SIST EN ISO 15004:2000
(Main)Ophthalmic instruments - Fundamental requirements and test methods (ISO 15004:1997)
Ophthalmic instruments - Fundamental requirements and test methods (ISO 15004:1997)
This International Standard specifies Fundamental requirements for non-invasive, active and non-active ophthalmic instruments. This International Standard is also applicable to low-vision aids and tonometers, but not to other ophthalmic instruments which are used in contact with the globe of the eyes. This International Standard takes precedence over the corresponding requirements of the other general standards cited in clause 2, if differences exist. This International Standard does not apply to operation microscopes, endoscopes and devices intended for laser investigation or laser treatment of the eye.
Ophthalmische Instrumente - Grundlegende Anforderungen und Prüfverfahren (ISO 15004:1997)
Diese Internationale Norm legt Anforderungen für nichtinvasive aktive und nichtaktive ophthalmische Instrumente fest. Diese Internationale Norm gilt für Sehhilfen für Schwachsichtige und Tonometer. Sie gilt nicht für andere ophthalmische Instrumente, die im Kontakt mit dem Augapfel benutzt werden. Sofern Unterschiede bestehen, hat diese Internationale Norm Vorrang vor den entsprechenden Anforderungen in den anderen allgemeinen Normen, die in Abschnitt 2 aufgeführt sind.
Instruments ophtalmiques - Exigences fondamentales et méthodes d'essai (ISO 15004:1997)
Oftalmični instrumenti - Temeljne zahteve in preskusne metode (ISO 15004:1997)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 15004:2000
01-januar-2000
2IWDOPLþQLLQVWUXPHQWL7HPHOMQH]DKWHYHLQSUHVNXVQHPHWRGH ,62
Ophthalmic instruments - Fundamental requirements and test methods (ISO
15004:1997)
Ophthalmische Instrumente - Grundlegende Anforderungen und Prüfverfahren (ISO
15004:1997)
Instruments ophtalmiques - Exigences fondamentales et méthodes d'essai (ISO
15004:1997)
Ta slovenski standard je istoveten z: EN ISO 15004:1997
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 15004:2000 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 15004:2000
INTERNATIONAL ISO
STANDARD 15004
First edition
1997-12-15
Ophthalmic instruments — Fundamental
requirements and test methods
Instruments ophtalmiques — Exigences fondamentales et méthodes d’essai
A
Reference number
ISO 15004:1997(E)
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SIST EN ISO 15004:2000
ISO 15004:1997(E)
Contents
1 Scope .1
2 Normative references .1
3 Definitions .1
4 Fundamental requirements (for non-active and active ophthalmic instruments).2
5 Environmental conditions (for non-active and active ophthalmic instruments).3
6 Particular requirements for active ophthalmic instruments.5
7 Test methods.6
8 Information supplied by the manufacturer.10
Annex A (normative) Optical radiation hazard. 11
Annex B (normative) Product-related International Standards for ophthalmic instruments .13
Annex C (informative) Photometric quantities .14
Annex D (informative) Example of information on the avoidance of overexposure
to potentially hazardous optical radiation.16
© ISO 1997
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic
or mechanical, including photocopying and microfilm, without permission in writing from the publisher.
International Organization for Standardization
Case postale 56 • CH-1211 Genève 20 • Switzerland
Internet central@iso.ch
X.400 c=ch; a=400net; p=iso; o=isocs; s=central
Printed in Switzerland
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SIST EN ISO 15004:2000
© ISO
ISO 15004:1997(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.
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.
International Standard ISO 15004 was prepared by ISO/TC 172, Optics and optical instruments, Subcommittee
SC 7, Ophthalmic optics and instruments.
Annexes A and B form an integral part of this International Standard. Annexes C and D are for information only.
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SIST EN ISO 15004:2000
©
INTERNATIONAL STANDARD ISO ISO 15004:1997(E)
Ophthalmic instruments – Fundamental requirements and test
methods
1 Scope
This International Standard specifies Fundamental requirements for non-invasive, active and non-active ophthalmic
instruments. This International Standard is also applicable to low-vision aids and tonometers, but not to other
ophthalmic instruments which are used in contact with the globe of the eye.
This International Standard takes precedence over the corresponding requirements of the other general standards
cited in clause 2, if differences exist.
This International Standard does not apply to operation microscopes, endoscopes and devices intended for laser
investigation or laser treatment of the eye.
2 Normative references
The following standards contain provisions which, through reference in this text, constitute provisions of this
International Standard. At the time of publication, the editions indicated were valid. All standards are subject to
revision, and parties to agreements based on this International Standard are encouraged to investigate the
possibility of applying the most recent editions of the standards indicated below. Members of IEC and ISO maintain
registers of currently valid International Standards.
ISO 9022-2:1994, Optics and optical instruments — Environmental test methods — Part 2: Cold, heat, humidity.
