FprEN ISO 15004-2

Ophthalmic instruments - Fundamental requirements and test methods - Part 2: Light hazard protection (ISO/FDIS 15004-2:2015)

2016-02-09: WI ON HOLD - ISO WI cancelled at ISO level - CEN/TC 170 to advise on the future of this project at CEN level.

Ophthalmische Instrumente - Grundlegende Anforderungen und Prüfverfahren - Teil 2: Schutz gegen Gefährdung durch Licht (ISO/FDIS 15004-2:2015)

Instruments ophtalmiques - Exigences fondamentales et méthodes d'essai - Partie 2: Protection contre les dangers de la lumière (ISO/FDIS 15004-2:2015)

Oftalmični instrumenti - Osnovne zahteve in preskusne metode - 2. del: Zaščita pred nevarno svetlobo (ISO/DIS 15004-2:2014)

General Information

• Status: Not Published
• Publication Date: 25-Feb-2016
• ICS: 11.040.70 - Ophthalmic equipment
• Technical Committee: CEN/TC 170 - Ophthalmic optics
• Drafting Committee: CEN/TC 170 - Ophthalmic optics
• Current Stage: 5098 - Decision to abandon - Formal Approval
• Start Date: 16-Mar-2016
• Completion Date: 14-Apr-2025
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: kSIST prEN ISO 15004-2:2015 - Ophthalmic instruments - Fundamental requirements and test methods - Part 2: Light hazard protection (ISO/DIS 15004-2:2014)

Relations

• Revises: EN ISO 15004-2:2007 - Ophthalmic instruments - Fundamental requirements and test methods - Part 2: Light hazard protection (ISO 15004-2:2007)
• Effective Date: 19-Jan-2023

Overview

ISO 15004-2 (FprEN ISO 15004-2) - "Ophthalmic instruments - Fundamental requirements and test methods - Part 2: Light hazard protection" is a standards document developed under ISO/CEN for optical radiation safety of ophthalmic instruments. It defines classification, emission limits and test methods for instruments that direct light into or at the eye for diagnostic, illumination, measurement, imaging or alignment purposes. The standard is part of the ISO 15004 series (Part 1 covers general requirements). Note: the CEN work item status (2016-02-09) shows the ISO work item was cancelled and the CEN/TC 170 was to advise on future action.

Key topics and technical requirements

• Scope and applicability
  • Applies to ophthalmic devices that deliver optical radiation to the eye (excluding intentional therapeutic treatment beams; however limits may be used for non‑target tissues).
• Classification
  • Instruments are classified into Group 1 (non‑hazardous) or Group 2 (potentially hazardous) based on measured emissions and criteria in the standard.
• Emission and exposure limits
  • Defines emission limits and exposure limit values for different radiation regimes: continuous wave (CW), pulsed/time‑limited, and multiple‑source instruments.
• Measurement parameters
  • Uses radiometric quantities such as irradiance and radiance, and accounts for spectral weighting (Annex A).
• Test methods
  • Detailed measurement procedures for classifying devices and determining radiance/irradiance, time to reach recommended maximum exposures, pulse counting and area determination (see Clauses 6 and Annexes D–E).
• Manufacturer information
  • Specifies the information that manufacturers must supply about light emissions, classification and safe use.
• Supporting material
  • Annexes include spectral weighting functions, measurement instrument guidance, measurement methods, irradiance measurement guidance and a classification flowchart. Annex ZA maps the standard to EU Directive 93/42/EEC essentials.

Practical applications

• Use this standard to assess and document light hazard protection for slit lamps, ophthalmoscopes, operation microscopes, endoilluminators and other ophthalmic imaging/illumination systems.
• Supports risk assessments, product design choices (aperture/filters/limits), regulatory compliance and lab testing protocols.
• Informs lab test procedures for continuous and pulsed light sources and for establishing safe exposure times and pulse counts.

