FprEN ISO 15004-2
(Main)Ophthalmic instruments - Fundamental requirements and test methods - Part 2: Light hazard protection (ISO/FDIS 15004-2:2015)
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)
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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.
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
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as defined in the Vienna Agreement.
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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.
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IN ADDITION TO THEIR EVALUATION AS
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ISO/DIS 15004-2:2014(E)
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NOTIFICATION OF ANY RELEVANT PATENT
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©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2014
oSIST prEN ISO 15004-2:2014
ISO/DIS 15004-2:2014(E)
Copyright notice
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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 condu
...
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