Ophthalmic instruments -- Fundamental requirements and test methods

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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
---------------------- Page: 1 ----------------------
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. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2015 – All rights reserved
---------------------- Page: 2 ----------------------
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 Emission limits for determination of Group 1 classification ........................................................................... 8

5.4.1 Continuous wave instruments ............................................................................................................................. 8

5.4.2 Pulsed and time-limited instruments ............................................................................................................ 9

5.4.3 Limit for multiple source instruments .......................................................................................................11

5.5 Emission and exposure limit values for Group 2 instruments ...................................................................11

5.5.1 Continuous wave instruments ..........................................................................................................................11

5.5.2 Pulsed and time-limited instruments .........................................................................................................12

5.5.3 Multiple source instruments ..............................................................................................................................15

6 Test methods ..........................................................................................................................................................................................................16

6.1 General ........................................................................................................................................................................................................16

6.2 Measurements made to classify instruments into Group 1 or Group 2 ..............................................16

6.3 Group 2 instruments: Measurements ..............................................................................................................................16

6.4 Determination of area ....................................................................................................................................................................17

6.5 Group 2 instruments: Determination of time and number of pulses to reach

recommended maximum exposure ...................................................................................................................................17

6.5.1 Determination of time to reach the recommended maximum exposure for

weighted corneal and lenticular ultraviolet radiation radiant exposure, t .........

max 17
6.5.2 Determination of time to reach the recommended maximum exposure for
unweighted corneal and lenticular ultraviolet radiation radiant exposure,

for t < 1 000 s, t .......................................................................................................................................................

max 17
6.5.3 Determination of time to reach the recommended maximum exposure for

photochemical aphakic retinal radiant exposure, t .................................................................

max 18
6.5.4 Determination of the number of pulses necessary to reach the
recommended maximum exposure for photochemical aphakic retinal

radiant exposure, n (for pulsed instruments).............................................................................18

max

7 Information supplied by the manufacturer ..........................................................................................................................18

Annex A (normative) Spectral weighting functions ...........................................................................................................................21

Annex B (informative) Product-related International Standardsfor ophthalmic instruments

to which ISO 15004-2 appliesand which contain a specific light hazard section ...........................26

Annex C (informative) Measurement instruments .............................................................................................................................27

Annex D (normative) Measurement methods for radiance/irradiance .......................................................................31

Annex E (informative) Guidance on the direct measurement of irradiance ............................................................36

Annex F (informative) Classification flowchart ......................................................................................................................................38

Annex ZA (informative) Relationship between this European Standard and theEssential

Requirements of EU Directive 93/42/EEC ..............................................................................................................................39

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

Bibliography .............................................................................................................................................................................................................................40

iv © ISO 2015 – All rights reserved
---------------------- Page: 4 ----------------------
ISO/FDIS 15004-2:2015(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.

The procedures used to develop this document and those intended for its further maintenance are

described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the

different types of ISO documents should be noted. This document was drafted in accordance with the

editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).

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. 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 (see www.iso.org/patents).

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 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 information

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 (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
© ISO 2015 – All rights reserved v
---------------------- Page: 5 ----------------------
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. It is applicable to all ophthalmic instruments that direct optical radiation into or at the eye

and for which there is a light hazards requirement section within their respective International Standards.

It is also applicable to all new and emerging ophthalmic instruments that direct optical radiation into or

at the eye, as well as to those portions of therapeutic or surgical systems that direct optical radiation into

or at the eye for diagnostic, illumination, measurement, imaging or alignment purposes.

This part of ISO 15004 does not apply to radiation that is intended for treatment of ocular tissues.

NOTE 1 In the case of the treatment beams of therapeutic devices, when conducting risk assessments for non-

target tissues, the limits given in this International Standard can be applied to the treatment beam.

Where vertical (instrument-specific) International Standards contain specific light hazard requirements

different from those given in this part of ISO 15004, then those in the vertical International Standard

take precedence.

This part of ISO 15004 classifies ophthalmic instruments into either Group 1 or Group 2 in order to

distinguish instruments that are non-hazardous from those that are potentially hazardous.

NOTE 2 The emission limits are based on the International Commission on Non-Ionizing Radiation Protection

(ICNIRP) guidelines for human exposure to optical radiation. The limits and guidelines in this International

Standard also take account of the likelihoods that eyes might be dilated and that eyes and heads might be

[1]
stabilized during ophthalmic examinations. See Reference.
2 Normative references

The following documents, in whole or in part, are normatively referenced in this document and are

indispensable for its application. For dated references, only the edition cited applies. For undated

references, the latest edition of the referenced document (including any amendments) applies.

ISO 15004-1, Ophthalmic instruments — Fundamental requirements and test methods — Part 1: General

requirements applicable to all ophthalmic instruments
3 Terms, definitions and symbols
3.1 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 15004-1 and the following apply.

© ISO 2015 – All rights reserved 1
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ISO/FDIS 15004-2:2015(E)
3.1.1
aperture
aperture stop
opening that defines the area over which average optical emission is measured

Note 1 to entry: For spectral irradiance measurements this opening is usually the entrance of a small sphere

placed in front of the radiometer/spectroradiometer entrance slit.
3.1.2
continuous wave radiation source
CW radiation source

radiation source that is, or can be, operated with a continuous output for a time that can be greater than

0,25 s (i.e. a non-pulsed radiation source)
3.1.3
dose-limited instrument

ophthalmic device, whose emission exceeds the Group 1 dose-rate (irradiance) limits, but through its

design and construction cannot expose any given eye to radiation that reaches the cumulative exposure

limits given in6.5 and Table 5 within a 24-hour period
Note 1 to entry: This instrument would then be a Group 1 instrument.
3.1.4
effective aperture
portion of the aperture that limits the amount of light delivered to the retina

Note 1 to entry: For an obscured or non-circular aperture, it has an area equivalent to that of a non-obscured

circular aperture.
3.1.5
endoilluminator

device consisting of a light source and an associated fibre optic light guide that is intended for insertion

into the eye to illuminate any portion of the interior of the eye
3.1.6
field-of-view

conical solid angle as “seen” by the detector, such as the eye or the radiometer/spectroradiometer, out

of which the detector receives radiation

Note 1 to entry: The field-of-view denotes the angle over which radiance is averaged (sampled) and should not be

confused with the angular subtense of the source α which denotes source size.
3.1.7
Group 1 instrument

ophthalmic instrument for which no potential light hazard exists and that can be shown to fulfil the

requirements of 5.2
3.1.8
Group 2 instrument

ophthalmic instrument for which a potential light hazard exists and that does not fulfil the requirements

of 5.2 but does fulfil the requirements of 5.3
3.1.9
irradiance

〈at a point on a surface〉 quotient of the radiant power dΦ incident on an element of a surface containing

the point, by the area dA of that element, i.e
E =
2 © ISO 2015 – All rights reserved
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ISO/FDIS 15004-2:2015(E)

Note 1 to entry: Irradiance is expressed in units of watts per square centimetre, W/cm .

3.1.10
manufacturer
natural or legal person who places the ophthalmic instrument on the market
3.1.11
maximum intensity

highest optical radiation emissions the instrument is capable of delivering under any and all conditions

3.1.12
operation microscope

stereo-microscope used for observation of surgical and other medical procedures, consisting of an

illumination system and an observation system, including objective lens, variable or fixed power optical

system, observation tube and eyepieces
3.1.13
optical radiation hazard
risk of damage to the eye by exposure to optical radiant energy
Note 1 to entry: Ultraviolet, visible, or infrared.
3.1.14
photoretinitis

photochemically-induced injury to the retina resulting from a very intense retinal radiant exposure

Note 1 to entry: The term photic maculopathy is also used to describe photoretinitis in the fovea-macular area

of the retina.
3.1.15
pulsed light source

light source that delivers its energy in the form of a single exposure of known duration of 0,25 s or less

or a train of pulses where each pulse in that train has a duration of less than 0,25 s

Note 1 to entry: A light source with a continuous train of pulses or modulated radiant energy where the peak

radiated power is at least ten times the minimum radiated power is considered to be a pulsed light source.