Who should use this standard

• Medical device manufacturers of ophthalmic instruments
• Test laboratories and compliance engineers performing optical safety testing
• Regulatory affairs professionals preparing technical files for markets in which CEN/ISO alignment is required
• Clinicians and safety officers assessing device safety and clinical use limitations

Related standards

• ISO 15004-1 (General requirements for ophthalmic instruments)
• Product-specific ophthalmic standards referenced in Annex B and regional medical device directives/regulations (e.g., EU medical device requirements).

Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN ISO 15004-2:2014
01-maj-2014
2IWDOPLþQLLQVWUXPHQWL2VQRYQH]DKWHYHLQSUHVNXVQHPHWRGHGHO=DãþLWD
SUHGQHYDUQRVYHWORER,62',6
Ophthalmic instruments - Fundamental requirements and test methods - Part 2: Light
hazard protection (ISO/DIS 15004-2:2014)
Ophthalmische Instrumente - Grundlegende Anforderungen und Prüfverfahren - Teil 2:
Schutz gegen Gefährdung durch Licht (ISO/DIS 15004-2:2014)
Instruments ophtalmiques - Exigences fondamentales et méthodes d'essai - Partie 2:
Protection contre les dangers de la lumièrePlus de détails (ISO/DIS 15004-2:2014)
Ta slovenski standard je istoveten z: prEN ISO 15004-2
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
oSIST prEN ISO 15004-2:2014 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

oSIST prEN ISO 15004-2:2014
oSIST prEN ISO 15004-2:2014
DRAFT INTERNATIONAL STANDARD
ISO/DIS 15004-2
ISO/TC 172/SC 7 Secretariat: DIN
Voting begins on: Voting terminates on:
2014-02-20 2014-07-20
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
[Revision of first edition (ISO 15004-2:2007)]
ICS: 11.040.70
ISO/CEN PARALLEL PROCESSING
This draft has been developed within the International Organization for
Standardization (ISO), and processed under the ISO lead mode of collaboration
as defined in the Vienna Agreement.
This draft is hereby submitted to the ISO member bodies and to the CEN member
bodies for a parallel five month enquiry.
Should this draft be accepted, a final draft, established on the basis of comments
received, will be submitted to a parallel two-month approval vote in ISO and
THIS DOCUMENT IS A DRAFT CIRCULATED
formal vote in CEN.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
To expedite distribution, this document is circulated as received from the
IN ADDITION TO THEIR EVALUATION AS
committee secretariat. ISO Central Secretariat work of editing and text
BEING ACCEPTABLE FOR INDUSTRIAL,
composition will be undertaken at publication stage.
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 15004-2:2014(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2014

oSIST prEN ISO 15004-2:2014
ISO/DIS 15004-2:2014(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
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ii © ISO 2014 – All rights reserved

oSIST prEN ISO 15004-2:2014
ISO/DIS 15004-2
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 . 5
4 Classification . 6
5 Requirements . 6
5.1 General . 6
5.2 Requirements for classification as a Group 1 instrument . 6
5.2.1 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. 14
6 Test methods . 15
6.1 General . 15
6.2 Measurements made to classify instruments into Group 1 or Group 2 . 15
6.3 Group 2 instruments: Measurements . 15
6.4 Determination of area . 15
6.5 Group 2 instruments: Determination of time and number of pulses to reach
recommended maximum exposure . 16
6.5.1 Determination of time to reach the recommended maximum exposure for weighted
corneal and lenticular ultraviolet radiation radiant exposure, H , t . 16
max
S-CL
6.5.2 Determination of time to reach the recommended maximum exposure for unweighted
corneal and lenticular ultraviolet radiation radiant exposure, H for t < 1 000 s, t . 16
max
UV-CL
6.5.3 Determination of time to reach the recommended maximum exposure for photochemical
aphakic retinal exposure, t . 16
max
6.5.4 Determination of the number of pulses necessary to reach the recommended maximum
exposure for photochemical aphakic retinal exposure, n (for pulsed instruments) . 17
max
7 Information supplied by the manufacturer . 17
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
C.1 General . 27
C.2 Method for finding the spectral radiance function L of a light source using available
λ
photometers and spectrometers or spectral power distribution information . 27
Annex D (normative) Measurement methods for radiance/irradiance . 31
D.1 Measurements to determine Group 1 status and to determine radiance/irradiance