ISO 9022-3:1994, Optics and optical instruments — Environmental test methods — Part 3: Mechanical stress.
IEC 60601-1:1988, Medical electrical equipment — Part 1: General requirements for safety.
IEC 60601-1-1:1992, Medical electrical equipment — Part 1: General requirements for safety. 1. Collateral
standard: Safety requirements for medical electrical systems.
3 Definitions
For the purposes of this International Standard, the following definitions apply.
3.1 non-invasive ophthalmic instrument
Ophthalmic instrument which does not in whole or in part penetrate inside the body, either through a body orifice or
through the surface of the body.
3.2 active ophthalmic instrument
Any ophthalmic instrument connected with a permanently installed source of electrical power energy.
3.3 manufacturer (of an ophthalmic instrument)
Natural or legal person who places the ophthalmic instrument on the market.
3.4 optical radiation hazard
Possibility of damage to the retina by optical radiation.
NOTE — The effect of the radiance of a source (see 3.6) will decrease as the light beam passes through an optical system
due to filtering, absorption or other loss mechanisms. Thus, basing the optical radiation hazard on the source radiance ensures
that the radiance at the retina cannot exceed the source radiance.
1
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3.5 irradiance, E
Radiant flux dF incident on an element of a surface of unit area dA.
NOTE — Irradiance is expressed in milliwatts per square centimetre (mW/cm²).
3.6 radiance, L
In a given direction at a given point, the quotient of the radiant flux dΦ passing through that point and propagating
within the solid angle dW in a direction q divided by the product of the area of a section of that beam on a plane
perpendicular to this direction containing the given point and the solid angle dW (see C.1).
NOTE Radiance is expressed in milliwatts per square centimetre per steradian [mW/(cm² · sr)].
3.7 spectral radiance, L (l)
l
Value of the radiance (see 3.6) of an infinitesimal wavelength interval, at any given wavelength in the spectrum, divided by the
range of that interval.
NOTE Spectral radiance is expressed in milliwatts per square centimetre per steradian per nanometer [mW/(cm² · sr · nm)].
3.8 spectrally weighted photochemical aphakic source radiance, L
A
Spectral radiance of the source integrated over the aphakic spectrum range 305 nm to 700 nm and weighted by
A(l) as given by the equation:
700
LL=�llA�Dl
() ()
A
�l
. . . (1)
305
where A(l) is the spectral weighting function for the aphakic retinal hazard analysis (see annex A).
3.9 spectrally weighted photochemical phakic source radiance, L
B
Spectral radiance of the source integrated over the phakic spectrum range 380 nm to 700 nm and weighted by B(λ)
as given by the equation:
700
LL=�()llB()�Dl
B�l
. . . (2)
380
where B(l) is the spectral weighting function for the phakic retinal hazard analysis (see annex A).
4 Fundamental requirements (for non-active and active ophthalmic instruments)
4.1 Design
Ophthalmic instruments shall be so designed that, when used for the performance of the intended function(s) in
accordance with instructions provided by the manufacturer, the risks associated with such use are reduced to a
level compatible with the generally acknowledged state of the art.
4.2 Performance
The ophthalmic instrument shall achieve the performance stipulated by the manufacturer for the intended function(s)
under the intended conditions of use.
In addition to the requirements of this International Standard, the supplementary or modified requirements specified
in the relevant product-related International Standards listed in annex B apply.
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4.3 Combination of different devices
If another device is intended for use in combination with an ophthalmic instrument, the connecting system shall not
impair the specified performance of either instrument.
For coupling with active ophthalmic instruments, the provisions of IEC 60601-1-1shall apply.
4.4 Materials
4.4.1 Components of the ophthalmic instrument which are designed to come into direct contact with the skin of the
patient or operator shall be made of materials which are neither toxic nor known to create significant allergic
reactions, when used as intended by the manufacturer.
4.4.2 Materials used shall not ignite. When tested as described in 7.1, combustion shall not continue after
withdrawal of the test rod.
4.5 Protection against contaminants
Parts of the ophthalmic instrument which are designed to come into contact with the patient or the operator shall
either be capable of easy disinfection or be protected by a disposable cover.
4.6 Scales and displays
Scales and displays for readout of ophthalmic instruments shall be designed and placed in accordance with
ergonomic principles, taking into account the intended purpose of the instrument.
4.7 Thermal hazards
The temperature of parts of the ophthalmic instrument held by the operator or accessible to the patient shall not
exceed the allowable maximum temperatures given in table Xa of IEC 60601-1:1988, clause 42.1.
4.8 Mechanical hazards
The ophthalmic instrument shall be designed so that, when used to perform the intended function(s) in conformance
with the user instructions, the risk of physical injury when using this instrument is reduced as much as is practicable.
5 Environmental conditions (for non-active and active ophthalmic instruments)
NOTE The requirements specified in 5.1, 5.2 and 5.3 are verified as described in 7.3.
