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)

This document specifies fundamental requirements for non-invasive, active and non-active ophthalmic instruments and to devices for enhancing low vision. This document is also applicable to tonometers, but not to other ophthalmic instruments which are used in contact with the globe of the eye.
This document 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 alle ophthalmischen Instrumente (ISO 15004-1:2020)

Dieses Dokument legt grundlegende Anforderungen für nicht-invasive, aktive und nicht-aktive ophthalmische Instrumente und für Sehhilfen für Sehbehinderte fest. Dieses Dokument ist auch für Tonometer anzuwenden, jedoch nicht für andere ophthalmische Instrumente, die im Kontakt mit dem Augapfel benutzt werden.
Dieses Dokument ist nicht anzuwenden 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 15004-1:2020)

Le présent document spécifie les exigences fondamentales s'appliquant aux instruments ophtalmiques non invasifs, actifs et non actifs, et aux dispositifs pour malvoyants. Il est également applicable aux tonomètres, mais ne s'applique pas aux autres instruments ophtalmiques utilisés au contact du globe oculaire.
Le présent document ne s'applique pas aux microscopes chirurgicaux, aux endoscopes ou aux instruments destinés à l'examen ou au traitement de l'œil par laser.

Oftalmični instrumenti - Temeljne zahteve in preskusne metode - 1. del: Splošne zahteve, uporabne za vse oftalmične instrumente (ISO 15004-1:2020)

General Information

• Status: Published
• Publication Date: 24-Nov-2020
• Withdrawal Date: 30-May-2021
• ICS: 11.040.70 - Ophthalmic equipment
• Technical Committee: CEN/TC 170 - Ophthalmic optics
• Drafting Committee: CEN/TC 170 - Ophthalmic optics
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 25-Nov-2020
• 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 15004-1:2021 - Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004-1:2020)

Relations

• Replaces: 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: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 15004-1:2021
01-januar-2021
Nadomešča:
SIST EN ISO 15004-1:2009
Oftalmični instrumenti - Temeljne zahteve in preskusne metode - 1. del: Splošne
zahteve, uporabne za vse oftalmične instrumente (ISO 15004-1:2020)
Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General
requirements applicable to all ophthalmic instruments (ISO 15004-1:2020)
Ophthalmische Instrumente - Grundlegende Anforderungen und Prüfverfahren - Teil 1:
Allgemeine Anforderungen an ophthalmische Instrumente (ISO 15004-1:2020)
Instruments ophtalmiques - Exigences fondamentales et méthodes d'essai - Partie 1:
Exigences générales applicables à tous les instruments ophtalmiques (ISO 15004-
1:2020)
Ta slovenski standard je istoveten z: EN ISO 15004-1:2020
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 15004-1:2021 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 15004-1:2021

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SIST EN ISO 15004-1:2021


EN ISO 15004-1
EUROPEAN STANDARD

NORME EUROPÉENNE

November 2020
EUROPÄISCHE NORM
ICS 11.040.70 Supersedes EN ISO 15004-1:2009
English Version

Ophthalmic instruments - Fundamental requirements and
test methods - Part 1: General requirements applicable to
all ophthalmic instruments (ISO 15004-1:2020)
Instruments ophtalmiques - Exigences fondamentales Ophthalmische Instrumente - Grundlegende
et méthodes d'essai - Partie 1: Exigences générales Anforderungen und Prüfverfahren - Teil 1: Allgemeine
applicables à tous les instruments ophtalmiques (ISO Anforderungen an ophthalmische Instrumente (ISO
15004-1:2020) 15004-1:2020)
This European Standard was approved by CEN on 5 September 2020.

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-CENELEC 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-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15004-1:2020 E
worldwide for CEN national Members.

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SIST EN ISO 15004-1:2021
EN ISO 15004-1:2020 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 15004-1:2021
EN ISO 15004-1:2020 (E)
European foreword
This document (EN ISO 15004-1:2020) has been prepared by Technical Committee ISO/TC 172 "Optics
and photonics" 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 May 2021, and conflicting national standards shall be
withdrawn at the latest by May 2021.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 15004-1:2009.
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,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 15004-1:2020 ha
...