parameter values for Group 2 instruments . 31
oSIST prEN ISO 15004-2:2014
ISO/DIS 15004-2
D.2 Method to determine E , E , E and E . 31
S-CL UV-CL IR-CL VIR-AS
D.3 Method to determine E . 31
A-R
D.4 Method to determine H , H , H and H . 32
S-CL UV-CL IR-CL VIR-AS
D.5 Method to determine H and H . 33
VIR-R A-R
D.6 Method to calculate d . 33
r
D.7 Example for determination of radiance from a measurement of irradiance . 34
Annex E (informative) Guidance on the direct measurement of irradiance . 36
E.1 Measurements of irradiance in corneal or pupillary plane . 36
E.2 Measurements of retinal irradiance . 36
Annex F (informative) Classification flowchart . 38
Annex ZA (informative) Relationship between this International Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical Devices . 40
Bibliography . 41

iv © ISO 2013 – All rights reserved

oSIST prEN ISO 15004-2:2014
ISO/DIS 15004-2
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 15004-2 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 7,
Ohthalmic optics and instruments and by Technical Committee CEN/TC 170, Ophthalmic optics in
collaboration.
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

oSIST prEN ISO 15004-2:2014
oSIST prEN ISO 15004-2:2014
DRAFT INTERNATIONAL STANDARD ISO/DIS 15004-2

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 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 In the case of the treatment beams of therapeutic devices, when conducting risk assessments for non-target
tissues, the limits given in this 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 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 standard also account for the
likelihoods that eyes may be dilated and that eyes and heads may be stabilised during ophthalmic examinations. See
Bibliography [1].
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.
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.
oSIST prEN ISO 15004-2:2014
ISO/DIS 15004-2
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 exposure limits given in Table 5
and 6.5 within a 24-hour period.
3.1.4
time-limited instrument
ophthalmic device, whose maximum exposure duration is limited and known.
3.1.5
effective aperture
portion of the aperture that limits the amount of light delivered to the retina
Note 1 to entry: For an obscured or noncircular aperture, it has an area equivalent to that of a non-obscured circular
aperture.
3.1.6
emission limit
maximum value of optical radiation output allowed
3.1.7
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
3.1.8
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.
3.1.9
Group 1 instrument
ophthalmic instrument for which no potential light hazard exists and that can be shown to fulfil the
requirements of 5.2
3.1.10
Group 2 instrument
ophthalmic instrument for which a potential light hazard exists and that does not fulfil the requirements of 5.2
3.1.11
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
oSIST prEN ISO 15004-2:2014
ISO/DIS 15004-2
Note 1 to entry: Irradiance is expressed in units of watts per square centimetre, W/cm .
3.1.12
manufacturer
natural or legal person who places the ophthalmic instrument on the market
3.1.13
maximum intensity
highest optical radiation emissions the instrument is capable of delivering under any and all conditions
3.1.14
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
3.1.15
optical radiation hazard
risk of damage to the eye by exposure to optical radiant energy
3.1.16
photoretinitis
retinal photochemically-induced injury 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.
3.1.17
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, ∆t, 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.
3.1.18
radiance
L
〈in a given direction at a given point of a real or imaginary surface〉 quantity defined by the formula
dφ
L = (2)
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 equation for L, the radiant power
i
dΦ is replaced by the radiant energy dQ.
oSIST prEN ISO 15004-2:2014
ISO/DIS 15004-2
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 ).
3.1.19
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
Equivalently, the radiant exposure is defined as the integral of the irradiance, E, at a given point over a given
duration, ∆t
H = E × dt (4)
∫
∆t