Note 2 to entry: The nominal pulse duration, Δt, for pulsed instrument evaluation is determined by the time interval

equal to the full width at half maximum of the pulse. The energy integration time, t, is the full pulse width for an

individual pulse, and for multiple pulses, it is the time that includes each individual pulse and combination of pulses.

3.1.16
radiance

〈in a given direction at a given point of a real or imaginary surface〉 quantity defined by the formula

dA××cosθ dΩ
where

dΦ is the radiant power transmitted by an elementary beam passing through the given point

and propagating in the solid angle dΩ containing the given direction;
dA is the area of a section of that beam containing the given point;
θ is the angle between the normal to that section and the direction of the beam

Note 1 to entry: The same definition holds for the time-integrated radiance L if, in the formula for L, the radiant

power dΦ is replaced by the radiant energy dQ.
© ISO 2015 – All rights reserved 3
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ISO/FDIS 15004-2:2015(E)

Note 2 to entry: Radiance is expressed in watts per steradian square centimetre, W/(sr⋅cm ); time-integrated

radiance is expressed in Joules per steradian square centimetre, J/(sr⋅cm ).
3.1.17
radiant exposure

〈at a point of a surface, for a given duration〉 quotient of the radiant energy, dQ, incident on an element of

a surface containing the point over the given duration by unit area dA of that element

H =

Note 1 to entry: Equivalently, the radiant exposure is defined as the integral of the irradiance, E, at a given point

over a given duration, Δt
HE=×dt

Note 2 to entry: Radiant exposure is expressed in Joules per square centimetre, J/cm .

3.1.18
scanning instrument

instrument that emits radiation having a time-varying direction, origin or pattern of propagation with

regard to a stationary frame of reference
3.1.19
spectral irradiance

quotient of the spectral radiant power dΦ (λ) in a wavelength interval dλ, incident on an element of a

surface, by the area dA of that element and by the wavelength interval dλ
dϕλ
E =
dA×dλ

Note 1 to entry: Spectral irradiance is expressed in watts per square centimetre nanometre, W/(cm nm).

3.1.20
spectral radiance

〈for a wavelength interval dλ, in a given direction at a given point〉 ratio of the spectral radiant power

dΦ (λ) passing through that point and propagating within the solid angle dΩ in the given direction, to the

product of the wavelength interval dλ and the areas of a section of that beam on a plane perpendicular

to this direction (cos θ dA) containing the given point and to the solid angle dΩ

dϕλ
L =
dA××cosθλddΩ×

Note 1 to entry: Spectral radiance is expressed in watts per steradian square centimetre nanometre, W/(sr·cm

nm).
3.1.21
time-limited instrument
ophthalmic device, whose maximum exposure duration is limited and known
3.2 Symbols
Symbols, quantities and units are listed in Table 1.
4 © ISO 2015 – All rights reserved
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ISO/FDIS 15004-2:2015(E)
Table 1 — Symbols, quantities and units
Symbol Quantity Unit
E irradiance (at a point on a surface) W/cm
E spectral irradiance W/(cm ⋅nm)

L radiance (in a given direction at a given point of a real or imaginary surface) W/(sr⋅cm )

L spectral radiance (for a wavelength interval dλ, in a given direction at a given point) W/(sr·cm nm)

L time-integrated radiance J/(sr⋅cm )
H radiant exposure (at a point of a surface, for a given duration) J/cm
H spectral radiant exposure J/(cm ⋅nm)
E S(λ) weighted corneal and lenticular ultraviolet radiation irradiance W/cm
S-CL
E unweighted corneal and lenticular ultraviolet radiation irradiance W/cm
UV-CL
E A(λ) weighted retinal irradiance W/cm
A-R
E unweighted corneal and lenticular infrared radiation irradiance W/cm
IR-CL
E unweighted anterior segment visible and infrared radiation irradiance W/cm
VIR-AS
E R(λ) weighted retinal visible and infrared radiation thermal irradiance W/cm
VIR-R
L A(λ) weighted retinal radiance W/(sr⋅cm )
A-R
L A(λ) weighted retinal time-integrated radiance J/(sr⋅cm )
i,A-R

L R(λ) weighted, retinal visible and infrared radiation time-integrated radiance J/(sr⋅cm )

i,VIR-R
L R(λ) weighted retinal visible and infrared radiation radiance W/(sr⋅cm )
VIR-R
H R(λ) weighted retinal visible and infrared radiation radiant exposure J/cm
VIR-R
H unweighted corneal and lenticular infrared radiation radiant exposure J/cm
IR-CL

H unweighted anterior segment visible and infrared radiation radiant exposure J/cm

VIR-AS

H S(λ) weighted corneal and lenticular ultraviolet radiation radiant exposure J/cm

S-CL
H unweighted corneal and lenticular ultraviolet radiation radiant exposure J/cm
UV-CL
H A(λ) weighted retinal radiant exposure J/cm
A-R
S(λ) ultraviolet radiation hazard weighting function (see Annex A) —
A(λ) aphakic photochemical hazard weighting function (see Annex A) —
B(λ) blue-light hazard function (see Annex A) —

R(λ) visible and infrared radiation thermal hazard weighting function (see Annex A) —

Δλ summation interval nm
exposure time; also:
energy integration time;
t s

for pulsed instruments: the time to deliver a full pulse width for an individual pulse,

and for multiple pulses, the time that includes each individual pulse and combination

of pulses
Δt pulse width up to a time of 0,25 s s
E ·t spectral radiant exposure J/(cm nm)
(E ·Δt) spectral radiant exposure at time Δt J/(cm nm)
v velocity of the scanning beam on the irradiated tissue surface mm/s
© ISO 2015 – All rights reserved 5
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ISO/FDIS 15004-2:2015(E)
4 Classification

For the purposes of this part of ISO 15004, ophthalmic instruments are classified into two groups in

order to separate those instruments that are capable of presenting a potential hazard from those which

do not. The two groups are named Group 1 and Group 2. They are defined as follows:

a) Group 1 instruments: ophthalmic instruments for which no potential light hazard exists.

Ophthalmic instruments that can be shown to fulfil the requirements of 5.2.

b) Group 2 instruments: ophthalmic instruments for which a potential light hazard exists. Those

ophthalmic instruments that do not fulfil the requirements of 5.2 but do fulfil those of 5.3.

NOTE The classification process is outlined in the classification flowchart (see Annex F).

5 Requirements
5.1 General

Ophthalmic instruments shall be so designed that the energy in all wavelengths be attenuated as much

as possible in keeping with the intended use of the instrument.

If another device is used in combination with an ophthalmic instrument, the connecting system shall

not degrade the optical radiation safety of either instrument, nor shall the optical radiation hazards of

the combined system exceed the levels that are given in this part of ISO 15004.
5.2 Requirements for classification as a Group 1 instrument
5.2.1 General

An ophthalmic instrument shall be classified in Group 1 if any or all of the following criteria apply.

a) An International Standard exists for the instrument type but no light hazard requirements are

included in that International Standard.

b) Its components, e.g. lamps, light-emitting diodes, non-removable filters, lenses, fibres, prevent

emissions in excess of the limits specified for instruments in Group 1 and certification of this

exists. Such instruments shall be classified as Group 1 by virtue of the test certification by the

manufacturer of the components themselves without the need for further measurements. If such

components prevent some, but not all emissions to exceed the limits specified for Group 1, then

measurements shall be required only for those parameters in Tables 2 and 3 where the components

do not prevent the limits from being exceeded.

c) Its emission values are equal to or less than the limit values given in 5.4. The test methods used for

determination of compliance shall be in accordance with 6.2.

d) It is a dose-limited instrument by virtue of its construction and design, as defined in 3.1.3.

Existing International Standards that contain light hazard requirements are listed in Annex B.

