SIST EN ISO 15004-2:2007
(Main)Ophthalmic instruments - Fundamental requirements and test methods - Part 2: Light hazard protection (ISO 15004-2:2007)
Ophthalmic instruments - Fundamental requirements and test methods - Part 2: Light hazard protection (ISO 15004-2:2007)
This part of ISO 15004 specifies fundamental requirements for optical radiation safety for ophthalmic instruments and is applicable to all ophthalmic instruments that direct optical radiation into or at the eye and for which there is a specific light hazards requirement section within their respective International Standards, i.e. all ophthalmic instruments listed in Annex B. It is also applicable to all new and emerging ophthalmic instruments that direct optical radiation into or at the eye. Where differences exist between this part of ISO 15004 and the light hazard requirements section of the respective vertical International Standard, then the vertical International Standard shall take precedence.
Ophthalmische Instrumente - Grundlegende Anforderungen und Prüfverfahren - Teil 2: Schutz gegen Gefährdung durch Licht (ISO 15004-2:2007)
Der vorliegende Teil von ISO 15004 legt grundlegende Anforderungen an optische Strahlungssicherheit für ophthalmische Instrumente fest und gilt für alle ophthalmischen Instrumente, die optische Strahlung in oder auf das Auge richten und für die in den entsprechenden Internationalen Normen besondere Abschnitte zu Anforderungen hinsichtlich einer Gefährdung durch Licht enthalten sind, d. h. alle in Anhang B aufgeführten ophthalmischen Instrumente. Dieser Teil der Norm gilt ebenfalls für alle neuen und in der Entwicklung be¬find¬lichen ophthalmischen Instrumente, die optische Strahlung in oder auf das Auge richten. Sollten in Bezug auf eine Gefährdung durch Licht zwischen den Festlegungen von diesem Teil von ISO 15004 und den An¬for¬de¬run¬gen einer produktbezogenen Inter¬nationalen Norm Unterschiede bestehen, so haben die betreffenden Fest¬legungen der produktbezogenen Internationalen Norm Vorrang.
ANMERKUNG Die Emissionsgrenzen beruhen auf den von der International Commission on Non Ionizing Radiation Protection (ICNIRP) (Internationale Kommission zum Schutz vor nichtionisierender Strahlung) festgelegten Richtlinien für die Einwirkung optischer Strahlung auf den Menschen. Siehe Literaturhinweis [1].
Dieser Teil von ISO 15004 gilt nicht für Instrumente, deren Strahlung die in ISO 15004 fest¬ge¬legten Grenz¬werte überschreitet und für die Augenbehandlung vorgesehen sind.
Im vorliegenden Teil von ISO 15004 werden ophthalmische Instrumente zur Unterscheidung zwischen un¬ge¬fähr¬lichen und möglicherweise gefährlichen Instrumenten entweder der Gruppe 1 oder Gruppe 2 zugeordnet.
Instruments ophtalmiques - Exigences fondamentales et méthodes d'essai - Partie 2: Protection contre les dangers de la lumiere (ISO 15004-2:2007)
L'ISO 15004-2:2007 spécifie les exigences fondamentales s'appliquant à la sécurité des instruments ophtalmiques vis-à-vis des rayonnements optiques et est applicable à tous les instruments ophtalmiques qui dirigent le rayonnement optique dans ou vers l'oeil 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'oeil.
L'ISO 15004-2:2007 ne s'applique pas aux rayonnements qui n'entrent pas dans le cadre des limites spécifiées dans la présente Norme internationale et qui sont destinées au traitement de l'oeil.
L'ISO 15004-2:2007 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.
Oftalmični instrumenti - Osnovne zahteve in preskusne metode - 2. del: Zaščita pred nevarno svetlobo (ISO 15004-2:2007)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 15004-2:2007
01-julij-2007
1DGRPHãþD
SIST EN ISO 15004:2000
2IWDOPLþQLLQVWUXPHQWL2VQRYQH]DKWHYHLQSUHVNXVQHPHWRGHGHO =DãþLWD
SUHGQHYDUQRVYHWORER ,62
Ophthalmic instruments - Fundamental requirements and test methods - Part 2: Light
hazard protection (ISO 15004-2:2007)
Ophthalmische Instrumente - Grundlegende Anforderungen und Prüfverfahren - Teil 2:
Schutz gegen Gefährdung durch Licht (ISO 15004-2:2007)
Instruments ophtalmiques - Exigences fondamentales et méthodes d'essai - Partie 2:
Protection contre les dangers de la lumiere (ISO 15004-2:2007)
Ta slovenski standard je istoveten z: EN ISO 15004-2:2007
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 15004-2:2007 en;fr;de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
EUROPEAN STANDARD
EN ISO 15004-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
February 2007
ICS 11.040.70 Supersedes EN ISO 15004:1997
English Version
Ophthalmic instruments - Fundamental requirements and test
methods - Part 2: Light hazard protection (ISO 15004-2:2007)
Instruments ophtalmiques - Exigences fondamentales et Ophthalmische Instrumente - Grundlegende Anforderungen
méthodes d'essai - Partie 2: Protection contre les dangers und Prüfverfahren - Teil 2: Schutz gegen Gefährdung durch
de la lumière (ISO 15004-2:2007) Licht (ISO 15004-2:2007)
This European Standard was approved by CEN on 10 February 2007.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2007 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15004-2:2007: E
worldwide for CEN national Members.
