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)
ISO 15004-2:2007 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. It is also applicable to all new and emerging ophthalmic instruments that direct optical radiation into or at the eye.
ISO 15004-2:2007 does not apply to radiation that is in excess of limits specified in ISO 15004 and that is intended for treatment of the eye.
ISO 15004-2:2007 classifies ophthalmic instruments into either Group 1 or a Group 2 in order to distinguish instruments that are non-hazardous from those that are potentially hazardous.
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 lumière (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
01-julij-2007
1DGRPHãþD
SIST EN ISO 15004:2000
2IWDOPLþQLLQVWUXPHQWL2VQRYQH]DKWHYHLQSUHVNXVQHPHWRGHGHO =DãþLWD
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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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
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.
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
ISO 15004-2:2007(E)
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ii © ISO 2007 – All rights reserved
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 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
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 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
...
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