The limit values to determine Group 1 classification are based upon an expected exposure time for

the instrument type under consideration. The Group 1 limit values given in 5.4 are based upon a 1 h

exposure. These limits apply to all instruments except operation microscopes, endoilluminators, and

instruments designed for continuous exposure. For instruments designed for continuous exposure,

the limits should be reduced by a factor equal to one half of the continuous exposure time, in hours,

associated with the intended use of the instrument.

Time-limited instruments fulfil the Group 1 requirement for retinal photochemical aphakic light hazard

weighted retinal irradiance, E , if their maximum exposure duration is less than the time to reach the

A-R

recommended maximum exposure for photochemical aphakic retinal exposure, t , as per 6.5.3.

max
6 © ISO 2015 – All rights reserved
---------------------- Page: 11 ----------------------
ISO/FDIS 15004-2:2015(E)
5.2.2 Requirements for classification as Group 1 for a scanning instrument

An ophthalmic instrument that images the retina or the anterior segment of the eye through the use

of a small moving irradiated area shall be classified as a Group 1 instrument for retinal visible and

infrared radiation thermal hazard if the total radiation energy entering the eye creates a weighted

retinal visible and infrared radiation thermal irradiance less than or equal to limit given by Table 5, row

5.5.2.2, for a retinal image size of 0,03 mm and an exposure duration of 10 s, i.e. 1874 J/cm . Thus the

energy entering the eye shall be less than or equal to 1,32 mW.

An ophthalmic instrument that scans the retina shall be classified as a Group 1 instrument for

photochemical aphakic light hazard if the value of the aphakic weighted retinal irradiance, E , is equal

A-R

to or less than the limit given by Table 2, row 5.4.1.3, where the value of the retinal spectral irradiance,

E , used to calculate E shall be found by dividing the power entering the eye at each wavelength

λ A-R
interval, Δλ, given in W, by the area of the irradiated retina, given in cm .
5.3 Requirements for Group 2 instruments

5.3.1 If an instrument does not fulfil all requirements for a Group 1 instrument, it shall be checked for

compliance with Group 2 requirements only for those hazards for which it did not fulfil the requirements

of Group 1. The reporting requirements of 7 b) need only be complied with if Group 1 requirements are

not fulfilled for Table 2, row 5.4.1.1 - Weighted corneal and lenticular ultraviolet radiation irradiance or

row 5.4.1.2 – Unweighted corneal and lenticular ultr
...

© 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

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
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Fax + 41 22 749 09 47
E‐mail copyright@iso.org
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Reproduction may be subject to royalty payments or a licensing agreement.
Violators may be prosecuted.
ii © ISO 2015 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/FDIS 15004-2:2015(E)
Contents Page
© ISO 2015 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO/FDIS 15004-2:2015(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 StandardsThe procedures used to develop this document and those intended for its

further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval

criteria needed for the different types of ISO documents should be noted. This document was drafted in

accordance with the editorial rules given inof the ISO/IEC Directives, Part 2

(see www.iso.org/directives.).

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. 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 (see www.iso.org/patents).

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 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
---------------------- Page: 4 ----------------------
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 or at the

eye and for which there is a light hazards requirement section within their respective International

Standards. It is also applicable to all new and emerging ophthalmic instruments that direct optical

radiation into or at the eye, as well as to those portions of therapeutic or surgical systems that direct

optical radiation into or at the eye for diagnostic, illumination, measurement, imaging or alignment

purposes.

This part of ISO 15004 does not apply to radiation that is intended for treatment of ocular tissues.

NOTE 1 In the case of the treatment beams of therapeutic devices, when conducting risk assessments for non‐

target tissues, the limits given in this International Standard can be applied to the treatment beam.

Where vertical (instrument‐specific) International Standards contain specific light hazard requirements

different from those given in this part of ISO 15004, then those in the vertical International Standard

shall take precedence.

This part of ISO 15004 classifies ophthalmic instruments into either Group 1 or Group 2 in order to

distinguish instruments that are non‐hazardous from those that are potentially hazardous.

NOTE 2 The emission limits are based on the International Commission on Non‐Ionizing Radiation Protection

(ICNIRP) guidelines for human exposure to optical radiation. The limits and guidelines in this

standardInternational Standard also take account of the likelihoods that eyes maymight be dilated and that eyes

[1 ]

and heads maymight be stabilisedstabilized during ophthalmic examinations. See Bibliography [Reference. ].

2 Normative references

The following documents, in whole or in part, are normatively referenced in this document and are

indispensable for its application. For dated references, only the edition cited applies. For undated

references, the latest edition of the referenced document (including any amendments) applies.

ISO 15004‐1, Ophthalmic instruments — Fundamental requirements and test methods — Part 1: General

requirementsrequirements applicable to all ophthalmic instruments
3 Terms, definitions and symbols
3.1 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 15004‐1 and the following

apply.
3.1.1
aperture
aperture stop
opening that defines the area over which average optical emission is measured
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ISO/FDIS 15004-2:2015(E)

Note 1 to entry: For spectral irradiance measurements this opening is usually the entrance of a small sphere

placed in front of the radiometer/spectroradiometer entrance slit.
3.1.2
continuous wave radiation source
CW radiation source

radiation source that is, or can be, operated with a continuous output for a time that can be greater than

0,25 s (i.e. a non‐pulsed radiation source)
3.1.3
dose-limited instrument

ophthalmic device, whose emission exceeds the Group 1 dose‐rate (irradiance) limits, but through its

design and construction cannot expose any given eye to radiation that reaches the cumulative exposure

limits given inin6.5 and Table 5 and 6.5 within a 24‐hour period
Note 1 to entry: This instrument would then be a Group 1 instrument.
3.1.4
effective aperture
portion of the aperture that limits the amount of light delivered to the retina

Note 1 to entry: For an obscured or noncircularnon‐circular aperture, it has an area equivalent to that of a non‐

obscured circular aperture.
3.1.5
endoilluminator

device consisting of a light source and an associated fibre optic light guide that is intended for insertion

into the eye to illuminate any portion of the interior of the eye
3.1.6
field-of-view

conical solid angle as “seen” by the detector, such as the eye or the radiometer/spectroradiometer, out

of which the detector receives radiation

Note 1 to entry: The field‐of‐view denotes the angle over which radiance is averaged (sampled) and should not

be confused with the angular subtense of the source α which denotes source size.

3.1.7
Group 1 instrument

ophthalmic instrument for which no potential light hazard exists and that can be shown to fulfil the

requirements of 5.2
3.1.8
Group 2 instrument

ophthalmic instrument for which a potential light hazard exists and that does not fulfil the

requirements of 5.2 but does fulfil the requirements of 5.3
3.1.9
irradiance

〈at a point on a surface〉 quotient of the radiant power ddΦ incident on an element of a surface

containing the point, by the area dA of that element, i.e.
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ISO/FDIS 15004-2:2015(E)
E= (1)

Note 1 to entry: Irradiance is expressed in units of watts per square centimetre, W/cm .

3.1.10
manufacturer
natural or legal person who places the ophthalmic instrument on the market
3.1.11
maximum intensity

highest optical radiation emissions the instrument is capable of delivering under any and all conditions

3.1.12
operation microscope

stereo‐microscope used for observation of surgical and other medical procedures, consisting of an

illumination system and an observation system, including objective lens, variable or fixed power optical

system, observation tube and eyepieces
3.1.13
optical radiation hazard

risk of damage to the eye by exposure to optical radiant energy – ultraviolet, visible, or infrared

Note 1 to entry: Ultraviolet, visible, or infrared.
3.1.14
photoretinitis

photochemically‐induced injury to the retina resulting from a very intense retinal radiant exposure

Note 1 to entry: The term photic maculopathy is also used to describe photoretinitis in the fovea‐macular area

of the retina.
3.1.15
pulsed light source

light source that delivers its energy in the form of a single exposure of known duration of 0,25 s or less

or a train of pulses where each pulse in that train has a duration of less than 0,25 s

Note 1 to entry: A light source with a continuous train of pulses or modulated radiant energy where the peak

radiated power is at least ten times the minimum radiated power is considered to be a pulsed light source.