---------------------- Page: 2 ----------------------
EN ISO 15004-2:2007 (E)
Foreword
This document (EN ISO 15004-2:2007) has been prepared by Technical Committee ISO/TC 172
"Optics and optical instruments" in collaboration with Technical Committee CEN/TC 170 "Ophthalmic
optics", the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of
an identical text or by endorsement, at the latest by August 2007, and conflicting national
standards shall be withdrawn at the latest by August 2007.
This document supersedes EN ISO 15004:1997.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium,
Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United
Kingdom.
Endorsement notice
The text of ISO 15004-2:2007 has been approved by CEN as EN ISO 15004-2:2007 without any
modifications.
2
---------------------- Page: 3 ----------------------
INTERNATIONAL ISO
STANDARD 15004-2
First edition
2007-02-15
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
Reference number
ISO 15004-2:2007(E)
©
ISO 2007
---------------------- Page: 4 ----------------------
ISO 15004-2:2007(E)
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but
shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In
the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
© ISO 2007
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2007 – All rights reserved
---------------------- Page: 5 ----------------------
ISO 15004-2:2007(E)
Contents Page
Foreword. iv
1 Scope . 1
2 Normative references . 1
3 Terms, definitions and symbols. 1
3.1 Terms and definitions. 1
3.2 Symbols . 5
4 Classification. 6
5 Requirements . 6
5.1 General. 6
5.2 Requirements for classification as a Group 1 instrument. 6
5.3 Requirements for Group 2 instruments. 7
5.4 Emission limits for determination of Group 1 classification . 7
5.5 Emission limits and guideline values for Group 2 instruments . 11
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 maximum
exposure guidelines . 17
7 Information supplied by the manufacturer . 18
Annex A (normative) Spectral weighting functions. 20
Annex B (informative) Product-related International Standards for ophthalmic instruments to
which ISO 15004-2 applies and which contain a specific light hazard section. 26
Annex C (informative) Measurement instruments . 27
Annex D (normative) Measurement methods for radiance/irradiance. 28
Annex E (informative) Guidance on the direct measurement of irradiance . 33
Annex F (informative) Classification flowchart . 35
Bibliography . 37
© ISO 2007 – All rights reserved iii
---------------------- Page: 6 ----------------------
ISO 15004-2:2007(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 15004-2 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 7,
Ophthalmic optics and instruments.
This first edition, together with ISO 15004-1, cancels and replaces ISO 15004:1997. All reference to light
hazard (definitions 3.4 to 3.9, subclause 6.3, subclause 7.5, Annexes A, C and D of ISO 15004:1997) has
essentially been moved to the present part of ISO 15004 and 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 2007 – All rights reserved
---------------------- Page: 7 ----------------------
INTERNATIONAL STANDARD ISO 15004-2:2007(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 is applicable to all ophthalmic instruments that direct optical radiation into or at the eye and
for which there is a specific light hazards requirement section within their respective International Standards,
i.e. all ophthalmic instruments listed in Annex B. It is also applicable to all new and emerging ophthalmic
instruments that direct optical radiation into or at the eye. Where differences exist between this part of
ISO 15004 and the light hazard requirements section of the respective vertical International Standard, then the
vertical International Standard shall take precedence.
NOTE The emission limits are based on the International Commission on Non-Ionizing Radiation Protection (ICNIRP)
guidelines for human exposure to optical radiation. See Bibliography [1].
This part of ISO 15004 does not apply to radiation that is in excess of limits specified in ISO 15004 and that is
intended for treatment of the eye.
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.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
IEC 60825-1:2001, Safety of laser products — Part 1: Equipment classification, requirements and user’s guide
3 Terms, definitions and symbols
3.1 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1.1
aperture
aperture stop
opening that defines the area over which average optical emission is measured
NOTE For spectral irradiance measurements this opening is usually the entrance of a small sphere placed in front of
the radiometer/spectroradiometer entrance slit.
