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
SIST EN ISO 15004-2:2007
01-julij-2007
1DGRPHãþD
SIST EN ISO 15004:2000
2IWDOPLþQLLQVWUXPHQWL2VQRYQH]DKWHYHLQSUHVNXVQHPHWRGHGHO =DãþLWD
SUHGQHYDUQRVYHWORER ,62
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
SIST EN ISO 15004-2:2007 en;fr;de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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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.
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EN ISO 15004-2:2007 (E)
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.
2
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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
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ISO 15004-2:2007(E)
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