Note 2 to entry: The nominal pulse duration, tΔt, for pulsed instrument evaluation is determined by the time

interval equal to the full width at half maximum of the pulse. The energy integration time, t, is the full pulse width

for an individual pulse, and for multiple pulses, it is the time that includes each individual pulse and combination

of pulses.
3.1.16
radiance

〈in a given direction at a given point of a real or imaginary surface〉 quantity defined by the

equationformula
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ISO/FDIS 15004-2:2015(E)
L= (2)
dA´´cos d
where

d is the radiant power transmitted by an elementary beam passing through the given point and

propagating in the solid angle d containing the given direction;
dA is the area of a section of that beam containing the given point;
 is the angle between the normal to that section and the direction of the beam.

dΦ is the radiant power transmitted by an elementary beam passing through the given point and

propagating in the solid angle dΩ containing the given direction;
dA is the area of a section of that beam containing the given point;

θ is the angle between the normal to that section and the direction of the beam

Note 1 to entry: The same definition holds for the time‐integrated radiance L if, in the equationformula for L,

the radiant power ddΦ is replaced by the radiant energy dQ.

Note 2 to entry: Radiance is expressed in watts per steradian square centimetre, W/(sr⋅cm ); time‐integrated

radiance is expressed in Joules per steradian square centimetre, J/(sr⋅cm ).
3.1.17
radiant exposure

〈at a point of a surface, for a given duration〉 quotient of the radiant energy, dQ, incident on an element

of a surface containing the point over the given duration by unit area dA of that element

H= (3)

Note 1 to entry: Equivalently, the radiant exposure is defined as the integral of the irradiance, E, at a given point

over a given duration, tΔt
HE=´dt (4)
D t

Note 12 to entry: Radiant exposure is expressed in Joules per square centimetre, J/cm .

3.1.18
scanning instrument

instrument that emits radiation having a time‐varying direction, origin or pattern of propagation with

regard to a stationary frame of reference.
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ISO/FDIS 15004-2:2015(E)
3.1.19
spectral irradiance

quotient of the spectral radiant power d ()dΦ (λ) in a wavelength interval d,dλ, incident on an

element of a surface, by the area dA of that element and by the wavelength interval ddλ

d 
E = (5)
dA´d

Note 1 to entry: Spectral irradiance is expressed in watts per square centimetre nanometre, W/(cm nm).

3.1.20
spectral radiance

〈for a wavelength interval d,dλ, in a given direction at a given point〉 ratio of the spectral radiant

power d ()dΦ (λ) passing through that point and propagating within the solid angle ddΩ in the

given direction, to the product of the wavelength interval ddλ and the areas of a section of that beam

on a plane perpendicular to this direction (cos θ dA) containing the given point and to the solid angle

ddΩ
d
L = (6)
dA´´cos d´d

Note 1 to entry: Spectral radiance is expressed in watts per steradian square centimetre nanometre,

. 2.
W/(sr·cm nm).
3.1.21
time-limited instrument
ophthalmic device, whose maximum exposure duration is limited and known
3.2 Symbols
Symbols, quantities and units are listed in Table 1.
Table 1 — Symbols, quantities and units
Symbol Quantity Unit
E irradiance (at a point on a surface) 2
W/cm
E E spectral irradiance 2
 λ W/(cm ⋅nm)

L radiance (in a given direction at a given point of a real or imaginary surface) 2

W/(sr⋅cm )

L L spectral radiance (for a wavelength interval d,dλ, in a given direction at a given . 2.

 λ W/(sr·cm n
point)
L time‐integrated radiance 2
i J/(sr⋅cm )
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ISO/FDIS 15004-2:2015(E)
H radiant exposure (at a point of a surface, for a given duration) 2
J/cm
H H spectral radiant exposure 2
 λ J/(cm ⋅nm)
E S()(λ) weighted corneal and lenticular ultraviolet radiation irradiance 2
S‐CL W/cm
E unweighted corneal and lenticular ultraviolet radiation irradiance 2
UV‐CL W/cm
E A()(λ) weighted retinal irradiance 2
A‐R W/cm
E unweighted corneal and lenticular infrared radiation irradiance 2
IR‐CL W/cm
E unweighted anterior segment visible and infrared radiation irradiance 2
VIR‐AS W/cm

E R()(λ) weighted retinal visible and infrared radiation thermal irradiance W/cm

VIR‐R
L A()(λ) weighted retinal radiance 2
A‐R W/(sr⋅cm )
L A()(λ) weighted retinal time‐integrated radiance 2
i,A‐R J/(sr⋅cm )

L R()(λ) weighted, retinal visible and infrared radiation time‐integrated radiance 2

i,VIR‐R J/(sr⋅cm )
L R()(λ) weighted retinal visible and infrared radiation radiance 2
VIR‐R W/(sr⋅cm )
H R()(λ) weighted retinal visible and infrared radiation radiant exposure 2
VIR‐R J/cm
H unweighted corneal and lenticular infrared radiation radiant exposure 2
IR‐CL J/cm
H unweighted anterior segment visible and infrared radiation radiant exposure 2
VIR‐AS J/cm

H S()(λ) weighted corneal and lenticular ultraviolet radiation radiant exposure 2

S‐CL J/cm
H unweighted corneal and lenticular ultraviolet radiation radiant exposure 2
UV‐CL J/cm
H A()(λ) weighted retinal radiant exposure 2
A‐R J/cm
S()(λ) ultraviolet radiation hazard weighting function (see Annex A) —
A()(λ) aphakic photochemical hazard weighting function (see Annex A) —
B()(λ) blue‐light hazard function (see Annex A) —

R()(λ) visible and infrared radiation thermal hazard weighting function (see Annex A) —

Δλ summation interval nm
exposure time; also:
energy integration time;
t s
for pulsed instruments: the time to deliver a full pulse width for an individual
pulse, and for multiple pulses, the time that includes each individual pulse and
combination of pulses
tΔt pulse width up to a time of 0,25 s s
spectral radiant exposure 2.
E E·t
J/(cm nm)
 λ
spectral radiant exposure at time tΔt 2.
(E tE·Δt
J/(cm nm)
 λ
v velocity of the scanning beam on the irradiated tissue surface mm/s
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ISO/FDIS 15004-2:2015(E)
4 Classification

For the purposes of this part of ISO 15004, ophthalmic instruments are classified into two groups in

order to separate those instruments that are capable of presenting a potential hazard from those which

do not. The two groups are named Group 1 and Group 2. They are defined as follows:

a) Group 1 instruments: ophthalmic instruments for which no potential light hazard exists.

Ophthalmic instruments that can be shown to fulfil the requirements of 5.2.

b) Group 2 instruments: ophthalmic instruments for which a potential light hazard exists. Those

ophthalmic instruments that do not fulfil the requirements of 5.2 but do fulfil those of 5.3.

NOTE The classification process is outlined in the classification flowchart (see Annex F).

5 Requirements
5.1 General

Ophthalmic instruments shall be so designed that the energy in all wavelengths be attenuated as much

as possible in keeping with the intended use of the instrument.

If another device is used in combination with an ophthalmic instrument, the connecting system shall

not degrade the optical radiation safety of either instrument, nor shall the optical radiation hazards of

the combined system exceed the levels that are given in this part of ISO 15004.
5.2 Requirements for classification as a Group 1 instrument
5.2.1 General

An ophthalmic instrument shall be classified in Group 1 if any or all of the following criteria apply.

a) An International Standard exists for the instrument type but no light hazard requirements are

included in that International Standard.

b) Its components, e.g. lamps, light‐emitting diodes, non‐removable filters, lenses, fibres, etc., prevent

emissions in excess of the limits specified for instruments in the Group 1 and certification of this

exists. Such instruments shall be classified as Group 1 by virtue of the test certification by the

manufacturer of the components themselves without the need for further measurements. If such

components prevent some, but not all emissions to exceed the limits specified for Group 1, then

measurements shall be required only for those parameters in Tables 2 and 3 where the

components do not prevent the limits from being exceeded.

c) Its emission values are equal to or less than the limit values given in 5.4. The test methods used for

determination of compliance shall be in accordance with 6.2.

d) It is a dose‐limited instrument by virtue of its construction and design, as defined in 3.1.3.