Note 1 to entry: Radiant exposure is expressed in Joules per square centimetre, J/cm .
3.1.20
scanning instrument
instrument that emits radiation having a time-varying direction, origin or pattern of propagation with regard to a
stationary frame of reference.
3.1.21
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
dφ(λ)
E = (5)
λ
dA × dλ
2.
Note 1 to entry: Spectral irradiance is expressed in watts per square centimetre nanometre, W/(cm nm).
3.1.22
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
dφ(λ)
L = (6)
λ
dA × cosθ × dΩ × dλ
. 2.
Note 1 to entry: Spectral radiance is expressed in watts per steradian square centimetre nanometre, W/(sr cm nm).
oSIST prEN ISO 15004-2:2014
ISO/DIS 15004-2
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) W/cm
E spectral irradiance W/(cm ⋅nm)
λ
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
L time-integrated radiance J/(sr⋅cm )
i
H radiant exposure (at a point of a surface, for a given duration) J/cm
H spectral radiant exposure J/(cm ⋅nm)
λ
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) —
∆λ summation interval nm
exposure time;
also:
t energy integration time; 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
∆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
oSIST prEN ISO 15004-2:2014
ISO/DIS 15004-2
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
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.
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 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.
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 recommended
A-R
maximum exposure for photochemical aphakic retinal exposure, t , as per 6.5.3.
max
oSIST prEN ISO 15004-2:2014
ISO/DIS 15004-2
5.2.1 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 classed 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 5.5.2.1 (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 classed as a Group 1 instrument for photochemical
aphakic light hazard if the value of the aphakic weighted retinal irradiance, E , is equal to or less than the
A-R
limit given by 5.4.1.3 (Table 2), where the value of the retinal spectral irradiance, E , used to calculate E
λ A-R
shall be found by dividing the power entering the eye at each wavelength interval, ∆λ, 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 informational reporting requirements of 7 b) need only be complied with if Group 1 requirements
are not fulfilled for 5.4.1.1 - Weighted corneal and lenticular ultraviolet radiation irradiance (Table 2) or 5.4.1.2
– Unweighted corneal and lenticular ultraviolet radiation radiant exposure (Table 2) or 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 find 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 5.2.1 for retinal visible and infrared
radiation thermal hazard shall be checked for compliance with Group 2 using the pulse and time-limited
instrument requirements, 5.5.2.1 (Table 5). The value of pulse width ∆t to be used in 5.5.2.1 shall be found
using the scan velocity, v , and the linear dimension of the beam cross-section in the scanning direction at the
s
retina, d , in the formula
r
d
r
Δt =
v
s
If the value of d is less than 0,03 mm, set d at 0,03 mm.
r r
For beams with a non-circular cross-section, the value of d shall be determined by averaging the maximum
r
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 5.5.2.1 the value of N, the number of pulses, is the number of times the scan
passes of the over circular aperture of 0,03 mm on the retina.
A scanning instrument that does not fulfil the requirements of 5.2.1 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 given in 5.2.1.
A-R
oSIST prEN ISO 15004-2:2014
ISO/DIS 15004-2
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 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.
Table 2 — Group 1 limit values for continuous wave instruments
Wavelength
Parameter
Equation Limit
nm
5.4.1.1 Weighted corneal and lenticular ultraviolet
E = E × S(λ)× ∆λ
radiation irradiance, E 250 to 400 0,8 µW/cm
S-CL ∑ λ
S-CL
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 3 mm
(0,07 cm ).
5.4.1.2 Unweighted corneal ultraviolet radiation 400
irradiance, E
E = E × ∆λ
360 to 400 1 mW/cm
UV-CL UV −CL λ
∑
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 3 mm
(0,07 cm ).
5.4.1.3 Retinal photochemical aphakic light hazard

