EN ISO 15752:2010
(Main)Ophthalmic instruments - Endoilluminators - Fundamental requirements and test methods for optical radiation safety (ISO 15752:2010)
Ophthalmic instruments - Endoilluminators - Fundamental requirements and test methods for optical radiation safety (ISO 15752:2010)
ISO 15752:2010 specifies optical radiation safety aspects of endoilluminator light sources and endoilluminator light guides which are used to illuminate the interior of the eye during ocular surgery.
Ophthalmische Instrumente - Endoilluminatoren - Grundlegende Anforderungen und Prüfverfahren in Bezug auf die optische Strahlungssicherheit (ISO 15752:2010)
Diese Internationale Norm legt Anforderungen an die optische Strahlungssicherheit der Lichtquellen und Licht¬leiter von Endoilluminatoren fest, die während der Augenchirurgie zur Beleuchtung des Augeninneren ver¬wendet werden.
Instruments ophtalmiques - Sondes endolumineuses - Exigences fondamentales et méthodes d'essai relatives à la sécurité vis-à-vis des rayonnements optiques (ISO 15752:2010)
L'ISO 15752:2010 spécifie les aspects de sécurité, vis-à-vis des rayonnements optiques, des sources lumineuses et des guides de lumière des sondes endolumineuses utilisées pour éclairer l'intérieur de l'œil durant une chirurgie oculaire.
Oftalmični instrumenti - Sonde za osvetljevanje - Temeljne zahteve in preskusne metode za varnost pred optičnim sevanjem (ISO 15752:2010)
Ta mednarodni standard določa vidike varnosti pred optičnim sevanjem svetlobnih virov in svetlobnih vodil sond za osvetljevanje, ki se uporabljajo za osvetljevanje notranjosti očesa med očesno operacijo.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-junij-2010
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Ophthalmic instruments - Endoilluminators - Fundamental requirements and test
methods for optical radiation safety (ISO 15752:2010)
Ophthalmische Instrumente - Endoilluminatoren - Grundlegende Anforderungen und
Prüfverfahren in Bezug auf die optische Strahlungssicherheit (ISO 15752:2010)
Instruments ophtalmiques - Sondes endolumineuses - Exigences fondamentales et
méthodes d'essai relatives à la sécurité vis-à-vis des rayonnements optiques (ISO
15752:2010)
Ta slovenski standard je istoveten z: EN ISO 15752:2010
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
13.280 Varstvo pred sevanjem Radiation protection
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 15752
NORME EUROPÉENNE
EUROPÄISCHE NORM
January 2010
ICS 11.040.70
English Version
Ophthalmic instruments - Endoilluminators - Fundamental
requirements and test methods for optical radiation safety (ISO
15752:2010)
Instruments ophtalmiques - Sondes endolumineuses - Ophthalmische Instrumente - Endoilluminatoren -
Exigences fondamentales et méthodes d'essai relatives à Grundlegende Anforderungen und Prüfverfahren in Bezug
la sécurité vis-à-vis des rayonnements optiques (ISO auf die optische Strahlungssicherheit (ISO 15752:2010)
15752:2010)
This European Standard was approved by CEN on 9 January 2010.
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, Croatia, 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: Avenue Marnix 17, B-1000 Brussels
© 2010 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15752:2010: E
worldwide for CEN national Members.
Contents Page
Foreword .3
Foreword
This document (EN ISO 15752:2010) has been prepared by Technical Committee ISO/TC 172 "Optics and
photonics" 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 July 2010, and conflicting national standards shall be withdrawn at the
latest by July 2010.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
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, Croatia, 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 the United Kingdom.
Endorsement notice
The text of ISO 15752:2010 has been approved by CEN as a EN ISO 15752:2010 without any modification.
INTERNATIONAL ISO
STANDARD 15752
Second edition
2010-01-15
Ophthalmic instruments —
Endoilluminators — Fundamental
requirements and test methods for
optical radiation safety
Instruments ophtalmiques — Sondes endolumineuses — Exigences
fondamentales et méthodes d'essai relatives à la sécurité vis-à-vis des
rayonnements optiques
Reference number
ISO 15752:2010(E)
©
ISO 2010
ISO 15752:2010(E)
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ii © ISO 2010 – All rights reserved
ISO 15752:2010(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 15752 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 7,
Ophthalmic optics and instruments.
This second edition cancels and replaces the first edition (ISO 15752:2000), which has been technically
revised.
INTERNATIONAL STANDARD ISO 15752:2010(E)
Ophthalmic instruments — Endoilluminators — Fundamental
requirements and test methods for optical radiation safety
1 Scope
This International Standard specifies optical radiation safety aspects of endoilluminator light sources and
endoilluminator light guides which are used to illuminate the interior of the eye during ocular surgery.
