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)

This part of ISO 15004 specifies fundamental requirements for non-invasive, active and non-active ophthalmic instruments. This part of ISO 15004 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. This part of ISO 15004 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 ophthal¬mi¬sche Instrumente fest. Dieser Teil von ISO 15004 gilt auch für Sehhilfen für Schwachsichtige und Tono¬meter, 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 Be¬hand¬lung 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)

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• Status: Withdrawn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: 31-May-2006
• Withdrawal Date: 07-Apr-2009
• 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
• Start Date: 08-Apr-2009
• Completion Date: 08-Apr-2009
• 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 15004-1:2006 - Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004-1:2006)

Relations

• Replaces: EN ISO 15004:1997 - Ophthalmic instruments - Fundamental requirements and test methods (ISO 15004:1997)
• Effective Date: 22-Dec-2008
• Replaced By: 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)
• Effective Date: 22-Dec-2008

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 15004-1:2006
01-september-2006
1DGRPHãþD
SIST EN ISO 15004:2000
2IWDOPLþQLLQVWUXPHQWL±7HPHOMQH]DKWHYHLQSUHVNXVQHPHWRGH±GHO6SORãQH
]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 a tous les instruments ophtalmiques (ISO 15004-
1:2006)
Ta slovenski standard je istoveten z: EN ISO 15004-1:2006
ICS:
11.040.70
SIST EN ISO 15004-1:2006 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 15004-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2006
ICS 11.040.70 Supersedes EN ISO 15004:1997
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 9 January 2006.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, 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
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15004-1:2006: E
worldwide for CEN national Members.

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EN ISO 15004-1:2006 (E)





Foreword


This document (EN ISO 15004-1:2006) 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 December 2006, and conflicting national
standards shall be withdrawn at the latest by December 2006.

This document, together with prEN ISO 15004-2:2006, supersedes EN ISO 15004:1997.

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(s).

For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this
document.

According to the CEN/CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, 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 15004-1:2006 has been approved by CEN as EN ISO 15004-1:2006 without any
modifications.

2

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EN ISO 15004-1:2006 (E)



ANNEX ZA
(informative)

Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices



This European Standard has been prepared under a mandate given to CEN by the European
Commission and the European Free Trade Association to provide a means of conforming to
Essential Requirement
...