EN ISO 15004-1:2009

Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004-1:2006)

ISO 15004-1:2006 specifies fundamental requirements for non-invasive, active and non-active ophthalmic instruments. ISO 15004-1:2006 is also applicable to low-vision aids and tonometers, but not to other ophthalmic instruments which are used in contact with the globe of the eye.
ISO 15004-1:2006 is not applicable to operation microscopes, endoscopes and devices intended for laser investigation or laser treatment of the eye.

Ophthalmische Instrumente - Grundlegende Anforderungen und Prüfverfahren - Teil 1: Allgemeine Anforderungen an ophthalmische Instrumente (ISO 15004-1:2006)

Dieser Teil von ISO 15004 legt grundlegende Anforderungen für nichtinvasive aktive und nichtaktive ophthalmische
Instrumente fest. Dieser Teil von ISO 15004 gilt auch für Sehhilfen für Schwachsichtige und Tonometer,
jedoch nicht für andere ophthalmische Instrumente, die im Kontakt mit dem Augapfel benutzt werden.
Dieser Teil von ISO 15004 gilt nicht für Operationsmikroskope, Endoskope und Geräte, die zur Untersuchung
oder Behandlung des Auges mit Hilfe von Lasern dienen.

Instruments ophtalmiques - Exigences fondamentales et méthodes d'essai - Partie 1: Exigences générales applicables à tous les instruments ophtalmiques (ISO 15004-1:2006)

L'ISO 15004-1:2006 spécifie les exigences fondamentales s'appliquant aux instruments ophtalmiques non invasifs, actifs et non actifs. Elle est également applicable aux instruments d'aide visuelle destinés aux visions déficientes ainsi qu'aux tonomètres, mais ne s'applique pas aux autres instruments ophtalmiques utilisés au contact du globe oculaire.
L'ISO 15004-1:2006 ne s'applique pas aux microscopes chirurgicaux, aux endoscopes ou aux instruments destinés à l'examen ou au traitement de l'oeil par laser.

Oftalmični instrumenti - Temeljne zahteve in preskusne metode - 1. del: Splošne zahteve, uporabne za vse oftalmične instrumente (ISO 15004-1:2006)

General Information

• Status: Withdrawn
• Publication Date: 07-Apr-2009
• Withdrawal Date: 24-Nov-2020
• ICS: 11.040.70 - Ophthalmic equipment
• Technical Committee: CEN/TC 170 - Ophthalmic optics
• Drafting Committee: CEN/TC 170 - Ophthalmic optics
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 25-Nov-2020
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 15004-1:2009 - Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004-1:2006)

Relations

• Replaces: EN ISO 15004-1:2006 - Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004-1:2006)
• Effective Date: 22-Dec-2008
• Replaced By: EN ISO 15004-1:2020 - Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004-1:2020)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 15004-1:2009
01-maj-2009
1DGRPHãþD
SIST EN ISO 15004-1:2006
2IWDOPLþQLLQVWUXPHQWL7HPHOMQH]DKWHYHLQSUHVNXVQHPHWRGHGHO6SORãQH
]DKWHYHXSRUDEQH]DYVHRIWDOPLþQHLQVWUXPHQWH,62
Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General
requirements applicable to all ophthalmic instruments (ISO 15004-1:2006)
Ophthalmische Instrumente - Grundlegende Anforderungen und Prüfverfahren - Teil 1:
Allgemeine Anforderungen an ophthalmische Instrumente (ISO 15004-1:2006)
Instruments ophtalmiques - Exigences fondamentales et méthodes d'essai - Partie 1:
Exigences générales applicables à tous les instruments ophtalmiques (ISO 15004-
1:2006)
Ta slovenski standard je istoveten z: EN ISO 15004-1:2009
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 15004-1:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 15004-1:2009

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SIST EN ISO 15004-1:2009
EUROPEAN STANDARD
EN ISO 15004-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2009
ICS 11.040.70 Supersedes EN ISO 15004-1:2006
English Version
Ophthalmic instruments - Fundamental requirements and test
methods - Part 1: General requirements applicable to all
ophthalmic instruments (ISO 15004-1:2006)
Instruments ophtalmiques - Exigences fondamentales et Ophthalmische Instrumente - Grundlegende Anforderungen
méthodes d'essai - Partie 1: Exigences générales und Prüfverfahren - Teil 1: Allgemeine Anforderungen an
applicables à tous les instruments ophtalmiques (ISO ophthalmische Instrumente (ISO 15004-1:2006)
15004-1:2006)
This European Standard was approved by CEN on 7 March 2009.
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: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15004-1:2009: E
worldwide for CEN national Members.

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SIST EN ISO 15004-1:2009
EN ISO 15004-1:2009 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4

2

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SIST EN ISO 15004-1:2009
EN ISO 15004-1:2009 (E)
Foreword
The text of ISO 15004-1:2006 has been prepared by Technical Committee ISO/TC 172 “Optics and optical
instruments” of the International Organization for Standardization (ISO) and has been taken over as EN ISO
15004-1:2009 by 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 October 2009, and conflicting national standards shall be withdrawn at
the latest by March 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.
This document supersedes EN ISO 15004-1:2006.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive 93/42/EEC, as
amended by Directive 2007/47/EC.
For relationship with EU Directive 93/42/EEC as amended by Directive 2007/47/EC, see informative Annex
ZA, which is an integral part of this document.
Accordin
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