© ISO 2007 – All rights reserved 1
---------------------- Page: 8 ----------------------
ISO 15004-2:2007(E)
3.1.2
continuous wave radiation source
CW radiation source
radiation source that is operated with a continuous output for a time greater than 0,25 s (i.e. a non-pulsed
radiation source)
3.1.3
effective aperture
portion of the aperture that limits the amount of light delivered to the retina
NOTE For an obscured or noncircular aperture, it has an area equivalent to that of a non-obscured circular aperture.
3.1.4
emission limit
maximum value of optical radiation output allowed
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 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
3.1.9
irradiance
E
〈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.
dΦ
E = (1)
dA
2
NOTE 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
2 © ISO 2007 – All rights reserved
---------------------- Page: 9 ----------------------
ISO 15004-2:2007(E)
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
3.1.14
photoretinitis
retinal photochemically-induced injury resulting from a very intense retinal radiant exposure
NOTE 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 pulse or a train of pulses where each pulse has a
duration of less than 0,25 s
NOTE 1 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 The pulse duration is the interval of time between the first and last instants at which the instantaneous value of
a pulse reaches a specified fraction of its pulse magnitude or a specified threshold.
3.1.16
radiance
L
〈in a given direction at a given point of a real or imaginary surface〉 quantity defined by the formula
dΦ
L = (2)
dcA××osθ 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 The same definition holds for the time-integrated radiance L if, in the equation for L, the radiant power dΦ is
i
replaced by the radiant energy dQ.
2
NOTE 2 Radiance is expressed in watts per steradian square centimetre, W/(sr⋅cm ); time-integrated radiance is
2
expressed in Joules per steradian square centimetre, J/(sr⋅cm ).
3.1.17
radiant exposure
H
〈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
dQ
H = (3)
dA
© ISO 2007 – All rights reserved 3
---------------------- Page: 10 ----------------------
ISO 15004-2:2007(E)
Equivalently, the radiant exposure is defined as the integral of the irradiance, E, at a given point over a given
duration, ∆t
H=×Etd (4)
∫
∆t
2
NOTE Radiant exposure is expressed in Joules per square centimetre, J/cm .
3.1.18
scanning laser radiation
laser radiation having a time-varying direction, origin or pattern of propagation with respect to a stationary
frame of reference
3.1.19
spectral irradiance
E
λ
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 = (5)
λ
ddA× λ
2.
NOTE Spectral irradiance is expressed in watts per square centimetre nanometre, W/(cm nm).
3.1.20
spectral radiance
L
λ
〈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 = (6)
λ
dcA××osθ dΩλ×d
. 2.
NOTE Spectral radiance is expressed in watts per steradian square centimetre nanometre, W/(sr cm nm).
4 © ISO 2007 – All rights reserved
---------------------- Page: 11 ----------------------
ISO 15004-2:2007(E)
3.2 Symbols
Symbols, quantities and units are listed in Table 1.
Table 1 — Symbols, quantities and units
Symbol Quantity Unit
2
E irradiance (at a point on a surface) W/cm
2
E spectral irradiance W/(cm ⋅nm)
λ
2
L radiance (in a given direction at a given point of a real or imaginary surface) W/(sr⋅cm )
. 2.
L spectral radiance (for a wavelength interval dλ, in a given direction at a given point) W/(sr cm nm)
λ
2
L time-integrated radiance J/(sr⋅cm )
i
2
H radiant exposure (at a point of a surface, for a given duration) J/cm
2
H spectral radiant exposure J/(cm ⋅nm)
λ
2
E S(λ) weighted corneal and lenticular ultraviolet radiation irradiance W/cm
S-CL
2
E unweighted corneal and lenticular ultraviolet radiation irradiance W/cm
UV-CL
2
E A(λ) weighted retinal irradiance W/cm
A-R
2
E unweighted corneal and lenticular infrared radiation irradiance W/cm
IR-CL
2
E unweighted anterior segment visible and infrared radiation irradiance W/cm
VIR-AS
2
E R(λ) weighted retinal visible and infrared radiation thermal irradiance W/cm
VIR-R
2
L A(λ) weighted retinal radiance W/(sr⋅cm )
A-R
2
L A(λ) weighted retinal time-integrated radiance J/(sr⋅cm )
i,A-R
2
L R(λ) weighted, retinal visible and infrared radiation time-integrated radiance J/(sr⋅cm )
i,VIR-R
2
L R(λ) weighted retinal visible and infrared radiation radiance W/(sr⋅cm )
VIR-R
2
H R(λ) weighted retinal visible and infrared radiation radiant exposure J/cm
VIR-R
2
H unweighted corneal and lenticular infrared radiation radiant exposure J/cm
IR-CL
2
H unweighted anterior segment visible and infrared radiation radiant exposure J/cm
VIR-AS
2
H S(λ) weighted corneal and lenticular ultraviolet radiation radiant exposure J/cm
S-CL
2
H unweighted corneal and lenticular ultraviolet radiation radiant exposure J/cm
UV-CL
2
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) —
R(λ) visible and infrared radiation thermal hazard weighting function (see Annex A) —
∆λ summation interval nm
exposure time;
t for pulsed instruments: exposure time for a single pulse and for any group of pulses the s
instrument is capable of producing
∆t pulse width up to a time of 0,25 s s
. 2.