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.
ISO 15004-2:2007, Ophthalmic instruments — Fundamental requirements and test methods — Part 2: Light
hazard protection
IEC 60601-1, Medical electrical equipment — Part 1: General requirements for basic safety and essential
performance
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 15004-2 and the following apply.
3.1
exit aperture
portion of the endoilluminator light guide from which light from the endoilluminator light source emerges
3.2
endoilluminator
device consisting of an endoilluminator light source and an associated fibre-optic endoilluminator light guide
that is intended for insertion into the eye to illuminate any portion of the interior of the eye
NOTE Adapted from ISO 15004-2:2007.
3.3
endoilluminator light guide
device that transmits light from the endoilluminator light source into the eye
3.4
chandelier
endoilluminator light guide intended to be positioned adjacent to the sclera with an output divergence half-
angle equal to or greater than 90°
3.5
pic
forceps
device incorporated into the tip of an endoilluminator light guide for tissue manipulation
ISO 15752:2010(E)
3.6
standard (endoilluminator light guide)
collimated (endoilluminator light guide)
type of endoilluminator light guide with an output divergence half-angle equal to or less than 40°
3.7
wide angle (endoilluminator light guide)
diffusing (endoilluminator light guide)
type of endoilluminator light guide with an output divergence half-angle greater than 40° but less than 90°
3.8
endoilluminator light source
device that produces and directs light into an endoilluminator light guide
3.9
Group 1 instrument
ophthalmic instrument for which no potential light hazard exists and that can be shown to fulfil the
requirements of ISO 15004-2:2007, 5.2
NOTE Adapted from ISO 15004-2:2007.
3.10
Group 2 instrument
ophthalmic instrument for which a potential light hazard exists and that does not fulfil the requirements of
ISO 15004-2:2007, 5.2
NOTE Adapted from ISO 15004-2:2007.
4 Requirements
4.1 Optical radiation hazard with endoilluminator light sources
4.1.1 General
Endoilluminator light sources shall comply with the light hazard protection requirements given in ISO 15004-2.
4.1.2 Determination of classification group
The endoilluminator light source shall be classified as a Group 1 or Group 2 instrument as defined in
ISO 15004-2:2007, Clause 4. The test methods given in Clause 5 of this International Standard, shall be used
to make this determination.
4.1.3 Requirements for Group 1 instruments
If the status is determined to be Group 1, there are no further requirements.
4.1.4 Requirements for Group 2 instruments
If the status is determined to be Group 2, the endoilluminator light source shall comply with the requirements
of ISO 15004-2:2007, 5.3 and Clause 7. In addition, Clause 6 of this International Standard shall apply.
Compliance with 5.3 of ISO 15004-2:2007 shall be verified using test methods given in Clause 5 of this
International Standard.
2 © ISO 2010 – All rights reserved
ISO 15752:2010(E)
4.2 Retinal protection
If the time to reach the aphakic weighted retinal radiant maximum exposure guideline is < 30 min at maximum
output, a retinal protection means shall be installed in the instrument to increase the time to W 30 min.
The status of the protection means, whether enabled or disabled, shall be clearly evident to the user during
surgery.
4.3 Stability of light intensity
The endoilluminator light source shall be designed to ensure that, when operated at maximum output,
differences in output due to ageing, maintenance, servicing and correctly rated lamp and component
replacements cannot reduce the time and/or number of pulses necessary to reach the maximum exposure
guideline below the level determined in accordance with ISO 15004-2:2007, 6.5. This shall be applicable
throughout the lifetime of the endoilluminator light source when maintained in accordance with the
manufacturer’s specifications.
Among other methods, this may be achieved by a risk management process.
5 Test methods
5.1 Determination of irradiance, spectral irradiance and spectrally weighted irradiance for
Group 1 and Group 2 instruments
For endoilluminators that produce a uniform beam on the retina, with a diameter greater than 1 mm at the
recommended use distance, the following shall apply.
For the determination of irradiance or spectrally weighted irradiance for standard/collimated light guides, the
maximum radiant power or spectrally weighted radiant power for each light source at maximum intensity shall
be determined over an averaging area of 1 mm in diameter at a distance of 15 mm from the exit aperture.
For the determination of irradiance or spectrally weighted irradiance for wide-angle/diffusing and chandelier
light guides, the maximum radiant power or spectrally weighted radiant power for each light source at
maximum intensity shall be determined over an averaging area of 1 mm in diameter at a distance of 18 mm
from the exit aperture.
For the determination of irradiance or spectrally weighted irradiance for pic/forceps light guides, the maximum
radiant power or spectrally weighted radiant power for each light source at maximum intensity shall be
determi
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