Existing International Standards that contain light hazard requirements are listed in Annex B. The limit

values to determine Group 1 classification are based upon an expected exposure time for the

instrument type under consideration. The Group 1 limit values given in 5.4 are based upon a 1 h

exposure. These limits apply to all instruments except operation microscopes, endoilluminators, and

instruments designed for continuous exposure. For instruments designed for continuous exposure, the

limits should be reduced by a factor equal to one half of the continuous exposure time, in hours,

associated with the intended use of the instrument.
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ISO/FDIS 15004-2:2015(E)

Time‐limited instruments fulfil the Group 1 requirement for retinal photochemical aphakic light hazard

weighted retinal irradiance, E , if their maximum exposure duration is less than the time to reach the

A‐R

recommended maximum exposure for photochemical aphakic retinal exposure, t , as per 6.5.3.

max
5.2.2 Requirements for classification as Group 1 for a scanning instrument

An ophthalmic instrument that images the retina or the anterior segment of the eye through the use of a

small moving irradiated area shall be classified as a Group 1 instrument for retinal visible and infrared

radiation thermal hazard if the total radiation energy entering the eye creates a weighted retinal visible

and infrared radiation thermal irradiance less than or equal to limit given by Table 5, row 5.5.2.2

(Table 5), for a retinal image size of 0,03 mm and an exposure duration of 10 s, i.e. 1874 J/cm. Thus the

energy entering the eye shall be less than or equal to 1,32 mW.

An ophthalmic instrument that scans the retina shall be classified as a Group 1 instrument for

photochemical aphakic light hazard if the value of the aphakic weighted retinal irradiance, E , is

A‐R

equal to or less than the limit given by Table 2, row 5.4.1.3 (Table 2),, where the value of the retinal

spectral irradiance, E,E, used to calculate E shall be found by dividing the power entering the eye

 λ A‐R

at each wavelength interval, ,Δλ, given in W, by the area of the irradiated retina, given in cm.

5.3 Requirements for Group 2 instruments

5.3.1 If an instrument does not fulfil all requirements for a Group 1 instrument, it shall be checked for

compliance with Group 2 requirements only for those hazards for which it did not fulfil the

requirements of Group 1. The reporting requirements of 7 b) need only be complied with if Group 1

requirements are not fulfilled for Table 2, row 5.4.1.1 ‐ Weighted corneal and lenticular ultraviolet

radiation irradiance (Table 2) or row 5.4.1.2 – Unweighted corneal and lenticular ultraviolet radiation

radiant exposure (Table 2) or row 5.4.1.3 ‐ Retinal photochemical aphakic light hazard, Weighted

retinal irradiance (Table 2)..

Visible light is necessary for diagnosis of ocular pathology, and thus is commonly used in instruments

such as direct and indirect ophthalmoscopes, slit‐lamp microscopes, operation microscopes and

endoilluminators. It is not reasonable to set limits on visible radiation that is needed for the diagnosis of

disease or for visualization during ocular surgery. A surgeon may have to exceed an exposure level that

is known to be potentially hazardous during an extended complicated surgery or a clinician may have to

exceed an exposure level that is known to be potentially hazardous during an extended ocular

examination for diagnosis of ocular pathology. With this in mind, the standard requires that the time to

reach a potentially hazardous exposure be given, rather than to set a limit, so that clinicians are

informed about potential optical radiation hazards that may be associated with the use of their

instruments should they need to use an amount of radiation that has a high likelihood of causing ocular

tissue damage.

5.3.2 A scanning instrument that does not fulfil the requirements of 5.2.2 for retinal visible and

infrared radiation thermal hazard shall be checked for compliance with Group 2 using the pulsed and

time‐limited instrument requirements, in Table 5, row 5.5.2.2 (Table 5).. The value of pulse width tΔt

to be used in row 5.5.2.2 shall be found using the scan velocity, v, and the linear dimension of the beam

cross‐section in the scanning direction at the retina, d, in the formula
Dt=

where v is the velocity of the scanning beam on the Irradiatedirradiated tissue surface expressed in

mm/s.
If the value of d is less than 0,03 mm, set d at 0,03 mm.
r r
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ISO/FDIS 15004-2:2015(E)

For beams with a non‐circular cross‐section, the value of d shall be determined by averaging the

maximum cross‐section length with the minimum cross‐section length. In this calculation, if the

maximum cross‐section length is greater than 1,2 mm, the value 1,2 mm shall be used as the maximum

cross‐section length.

When using the requirements of row 5.5.2.2 the value of N, the number of pulses, is the number of times

the scan passes over the circular aperture of 0,03 mm on the retina.

A scanning instrument that does not fulfil the requirements of 5.2.2 for photochemical aphakic light

hazard shall fulfil the requirements of 7 b) 1) for reporting time to reach the recommended maximum

exposure using the procedure of 6.5.3 in which the value of E shall be found using the procedure

A‐R
given in 5.2.2.
5.3.3 Group 2 instruments shall comply with the emission limits given in 5.5.

5.3.4 The test methods used for determination of compliance shall be in accordance with 6.3 and 6.4.

However, if components that are being used in the instrument, e.g. lamps, light‐emitting diodes, non‐

removable filters, lenses, fibres, etc., prevent some, but not all emissions specified for Group 2, then

provided that documentation of test certification of the respective components is available,

measurements shall be required only for those parameters in Tables 4 and 5 where the components do

not prevent the limits from being exceeded.

5.3.5 Where provision is made to vary the brightness of the Group 2 instrument, an indication of the

maximum intensity and fractions of maximum intensity shall be provided on the instrument.

5.3.6 Information shall be supplied with Group 2 instruments as specified in Clause 7.

5.4 Emission limits for determination of Group 1 classification
5.4.1 Continuous wave instruments

The emission limits specified in Table 2 relate to maximum corneal and lenticular or retinal irradiance

or instrument radiance as applied directly to the continuous wave instrument's criteria. To evaluate the

respective radiation hazard criteria, the equationsformulae given for them in Table 2 shall be used. See

Table 1 for an explanation of the quantities used in the equationsformulae and for associated units.

Table — 2 — Group 1 limit values for continuous wave instruments
Wavelength
Parameter EquationFormula Limit
5.4.1. Weighted corneal and lenticular
400
1 ultraviolet radiation irradiance, E
250 to 400 EE=´S ´
() 0,8 µW/cm
S‐CL
S‐CL 
250
The corneal and lenticular ultraviolet radiation irradiance shall
be evaluated by averaging the highest localized radiant power
incident upon a circular area with a diameter of 3 mm (0,07
cm ) at the corneal plane.
5.4.1. Unweighted corneal ultraviolet 400
2 radiation irradiance, E
2
360 to 400 EE=´
UV‐CL
1 mW/cm
UV-CL 
360
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ISO/FDIS 15004-2:2015(E)
The corneal and lenticular ultraviolet radiation irradiance shall
be evaluated by averaging the highest localized radiant power
incident upon a circular area with a diameter of 3 mm
(0,07 cm ) at the corneal plane.
5.4.1. Retinal photochemical aphakic light
700
3 hazard;
EE=´A ´ 2
305 to 700 ()
AR- å  440 µW/cm
305
Weighted retinal irradiance, E
A‐R
The corneal and lenticular ultraviolet radiationThe retinal
irradiance shall be evaluated by averaging the highest localized
radiant power incident upon a circular area with a diameter of
3 mm (0,07 cm) at the corneal plane.0,18 mm
−4 2
(2,54 × 10 cm ) on the retina. However, if the instrument is
intended to be used with an eye that is immobilized, a 0,03 mm
−6 2
(7,07 × 10 cm ) diameter aperture shall be used instead of a
0,18 mm diameter aperture.
For instruments that produce a uniform beam on the retina
with a diameter greater than 1 mm, a 1 mm diameter averaging
aperture may be used to evaluate retinal irradiance instead of
the apertures specified.
5.4.1. Unweighted corneal and lenticular 2500
4 infrared radiation irradiance, E
EE=´ 2
IR‐CL 915 to 2 500
å 60 mW/cm
IR-CL 
915
The corneal irradiance shall be evaluated by averaging the
radiant power incident upon the circular area with a diameter
−2 2
of 3,5 mm (9,6 × 10 cm ) at the corneal plane that is centred
on the location where the highest local radiant power is found.
5.4.1. Unweighted anterior segment visible
1200
5 and infrared radiation irradiance, E
EE=´ 2
380 to 1 200
VIR‐
å 4 W/cm
VIR-AS 
380
This limit only applies to instruments
The unweighted anterior segment irradiance shall be evaluated
that, in normal use, irradiate the eye
at the point of smallest beam diameter by locating the highest
with beams that have a diameter of
localized radiant power and averaging the radiant power
2 mm or less at any poin
...