E t spectral radiant exposure J/(cm nm)
λ
. 2.
(E ∆t) spectral radiant exposure at time ∆t J/(cm nm)
λ
© ISO 2007 – All rights reserved 5
---------------------- Page: 12 ----------------------
ISO 15004-2:2007(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.
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.
Scanning instruments shall be evaluated using the pulsed instrument criteria when the scan lengths are
greater than the diameter of the measurement aperture. Where the scan length is less than or equal to the
measurement aperture, they shall be evaluated using the continuous wave criteria.
5.2 Requirements for classification as a Group 1 instrument
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 specified for Group 1, then measurements shall be required only for the
unblocked wavelengths, but not for the blocked wavelengths.
c) Its only sources of radiation are Class 1 lasers as classified under IEC 60825-1:2001.
d) 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.
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 2 h exposure. These limits apply to all
instruments except operation microscopes, endoilluminators, and instruments designed for continuous
exposure. For operation microscopes and endoilluminators, the limits for Group 1 shall be further reduced by
a factor of 2. 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.
6 © ISO 2007 – All rights reserved
---------------------- Page: 13 ----------------------
ISO 15004-2:2007(E)
5.3 Requirements for Group 2 instruments
5.3.1 Group 2 instruments shall comply with the emission limits and guideline values given in 5.5.
5.3.2 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 the unblocked wavelengths, but not for the blocked wavelengths.
5.3.3 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.
5.3.4 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 equations given for them in Table 2 shall be used. See Table 1 for an
explanation of the quantities used in the equations and for associated units.
If wavelengths 250 nm to 400 nm are not emitted by the source or are blocked by filtration, the measurements
of Table 2, 5.4.1.1 and 5.4.1.2 are not required.
Table 2 — Group 1 limit values for continuous wave instruments
Wavelength
Parameter Equation Limit
nm
2
5.4.1.1 Weighted corneal and lenticular ultraviolet 250 to 400 400
0,4 µW/cm
radiation irradiance, E
EE= ××S λ∆λ
()
S-CL
SC− L ∑ λ
250
The corneal and lenticular ultraviolet radiation irradiance shall be
evaluated by averaging the highest localized radiant power incident
upon a circular area at the corneal plane with a diameter of 1 mm
−3 2
(7,9 × 10 cm ).
2
5.4.1.2 Unweighted corneal and lenticular 360 to 400 400
1 mW/cm
ultraviolet radiation irradiance, E
EE= ×∆λ
UV-CL UV−CL
∑ λ
360
The corneal and lenticular ultraviolet radiation irradiance shall be
evaluated by averaging the highest localized radiant power incident
upon a circular area at the corneal plane with a diameter of 1 mm
−3 2
(7,9 × 10 cm ).
© ISO 2007 – All rights reserved 7
---------------------- Page: 14 ----------------------
ISO 15004-2:2007(E)
Table 2 (continued)
Wavelength
Parameter Equation Limit
nm
5.4.1.3 Retinal photochemical aphakic light hazard
The limit values given in a) and b) are
equivalent. It is only necessary to evaluate
the retinal photochemical aphakic light
hazard with either a) or b) below.
2
a) Weighted retinal irradiance, E 305 to 700 700
220 µW/cm
A-R
EE= ××A()λ∆λ
AR− λ
∑
305
The retinal irradiance shall be the radiant power detectable through
a 7 mm diameter aperture at the cornea and shall be evaluated by
averaging the highest localized radiant power incident upon a
circular area on the retina with a diameter of 0,18 mm
−4 2
(2,54 × 10 cm ). However, if the instrument is intended to be used
−6 2
with an eye that is immobilized, a 0,03 mm (7,07 × 10 cm )
diameter aperture shall be used instead of a 0,18 mm diameter
aperture.
Weighted retinal radiance, L
b) 700
A-R
2
LL= ××A λ∆λ
305 to 700 ()
2 mW/(sr⋅cm )
AR− ∑ λ
305
Measu
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.