E = E × A(λ)× ∆λ
305 to 700
A−R λ 440 µW/cm
∑
Weighted retinal irradiance, E
A-R
The retinal irradiance shall be evaluated by averaging the highest
localized radiant power incident upon a circular area on the retina
−4 2
with a diameter of 0,18 mm (2,54 × 10 cm ). However, if the
instrument is intended to be used with an eye that is immobilized, a
−6 2
0,03 mm (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.
oSIST prEN ISO 15004-2:2014
ISO/DIS 15004-2
Table 2 (continued)
Wavelength
Parameter
Equation Limit
nm
5.4.1.4 Unweighted corneal and lenticular infrared
radiation irradiance, E E = E × ∆λ
915 to 2 500
60 mW/cm
IR-CL IR−CL ∑ λ
The corneal irradiance shall be evaluated by averaging the highest
localized radiant power incident upon a circular area at the corneal
−2 2
plane with a diameter of 3.5 mm (9,6 × 10 cm ).
5.4.1.5 Unweighted anterior segment visible and 1200
infrared radiation irradiance, E E = E × ∆λ
380 to 1 200 4 W/cm
VIR−AS λ
VIR-AS ∑
This limit only applies to instruments that,
The unweighted anterior segment irradiance shall be evaluated at
in normal use, irradiate the eye with
the point of smallest beam diameter by locating the highest
beams that have a diameter of 2 mm or
localized radiant power and averaging the radiant power within a
less at any point between the anterior
circular area centred at that location having a diameter of 1,0 mm
surface of the cornea and the posterior −3 2
(7,9 × 10 cm ).
surface of the crystalline lens
5.4.1.6 Retinal visible and infrared radiation 1400
( )
thermal hazard E = E × R λ × ∆λ
380 to 1 400 0,7 W/cm
VIR−R ∑ λ
Weighted retinal visible and infrared
radiation thermal irradiance, E
VIR-R
The position of the highest irradiance found in the irradiated retinal
area shall be found. The weighted retinal visible and infrared
radiation irradiance value, E , shall then be calculated by
VIR-R
dividing the spectral radiant power, Φ , in watts, incident on the
VIR-R
retina in a 0,03 mm circular disc centred on the position of highest
−6 2
irradiance by the area of this disc (7,07 × 10 cm ). See Annex D
for instructions on the way to make this calculation.

5.4.2 Pulsed and time-limited instruments
The ultraviolet radiation and retinal photochemical limits for Group 1 pulsed and time-limited instruments shall
be evaluated by using the continuous wave instrument Group 1 criteria. In such cases, the criteria for
continuous wave instruments shall be modified by incorporating the time averaged values of repetitively
pulsed instruments. The time averaged value is given by the ratio of the maximum energy that can be
produced in a specific period of time to the time involved.
EXAMPLE 1 The time averaged limit for the weighted corneal and lenticular ultraviolet radiation irradiance E
S-CL
effective irradiance for an instrument that emits ten pulses in 5 s with an energy of 1 µJ/cm per pulse is
2 2 2
10 µJ/cm /5 s = 2 µW/cm . This, therefore, would exceed the limit of 0,8 µW/cm for the Group 1.
EXAMPLE 2 The time averaged irradiance for an instrument that emits two pulses in 10 s with an energy of 1 µJ/cm per
2 2 2
pulse would be 2 µJ/cm /10 s = 0,2 µW/cm . This is below the Group 1 limit of 0,8 µW/cm .
The emission limits specified in Table 3 relate to corneal, lenticular, anterior segment or retinal infrared
radiation radiant exposure as applied directly to the pulsed instruments criteria. These criteria shall apply both
to a single pulse and to any group of pulses. To evaluate the respective radiation hazard criteria, the
equations given for them in Table 3 shall be used. See Table 1 for an explanation of the quantities used in the
equations and for associated units.
Pulsed instruments shall be evaluated at their highest intensity output.
oSIST prEN ISO 15004-2:2014
ISO/DIS 15004-2
Table 3 — Group 1 visible and infrared radiation limit values for pulsed and time-limited instruments
Parameter Wavelength Equation Limit