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
---------------------- Page: 1 ----------------------
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
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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

6.2 Mesurages effectués pour classer les instruments dans les Groupe 1 ou 2 ............................ 20

6.3 Instruments du Groupe 2 : Mesures ....................................................................................................... 20

6.4 Détermination de la surface ..................................................................................................................... 21

6.5 Instruments du Groupe 2 : détermination du temps et du nombre d'impulsions

nécessaires pour atteindre l'exposition maximale recommandée ............................................ 21

7 Informations fournies par le fabricant ................................................................................................. 22

Annexe A (normative) Fonctions de pondération spectrale ...................................................................... 25

Annexe B (informative) Normes internationales de produits relatives aux instruments

ophtalmiques, y compris l'ISO 15004-2, contenant une section relative aux dangers

liés au rayonnement .................................................................................................................................... 31

Annexe C (informative) Instruments de mesure ............................................................................................ 32

Annexe D (normative) Méthodes de mesure de la luminance énergétique/de l'éclairement

énergétique ..................................................................................................................................................... 37

Annexe E (informative) Préconisations concernant le mesurage direct de l'éclairement

énergétique ..................................................................................................................................................... 42

Annexe F (informative) Logigramme de classification ................................................................................ 45

Annexe ZA (informative) Relation entre la présente Norme européenne et les exigences

essentielles de la Directive de l'UE 93/42/CEE .................................................................................. 46

Bibliographie ................................................................................................................................................................ 47

© ISO 2015 – Tous droits réservés
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ISO/FDIS 15004-2:2015(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 procédures utilisées pour élaborer le présent document et celles destinées à sa mise à jour sont

décrites dans les Directives ISO/CEI, Partie 1. Il convient, en particulier de prendre note des différents

critères d'approbation requis pour les différents types de documents ISO. Le présent document a été

rédigé conformément aux règles de rédaction données dans les Directives ISO/CEI, Partie 2

(voir www.iso.org/directives).

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. Les détails concernant les

références aux droits de propriété intellectuelle ou autres droits analogues identifiés lors de l'élaboration

du document sont indiqués dans l'Introduction et/ou sur la liste ISO des déclarations de brevets

reçues (voir www.iso.org/brevets).

Les éventuelles appellations commerciales utilisées dans le présent document sont données pour

information à l'intention des utilisateurs et ne constituent pas une approbation ou une recommandation.

Pour une explication de la signification des termes et expressions spécifiques de l'ISO liés à l'évaluation

de la conformité, aussi bien que pour des informations au sujet de l'adhésion de l'ISO aux principes de

l'OMC concernant les obstacles techniques au commerce (OTC) voir le lien suivant: Avant‐propos —

Informations supplémentaires.

Le comité chargé de l’élaboration du présent document est l’ISO/TC 172, Optique et photonique,

sous‐comité SC 7,Optique et instruments ophtalmiques.

Cette deuxième édition annule et remplace la première édition (ISO 15004‐2:2007), qui a fait l'objet

d'une révision technique.

L'ISO 15004 comprend les parties suivantes, présentées sous le titre général Instruments

ophtalmiques – Exigences fondamentales et méthodes d'essai :

— Partie 1 : Exigences générales applicables à tous les instruments ophtalmiques

— Partie 2 : Protection contre les dangers de la lumière
© ISO 2015 – Tous droits réservésits réservés
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PROJET FINAL DE NORME INTERNATIONALE ISO/FDIS 15004‐2:2015(F)
Instruments ophtalmiques — Exigences fondamentales et
méthodes d'essai — Partie 2: Protection contre les dangers de
la lumière
1 Domaine d'application

La présente partie de l'ISO 15004 spécifie les exigences fondamentales s'appliquant à la sécurité des instruments

ophtalmiques vis‐à‐vis des rayonnements optiques. La présente partie est applicable à tous les instruments

ophtalmiques qui dirigent le rayonnement optique dans ou vers l'œil et pour lesquels une section relative aux

exigences face aux dangers de la lumière figure dans les Normes internationales qui les concernent. Elle s'applique

également à tout futur ou nouvel instrument ophtalmique qui dirige le rayonnement optique dans ou vers l'œil,

ainsi qu'aux parties des systèmes thérapeutiques ou chirurgicaux qui dirigent le rayonnement optique dans ou vers

l'œil à des fins de diagnostic, d'éclairement, de mesurage, d'imagerie ou d'alignement.

La présente partie de l'ISO 15004 ne s'applique pas au rayonnement destiné au traitement des tissus oculaires.

NOTE 1 Dans le cas des faisceaux de traitement des dispositifs thérapeutiques, les limites données dans la

présente Norme internationale peuvent être appliquées au faisceau de traitement lors de la conduite d'évaluations

des risques pour les tissus non cibles.

Si des Normes internationales verticales (spécifiques aux instruments) contiennent des exigences spécifiques vis‐

à‐vis des dangers de la lumière différentes de celles données dans la présente partie de l'ISO 15004, celles indiquées

dans la Norme internationale verticale doivent avoir la priorité.

La présente partie de l'ISO 15004 classe les instruments ophtalmiques soit dans le Groupe 1, soit dans le Groupe 2,

afin de distinguer les instruments sans danger et ceux qui sont potentiellement dangereux.

NOTE 2 Les limites d'émission sont basées sur les lignes directrices de la Commission internationale en matière

de protection contre les rayonnements non ionisants (ICNIRP) en ce qui concerne l'exposition du corps humain aux

rayonnements optiques. Les limites et lignes directrices contenues dans la présente Norme internationale rendent

également compte des probabilités que les yeux puissent être dilatés et que les yeux et la tête puissent être stabilisés

pendant les examens ophtalmiques. Voir la référence [1]
2 Références normatives

Les documents ci‐après, dans leur intégralité ou non, sont des références normatives indispensables à

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 s'applique (y compris les éventuels

amendements).

ISO 15004‐1, Instruments ophtalmiques – Exigences fondamentales et méthodes d'essai ‐

Partie 1 : Exigences générales applicables à tous les instruments ophtalmiques
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ISO/FDIS 15004-2:2015(F)
3 Termes, définitions et symboles
3.1 Termes et définitions

Pour les besoins du présent document, les termes et définitions donnés dans l'ISO15004‐1 ainsi que les suivants

s'appliquent.
3.1.1
ouverture
diaphragme d'ouverture

élément qui définit la surface sur laquelle l’émission optique moyenne est mesurée

Note 1 à l’article : pour les mesurages de l'éclairement énergétique spectral, cette ouverture correspond souvent à

l'entrée d'une petite sphère placée devant la fente d'entrée du radiomètre/du spectroradiomètre.

