SIST EN ISO 15004-1:2009
(Main)Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments (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 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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 15004-1:2009
01-maj-2009
1DGRPHãþD
SIST EN ISO 15004-1:2006
2IWDOPLþQLLQVWUXPHQWL7HPHOMQH]DKWHYHLQSUHVNXVQHPHWRGHGHO 6SORãQH
]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.
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 the United Kingdom.
Endorsement notice
The text of ISO 15004-1:2006 has been approved by CEN as a EN ISO 15004-1:2009 without any
modification.
3
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SIST EN ISO 15004-1:2009
EN ISO 15004-1:2009 (E)
Annex ZA
(informative)
Relationship between this European Standard and the
Essential Requirements of EU Directive 93/42/EEC
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 Requirements of the
New Approach Directive 93/42/EEC on medical devices.
Once this standard is cited in the Official Journal of the European Communities under that Directive and has
been implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA.1 – Correspondence between this European Standard and Directive 93/42/EEC
Clause(s)/sub-clause(s) Essential Requirements (ERs) Qualifying remarks/Notes
of this EN of Directive 93/42/EEC
All clauses 1, 2, 3, 4, 5, 6 Testing according to clause 7.
6 a) This relevant Essential Requirement is not
addressed in EN ISO 15004-1.
This requirement will be addressed by the manu-
facturer's risk management process.
See EN ISO 14971 for risk management and
EN ISO 14155-1 and -2 for clinical investigation.
4.1 1, 2, 3, 4, 5, 6
4.2 1, 2, 7.5
4.3 3
4.4 9.1
4.5 7.1
4.6 8.1
4.7 10.1, 10.2
4.8 12.7.5 Testing according to clause 7.2.
4.9 9.2, 12.7.1
5.1 4, 9.2 Testing according to clause 7.
5.2 5, 9.2 Testing according to clause 7.
5.3 5, 9.2
6.1 12.6, 12.7.4
6.3 11.1, 11.2, 11.3, 11.4 In the previous edition (EN ISO 15004:1997) the
relevant requirements and test methods were
directly incorporated in the standard. In the present
revised edition, these requirements and test
methods have been referred to ISO 15004-2, and
they are hence now incorporated in the present
standard by means of a normative reference to
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SIST EN ISO 15004-1:2009
EN ISO 15004-1:2009 (E)
Clause(s)/sub-clause(s) Essential Requirements (ERs) Qualifying remarks/Notes
of this EN of Directive 93/42/EEC
EN ISO 15004-2.
8.1 13.1, 13.6 Essential Requirement 13.6 is only partly
addressed in EN ISO 15004-1: Essential
Requirement 13.6 g) relating to instructions in the
event of damage to the sterile packaging and to
appropriate methods of re-sterilization is not
addressed.
8.2 13.3 This relevant Essential Requirement is only partly
addressed in EN ISO 15004-1: Essential
Requirement 13.3 a) relating to authorized
representative is not addressed.
12.1 a) This relevant Essential Requirement is not
addressed in EN ISO 15004-1.
This requirement can be addressed by application
of other standards, e.g. IEC 60601-1-4, IEC 62304.
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
5
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SIST EN ISO 15004-1:2009
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SIST EN ISO 15004-1:2009
INTERNATIONAL ISO
STANDARD 15004-1
First edition
2006-06-01
Ophthalmic instruments — Fundamental
requirements and test methods —
Part 1:
General requirements applicable
to all ophthalmic instruments
Instruments ophtalmiques — Exigences fondamentales et méthodes
d'essai —
Partie 1: Exigences générales applicables à tous les instruments
ophtalmiques
Reference number
ISO 15004-1:2006(E)
©
ISO 2006
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SIST EN ISO 15004-1:2009
ISO 15004-1:2006(E)
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ii © ISO 2006 – All rights reserved
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SIST EN ISO 15004-1:2009
ISO 15004-1:2006(E)
Contents Page
Foreword. iv
1 Scope. 1
2 Normative references. 1
3 Terms and definitions. 2
4 Fundamental requirements (for non-active and active ophthalmic instruments). 2
4.1 General. 2
4.2 Design. 2
4.3 Performance. 2
4.4 Combination of different devices. 2
4.5 Materials. 3
4.6 Protection against contaminants . 3
4.7 Scales and displays. 3
4.8 Thermal hazards. 3
4.9 Mechanical hazards. 3
5 Environmental conditions (for non-active and active ophthalmic instruments). 3
5.1 Environmental conditions of use . 3
5.2 Storage conditions . 4
5.3 Transport conditions. 4
6 Particular requirements for active ophthalmic instruments . 5
6.1 Electrical safety. 5
6.2 Inapplicable clauses of IEC 60601-1:2005. 5
6.3 Optical radiation hazard. 5
7 Test methods. 5
7.1 Ignitability. 5
7.2 Surface temperatures. 5
7.3 Environmental conditions. 5
7.4 Checking electrical safety. 7
8 Information supplied by the manufacturer . 7
8.1 Accompanying documents. 7
8.2 Marking. 7
Annex A (informative) Product-related International Standards for ophthalmic instruments . 8
© ISO 2006 – All rights reserved iii
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SIST EN ISO 15004-1:2009
ISO 15004-1:2006(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 15004-1 was prepared by Technical Committee
...
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