nm
5.4.2.1 Weighted corneal and lenticular
E = E × S(λ)× ∆λ
250 to 400 0,8 µW/cm
ultraviolet radiation irradiance, S-CL ∑ λ
E
S-CL
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 3 mm (0,07 cm ).
5.4.2.2 Unweighted corneal ultraviolet 400
radiation irradiance, E E = E × ∆λ
360 to 400
1 mW/cm
UV-CL UV −CL ∑ λ
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 3 mm (0,07 cm ).
−13 −11
5.4.2.3 Weighted retinal visible and 380 to 1 400
10 s < ∆t < 10 s:
infrared radiation radiant H = ∆t × E ×R(λ)× ∆λ
VIR−R ∑ λ
2,0 mJ/cm
exposure, H
VIR-R
−11 −6
10 s < ∆t < 3 × 10 s:
4,0 mJ/cm
−6
3 × 10 s < ∆t < 0,625 ms:
3/4 2
60 ∆t J/cm
0,625 ms < ∆t < 0,25 s:
1/4 2
1,5 ∆t J/cm
0,25 s < ∆t < 300 s:
3/4 2
2,6 ∆t J/cm
The retinal radiant exposure shall be evaluated by averaging the highest
localized radiant energy incident upon a circular area on the retina with a
−6 2
diameter of 0,03 mm (7,07 × 10 cm ). See Annex D for instructions on the
way to make this calculation.
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 -5
If the exposure duration ∆t is less than 10 seconds, the value 10 seconds
shall be used for ∆t.
For time-limited instruments the value of ∆t used in the equation and in the
limit shall be the maximum exposure duration.
5.4.2.4 Unweighted corneal and 2500

lenticular infrared radiation 1/4 2

915 to 2 500 H = H × ∆λ 1,8 ∆t J/cm
∑
IR−CL λ
radiant exposure,
H
IR-CL
The corneal and lenticular radiant exposure shall be evaluated by averaging
the highest localized radiant energy incident upon a circular area at the
−3 2
corneal plane with a diameter of 1 mm (7,9 × 10 cm ).

oSIST prEN ISO 15004-2:2014
ISO/DIS 15004-2
Table 3 (continued)
Parameter Wavelength Equation Limit

nm
5.4.2.5 Unweighted anterior segment 1200

visible and infrared radiation
1/4 2
380 to 1 200 H = H × ∆λ 25 ∆t J/cm
∑
VIR−AS λ
radiant exposure, H
VIR-AS
This limit only applies to
The unweighted anterior segment irradiance shall be evaluated at the point of
instruments that, in normal use,
irradiate the eye with beams that smallest beam diameter by locating the highest localized radiant power and
averaging the radiant power within a circular area centred at that location
have a diameter of 2 mm or less
−3 2
at any point between the anterior having a diameter of 1,0 mm (7,9 × 10 cm ).
surface of the cornea and the
posterior surface of the
crystalline lens
5.4.3 Limit for multiple source instruments
The optical radiation emissions from instruments that are designed to direct optical radiation on to the same
point(s) in or on the eye from multiple light sources shall be below all applicable limits for each light source
alone. For all intended consecutive and/or simultaneous use of the light sources, the limit that is applicable for
each surface of the eye (cornea, lens, retina) is given by the expression:
(E,H ) (E,H ) (E,H )
1 2 i
+ + + ≤ 1 (7)
Limit Limit Limit
1 2 i
where
E is the quantity irradiance or effective irradiance;
H is the quantity radiant exposure or effective radiant exposure;
i is the ith source.
5.5 Emission and exposure limit values for Group 2 instruments
5.5.1 Continuous wave instruments
The emission limits specified in Table 4 relate to corneal and lenticular irradiance, anterior segment irradiance
and retinal irradiance, as applied directly to the continuous wave instruments criteria. To evalua
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