SIST EN ISO 15004-1:2006
(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 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 a 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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 15004-1:2006
01-september-2006
1DGRPHãþD
SIST EN ISO 15004:2000
2IWDOPLþQLLQVWUXPHQWL±7HPHOMQH]DKWHYHLQSUHVNXVQHPHWRGH±GHO 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 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
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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 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 normative 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 International standard and Directive 93/42/EEC
Clauses/sub-clauses of Essential requirements (ERs) of Qualifying remarks/Notes
this International standard directive 93/42/EEC
4 I.1, I.2, I.3, I.4, I.6, II.7.1, II.7.3, Testing according to clause 7.
II.8.1, II.9.2, II.9.3, II.12.7.4
4.1 II.12.7.1
4.3 II.9.1
4.6 II.10.1, II.10.2
4.7 II.12.7.5 Testing according to 7.2.
4.8 II.12.7.1
5.1, 5.2 I.1, I.3, I.4, I.5, II.7.3, II.9.2, II.10.1, Testing according to clause 7.
II.12.7.5
6 I.1, I.2, I.3, I.4, I.6, II.7.1, II.7.3, Testing according to clause 7.
II.9.2, II.9.3, II.12.7.5
6.1 II.12.1, II.12.6, II.12.7.4 Testing according to clause 7.
6.3 II.11.1, II.11.3, II.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
EN ISO 15004-2.
8 I.2, II.8.1, II.11.4, II.13.1, II.13.2,
II.13.3, II.13.6
WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.
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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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ISO 15004-1:2006(E)
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ii © ISO 2006 – All rights reserved
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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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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 ISO/TC 172, Optics and photonics, Subcommittee SC 7,
Ophthalmic optics and instruments.
This first edition together with ISO 15004-2 cancels and replaces ISO 15004:1997, which has been technically
revised as follows:
a) all reference to light hazard (definitions 3.4 to 3.9, 6.3, 7.5, Annexes A, C and D of ISO 15004:1997) has
essentially been moved to ISO 15004-2;
b) ignitability requirement/testing changed (4.5.2 and 7.1 of ISO 15004:1997);
c) environmental requirements/testing partly changed [Table 1; 5.2.2 and 8.1 f) of ISO 15004:1997];
d) normative Annex B (now informative Annex A) entirely updated;
e) normative (dated) reference updated to use IEC 60601-1:2005 edition.
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 protec
...
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