kSIST prEN ISO 15004-2:2015
(Main)Ophthalmic instruments - Fundamental requirements and test methods - Part 2: Light hazard protection (ISO/DIS 15004-2:2014)
Ophthalmic instruments - Fundamental requirements and test methods - Part 2: Light hazard protection (ISO/DIS 15004-2:2014)
2013-12-12 EMA: Draft for // ENQ received in ISO/CS (see notification of 2013-12-11 in dataservice).
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)
Oftalmični instrumenti - Osnovne zahteve in preskusne metode - 2. del: Zaščita pred nevarno svetlobo (ISO/DIS 15004-2:2014)
General Information
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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.
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oSIST prEN ISO 15004-2:2014
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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
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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
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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
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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
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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
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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.
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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
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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.
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2
Note 2 to entry: Radiance is expressed in watts per steradian square centimetre, W/(sr⋅cm ); time-integrated radiance
2
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
2
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).
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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) —
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
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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
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5.2.1 Requirements for classification as Group 1 for a scanning instrument
An ophthalmic instrument that images the retina or the anterior segmen
...
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