5.1 Environmental conditions of use
The ophthalmic instrument shall conform to all safety, optical, mechanical and accuracy requirements under the
environmental conditions given in table 1.
5.2 Storage conditions
After being stored under the conditions given in table 2, the ophthalmic instrument shall conform to all safety,
optical, mechanical and accuracy requirements under the environmental conditions of use given in table 1 after
being fully adapted to these conditions.
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Table 1 — Environmental conditions of use
Criterion Environmental condition
Temperature + 10°C to + 35°C
Relative humidity 30 % to 75 %
Atmospheric pressure 800 hPa to 1060 hPa
Shock (without packing) *) 10 g duration 6 ms
*) Applicable to hand-held instruments only.
Table 2 — Storage conditions
Criterion Environmental condition
Temperature
- 10°C to + 55°C
Relative humidity 10 % to 95 %
Atmospheric pressure 700 hPa to 1060 hPa
5.3 Resistance to transport conditions
NOTE It is recommended that the instrument in its original packaging be tested for ability to withstand transport conditions.
If ability to withstand exposure to the transport conditions listed in table 3 of this International Standard is claimed
[see 8.1 c)], the following shall apply:
After exposure of the ophthalmic instrument in its original packing to the range of transport conditions given in table
3, the ophthalmic instrument shall conform to all safety, optical, mechanical and accuracy requirements under the
environmental conditions of use given in table 1 after being fully adapted to these conditions.
Table 3 — Transport conditions
Criterion Transport conditions
Temperature
- 40°C to + 70°C
Relative humidity 10 % to 95 %
Atmospheric pressure 500 hPa to 1060 hPa
Sinusoidal vibration 10 Hz to 500 Hz: 0,5 g
Shock 30 g, duration 6 ms
Bump 10 g, duration 6 ms
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6 Particular requirements for active ophthalmic instruments
6.1 Electrical safety
With respect to electrical safety, IEC 60601-1shall apply.
Compliance with the requirements shall be verified as described in 7.4.
6.2 Inapplicable clauses of IEC 60601-1:1988
The requirements on mechanical strength as specified in clause 21.6 of IEC 60601-1:1988 shall not apply.
6.3 Optical radiation hazard
6.3.1 General
NOTE — This clause replaces clauses 32, 33 and 34 of IEC 60601-1:1988.
The possibility of an optical radiation hazard will be present only for those types of ophthalmic instruments with very
high level of radiation output which is capable of causing high irradiance on the retina. The limiting values given in
6.3.2 are considered acceptable with respect to the risks when weighted against the performances intended.
Where appropriate, each specific instrument standard expressly states that the requirements given in 6.3.2 to 6.3.4
shall apply.
6.3.2 Limiting values
The limiting values given in items a) and b) shall apply to the radiation from the ophthalmic instrument used to
illuminate, view or photograph the human eye with light from 380 nm to 700 nm and in which the full beam
homogeneously illuminates a circular pupil of diameter 8 mm (see notes 1 to 6).
a) Short wavelength limit: The amount of radiant power exiting the instrument in the portion of the spectrum from
305 nm to 400 nm shall have an irradiance no greater than 0,05 mW/cm² as measured in the corneal plane
1
when the instrument is operating at maximum intensity and, if the aperture can be varied, at maximum
aperture.
b) Long wavelength limit: The amount of energy exiting the instrument in the wavelength range 700 nm to 1100
nm shall not exceed 100 mW/cm², nor shall it exceed the amount of energy exiting the instrument in the range
between 380 nm and 700 nm. The energy shall be measured in the corneal plane when the instrument is
1
operating at maximum intensity and maximum aperture.
NOTES
1 If due to stops or other obstructions of the beam, a circular area of less than 8 mm diameter is illuminated, the limiting
values may be increased by the ratio of the area of an 8 mm diameter pupil to the true area illuminated.
2 It is recommended that the energy in the range of the spectrum below 420 nm be attenuated as much as possible.
3 For instruments with a large illuminating solid angle Ω over the designated spectral range 305 nm to 400 nm, i.e.Ω > 0,031
sr, the limiting values may be increased by the ratio of the true solid angle, expressed in steradians, divided by 0,031 (e.g. valid
for instruments such as fundus cameras).
4 For instruments with a small illuminating solid angle over the designated spectral range 305 nm to 400 nm, i.e. << 0,031
Ω Ω
sr, the limiting value of illumination is given by the radiance L = 1,6 mW/(cm² · sr) instead of an irradiance value in the corneal
plane (e.g. valid for instruments like retinoscopes).
5 For instruments with non-pulsed radiation, the assumptions used to set the limiting value for radiation shorter in wavelength
than 400 nm are based on considerations of the typical spectral distribution of a 3000 K standard black-body source, an
illuminating solid angle at the corneal plane of 0,031 sr, a maximum exposure time of 5 min and the weighting factors for L
A
(see annex A). The limit is set to ensure
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