3.1.2
source de rayonnement à ondes entretenues
source de rayonnement à OE

source de rayonnement fonctionnant à puissance continue pendant une durée pouvant être supérieure à

0,25 s (c'est‐à‐dire une source de rayonnement non pulsé) ou susceptible de le faire

3.1.3
instrument à dose limitée

dispositif ophtalmique, dont l'émission dépasse les limites de débit de dose (éclairement énergétique) du

Groupe 1, mais qui compte tenu de sa conception et de sa construction, ne peut pas exposer un œil donné

à un rayonnement qui atteint les limites d'exposition cumulée données en 6.5 et dans le Tableau 5 au

cours d'une période de 24 heures
Note 1 à l’article : cet instrument serait alors un instrument du Groupe 1.
3.1.4
ouverture effective
portion de l'ouverture qui limite la quantité de lumière éclairant la rétine

Note 1 à l’article : pour une ouverture cachée ou non circulaire, la zone de l'ouverture effective équivaut à celle

d'une ouverture circulaire non cachée.
3.1.5
endoilluminateur

dispositif constitué d'une source lumineuse et d'un câble de fibre optique lumineux, destiné à être inséré

dans l'œil en vue d'éclairer chaque partie de l'intérieur de l'œil
3.1.6
champ de vision

angle solide conique tel qu'il est « observé » par le détecteur, par exemple l'œil ou le

radiomètre/spectroradiomètre, par le biais duquel le détecteur reçoit des rayonnements

Note 1 à l’article : le champ de vision dénote l'angle sous lequel une moyenne de la luminance énergétique est

établie (échantillonnée) et il convient de ne pas le confondre avec l'angle sous‐tendu de la source α qui dénote la

taille de la source.
3.1.7
instrument du Groupe 1

instrument ophtalmique pour lequel il n'existe aucun danger potentiel lié au rayonnement et qui peut

être réputé conforme aux exigences définies en 5.2
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ISO/FDIS 15004-2:2015(F)
3.1.8
instrument du Groupe 2

instrument ophtalmique présentant un danger potentiel lié au rayonnement et qui ne satisfait pas aux

exigences définies en 5.2 mais qui satisfait à celles définies en 5.3
3.1.9
éclairement énergétique

(en un point d'une surface) rapport entre la puissance du rayonnement dΦ reçue sur un élément d'une

surface contenant ledit point et la zone dA de cet élément, c'est‐à‐dire

Note 1 à l’article : l'unité de l'éclairement énergétique est le watt par centimètre carré, W/cm2.

3.1.10
fabricant
personne physique ou morale qui commercialise l'instrument ophtalmique
3.1.11
intensité maximale

notion qui fait référence aux émissions de rayonnement optique maximales que l'instrument est

susceptible d'émettre dans toutes les conditions possibles
3.1.12
microscope chirurgical

microscope stéréoscopique utilisé pour l'observation de procédures chirurgicales ou d'autres procédures

médicales, constitué d'un dispositif d'éclairage et d'un système d'observation, y compris la lentille de

l'objectif, un système optique à puissance variable ou fixe, un tube d'observation et des oculaires

3.1.13
danger lié au rayonnement optique

risque de dommages pouvant être provoqués à l'œil suite à une exposition à une énergie rayonnante

optique
Note 1 à l’article : ultraviolet, visible ou infrarouge.
3.1.14
photorétinite

lésion rétinienne causée par une réaction photochimique et due à une exposition énergétique de la rétine

très intense

Note 1 à l’article : le terme maculopathie photique est également utilisé pour décrire une photorétinite dans la zone

fovéa‐maculaire de la rétine.
3.1.15
source lumineuse pulsée

source lumineuse qui délivre son énergie par exposition unique d'une durée connue de 0,25 s ou moins

ou par série d'impulsions, chaque impulsion ayant une durée inférieure à 0,25 s
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ISO/FDIS 15004-2:2015(F)

Note 1 à l’article : une source lumineuse émise par une série d'impulsions continues ou une énergie rayonnante

modulée où le pic de rayonnement est au moins égal à dix fois la puissance énergétique minimale est considérée

comme une source lumineuse pulsée.

Note 2 à l’article : la durée d'impulsion nominale, Δt, pour une évaluation des instruments à impulsions est

déterminée par l'intervalle de temps équivalent à la largeur totale de l'impulsion à la moitié du maximum de

l'impulsion. Le temps d'intégration de l'énergie, t, correspond à largeur d'impulsion totale pour une impulsion

unique et, pour des impulsions multiples, t correspond à la durée comprenant chaque impulsion et combinaison

d'impulsions.
3.1.16
luminance énergétique

(dans une direction et en un point donnés d'une surface réelle ou imaginaire) quantité définie par

l'équation
dA´´cos d

dΦ est la puissance du rayonnement transmise par un faisceau élémentaire passant par ledit point et

se propageant dans l'angle solide dΩ selon la direction donnée ;
dA est la surface d'une section de ce faisceau contenant le point donné ;
θ est l'angle entre la normale à cette section et la direction du faisceau

Note 1 à l’article : la même définition s'applique à la luminance énergétique intégrée dans le temps Li si, dans

l'équation pour L, la puissance de rayonnement dΦ est remplacée par l'énergie rayonnante dQ.

Note 2 à l’article : l'unité de luminance énergétique est le watt par stéradian centimètre carré, W/(sr⋅cm2) ; l'unité

de luminance énergétique intégrée dans le temps est le joule par stéradian centimètre carré, J/(sr⋅cm2).

3.1.17
exposition énergétique

(en un point d'une surface, pour une période donnée) rapport entre l'énergie rayonnante, dQ,, reçue par

un élément d'une surface contenant ledit point sur la durée donnée et l'unité d'aire dA de cet élément

Note 1 à l’article : de même, l'exposition énergétique est définie comme l'intégrale de l'éclairement énergétique, E,

en un point et sur une durée donnés, Δt
HE=´dt

Note 2 à l’article : l'unité d'exposition énergétique est le joule par centimètre carré, J/cm2.

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ISO/FDIS 15004-2:2015(F)
3.1.18
instrument à balayage

instrument émettant un rayonnement caractérisé par une direction, une origine ou un mode de

propagation variant dans le temps par rapport à un cadre de référence fixe
3.1.19
éclairement énergétique spectral

rapport entre la puissance spectrale du rayonnement dΦ (λ) sur un intervalle de longueur d'onde dλ,

reçue par un élément d'une surface et le produit de l'aire dA de cet élément de l'intervalle de longueur

d'onde dλ
d 
E =
dA´ d

Note 1 à l’article : l'unité de l'éclairement énergétique spectral est le watt par centimètre carré par nanomètre,

W/(cm2.nm).
3.1.20
luminance énergétique spectrale

(pour un intervalle de longueur d'onde dλ, dans une direction et en un point donnés) rapport entre la

puissance spectrale du rayonnement dΦ (λ) passant par ce point et se propageant dans l'angle solide dΩ

dans la direction donnée et le produit de l'intervalle de longueur d'onde dλ et des aires d'une section de

ce faisceau sur un plan perpendiculaire à la direction (cos θ dA) contenant le point et à l'angle solide dΩ

d
L =
dA´´cos d´d

Note 1 à l’article : l'unité de la luminance énergétique spectrale est le watt par stéradian centimètre carré par

nanomètre, W/(sr·cm2.nm).
3.1.21
instrument à durée limitée
dispositif ophtalmique dont la durée maximale d'exposition est limitée et connue
3.2 Symboles
Les symboles, grandeurs et unités sont répertoriés dans le Tableau 1.
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ISO/FDIS 15004-2:2015(F)
Tableau 1 — Symboles, grandeurs et unités (1 sur 2)
Symbole Quantité Unité
E éclairement énergétique (en un point d'une surface) W/cm2
Eλ éclairement énergétique spectral W/(cm2⋅nm)

L luminance énergétique (dans une direction et en un point donnés d'une surface W/(sr⋅cm2)

réelle ou imaginaire)

Lλ luminance énergétique spectrale (pour un intervalle de longueur d'onde dλ, dans W/(sr·cm2.nm)

une direction et en un point donnés)
Li luminance énergétique intégrée dans le temps J/(sr⋅cm2)

