hUp,.//:arw-rryas_it o{g/obp
3.1
operation microscope
s-tereomicroscope used for observation of surgical and other medical procedures,
consisting of an
illumination system anrl an observation system,lncluding objective lens, variable
or fixed power optical
system, observation tube and eyepieces

EXAMPLE Colposcopes.

O IS0 2017 - All righrs reserved

1
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ISO 10936-t:20L7(E)

4 Requirements

4.1 General
The operation microscope shall conform to the requirements in 42,4.3 and 4.4.

All requirements given below are minimum requirements. They apply to the reference wavelength
according to ISo 7944.

4.2 Optical and mechanical requirements

The reouirements in Table 1 aoolv.

Testing of optical and mechanical requirements shall be carried out in accordance with 5.2.

4.3 Environmental conditions

The operation microscope shall conform to the environmental requirements given in IEC 60601-1.

4,4 Safety
The requirements of IEC 60601-1 shall apply.

5 Test methods

5.1 General
All tests specified in this document are type tests.

5.2 Checking the optical and mechanical specifications

The requirements in 4.2 shall be checked with measuring devices the measuring uncertainty of which
shall be smaller than 10 %o of the value to be determined in accordance with ISO 15227.

Measurements shall be carried out in accordance with general rules of statistical evaluation.

5.3 Checking the environmental conditions

L Testing of environmental conditions shall be carried out in accordance with ISO 9022 (all parts).

5.4 Checking the safety

Testing of saf'ety shall be carried out in accordance with IEC 60601-1.

6 Marking
The operation microscope shall be permanently marked with at Ieast the markings according to
IEC 60601-1.

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ISO 10936-t:2017(E)

Table 1 * Requirements for optical and mechanical specifications

Criterion
lerance of total magnification
t 7,5 o/o

Difference in magnification between left and right optical

< 1,5 0/o

Difference in axis between vertical

< 15',
leftancl right optical systentsb
horizontal:t convergence < 45',
divergence < 10'
Shift of focusing planes by magnification change axial object plane
.t <3 c,d
Focus difference between left and right optical systerns
Dr/*a1,5.D. c

At highest magnification the resolvi ng power in the centre of the field should be a
minimum of 1800.N/ line pairs/mm
Difference ir.r imaging rotation between right and left images <z
Eyepiece diffcrence in exit pupil height between left anri right < 1,5 mm at 0 D on the di-
optical systenls optre scale
calibration error of a dioptre scale, if used 10,25 D at 0 D on the diop-
L minintum range for illary distance
tre scale
55 mm to 75 mm
minimum adjr.rstment range general +5Dro-5D
high eye point +2Dto-4D
a 'l'his requirement does not apply to those
operation r.nicroscopes whele the mechanical axes of the eyepieces are
parallel to each other due to the clesign,
b lncluding a 10 x eyepiece at 0 D acljustment.
c The admissible axial shift oFthe focusing plane is deternlined by:

D,=J
,
1.

2.NA""+ 7.M TOTVIS NA

where

D is the depth of field, in nrillimetres;

,
M is the total visual magnification;
roru,,
). is the waveiength, in millimetres;
NA is the numerical aperture.

The second part of this equation is

t the resolution of the .f

ba>-eci on ev e 2,
,, ,S0 is the shift olobject plane, il nrillimetres.

@ ISO 2017 - All rights reserved

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Bibliography

t1] ISO 1 0936-2 , Optics and photonics

- 1peration microscopes
- Part 2: Light hazard from operation
microscopes used in octtlar surgery

l2l IS0 11883, Optics and optical instruments

- Microscopes
- Marking oJ.stereomicroscopes

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ISO 10936-L:2O17(E)

ICS 11.0403A;37.020
Price based on 4 pages

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