H exposition énergétique (en un point d'une surface, pour une durée donnée) J/cm2

Hλ exposition énergétique spectrale J/(cm2⋅nm)

ES‐CL éclairement énergétique pondéré S(λ) de la cornée et du cristallin par un W/cm2

rayonnement ultraviolet

EUV‐CL éclairement énergétique non pondéré de la cornée et du cristallin par un W/cm2

rayonnement ultraviolet
EA‐R éclairement énergétique pondéré A(λ) de la rétine W/cm2

EIR‐CL éclairement énergétique non pondéré de la cornée et du cristallin par un W/cm2

rayonnement infrarouge

EVIR‐AS éclairement énergétique non pondéré du segment antérieur par un rayonnement W/cm2

infrarouge et visible

EVIR‐R éclairement énergétique thermique pondéré R(λ) de la rétine par un rayonnement W/cm2

infrarouge et visible
LA‐R luminance énergétique pondérée A(λ) de la rétine W/(sr⋅cm2)

Li,A‐R luminance énergétique intégrée dans le temps pondérée A(λ) de la rétine J/(sr⋅cm2)

Li,VIR‐R luminance énergétique intégrée dans le temps pondérée R(λ) de la rétine à un J/(sr⋅cm2)

rayonnement infrarouge et visible

LVIR‐R luminance énergétique pondérée R(λ) de la rétine à un rayonnement infrarouge et W/(sr⋅cm2)

visible

HVIR‐R exposition énergétique pondérée R(λ) de la rétine à un rayonnement infrarouge et J/cm2

visible

HIR‐CL exposition énergétique non pondérée de la cornée et du cristallin à un rayonnement J/cm2

infrarouge

HVIR‐AS exposition énergétique non pondérée du segment antérieur à un rayonnement J/cm2

infrarouge et visible

HS‐CL exposition énergétique pondérée S(λ) de la cornée et du cristallin à un rayonnement J/cm2

ultraviolet

HUV‐CL exposition énergétique non pondérée de la cornée et du cristallin à un rayonnement J/cm2

ultraviolet
HA‐R exposition énergétique pondérée A(λ) de la rétine J/cm2

S(λ) fonction de pondération du danger du rayonnement ultraviolet (voir Annexe A) —

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ISO/FDIS 15004-2:2015(F)
Tableau 1 (2 sur 2)
Symbole Quantité Unité

A(λ) fonction de pondération du danger photochimique en cas d'aphakie (voir Annexe A) —

B(λ) fonction des dangers liés à la lumière bleue (voir Annexe A) —

R(λ) fonction de pondération du danger thermique du rayonnement infrarouge et visible —

(voir Annexe A)
Δλ intervalle de somme nm
temps d'exposition, également :
temps d'intégration de l'énergie ;
pour les instruments à impulsions : correspond au temps nécessaire pour délivrer
t s
une largeur d'impulsion totale pour une impulsion unique et, pour des impulsions
multiples, t correspond à la durée comprenant chaque impulsion et combinaison
d'impulsions
Δt largeur d'impulsion jusqu'à une durée de 0,25 s s
Eλ·t exposition énergétique spectrale J/(cm2.nm)
(Eλ·Δt) exposition énergétique spectrale au temps Δt J/(cm2.nm)
vs vitesse de balayage du faisceau sur la surface de tissu irradiée mm/s
4 Classification

Pour les besoins de la présente partie de l'ISO 15004, les instruments ophtalmiques sont classés en deux groupes,

afin de séparer les instruments pouvant présenter un danger potentiel de ceux qui n'en présentent aucun. Les deux

groupes sont appelés Groupe 1 et Groupe 2. Ils sont définis comme suit :

a) Instruments du Groupe 1 : instruments ophtalmiques ne présentant aucun danger potentiel lié au

rayonnement. Instruments ophtalmiques pouvant être présentés comme satisfaisant aux exigences

définies en 5.2.

b) Instruments du Groupe 2 : instruments ophtalmiques présentant un danger potentiel lié au

rayonnement. Instruments ophtalmiques ne satisfaisant pas aux exigences définies en 5.2 mais

satisfaisant à celles du 5.3.

NOTE Le processus de classification est décrit dans le logigramme de classification (voir Annexe F).

5 Exigences
5.1 Généralités

Les instruments ophtalmiques doivent être conçus de telle sorte que l'énergie soit atténuée autant que possible

pour toutes les longueurs d'onde, tout en conservant l'usage prévu de l'instrument.

Dans le cas où un instrument ophtalmique est utilisé en association avec un autre dispositif, le système de liaison

ne doit pas dégrader la sécurité de l'un ou de l'autre des instruments vis‐à‐vis du rayonnement optique. En outre,

les dangers liés au rayonnement optique du système combiné ne doivent pas dépasser les niveaux donnés dans la

présente partie de l'ISO 15004.
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ISO/FDIS 15004-2:2015(F)
5.2 Exigences de classification en tant qu'instrument du Groupe 1
5.2.1 Généralités

Un instrument ophtalmique doit être classé dans le Groupe 1 si tout ou partie des critères suivants s'appliquent.

a) Une Norme internationale est consacrée au type d'instrument, mais aucune exigence applicable aux

dangers liés au rayonnement n'est incluse dans cette Norme internationale.

b) Ses composants tels que les lampes, les diodes électroluminescentes, les filtres non amovibles, les

lentilles, les fibres optiques, etc., empêchent les émissions dépassant les limites spécifiées pour les

instruments du Groupe 1 et des certifications de ces composants existent. Ces instruments doivent

être classés dans le Groupe 1, en raison de la certification de l'essai, par le fabricant des composants

sans qu'aucun mesurage supplémentaire soit nécessaire. Si ces composants empêchent seulement

certaines (et non pas toutes) les émissions de dépasser les limites spécifiées pour le Groupe 1, alors

les mesurages doivent être effectués uniquement pour les paramètres figurant dans les Tableaux 2

et 3 si les composants n'empêchent pas de dépasser les limites.

c) Ses valeurs d'émission sont inférieures ou égales aux valeurs limites données en 5.4. Les méthodes

d'essai utilisées pour la détermination de la conformité doivent être conformes aux exigences

définies en 6.2.

d) Il s'agit d'un instrument à dose limitée en vertu de sa construction et de sa conception, telles que

définies en 3.1.3.

Les Normes internationales existantes qui comportent des exigences vis‐à‐vis des dangers de la lumière sont

énumérées à l'Annexe B. Les valeurs limites permettant de déterminer la classification du Groupe 1 sont basées sur

un temps d'exposition prévu pour le type d'instrument étudié. Les valeurs limites du Groupe 1, données en 5.4,

s'appuient sur un temps d'exposition de 1 h. Ces limites s'appliquent à tous les instruments à l'exception des

microscopes chirurgicaux, des endoilluminateurs et des instruments conçus pour une exposition continue. Pour les

instruments conçus pour une exposition continue, il convient de restreindre les limites par un facteur équivalent à

la moitié du temps d'exposition continue, exprimé en heures, associé à l'usage prévu de l'instrument.

Les instruments à durée limitée satisfont à l'exigence du Groupe 1 vis‐à‐vis du danger lié au rayonnement

photochimique sur la rétine en cas d'aphakie, EA‐R, si leur temps maximal d'exposition est inférieur à la durée

nécessaire pour atteindre l'exposition maximale recommandée pour l'exposition photochimique de la rétine en cas

d'aphakie, tmax, conformément au 6.5.3.

5.2.2 Exigences pour la classification d'un instrument à balayage en tant qu'instrument du

Groupe 1

Un instrument ophtalmique qui donne une image de la rétine ou du segment antérieur de l'œil en utilisant une petite

surface irradiée mobile doit être classé en tant qu'instrument du Groupe 1 pour le danger thermique pour la rétine

lié au rayonnement infrarouge et visible si l'énergie d'irradiation totale entrant dans l'œil crée un éclairement

énergétique thermique pondéré de la rétine par un rayonnement infrarouge et visible inférieur ou égal

...

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