EN ISO 8612:2009

Ophthalmic instruments - Tonometers (ISO 8612:2009)

ISO 8612:2009, together with ISO 15004-1, specifies minimum requirements and the design compliance procedure for tonometers intended for routine clinical use in the estimation of intraocular pressure (IOP).
ISO 8612:2009 takes precedence over ISO 15004-1, if differences exist.

Ophthalmische Instrumente - Augentonometer (ISO 8612:2009)

Diese Internationale Norm legt zusammen mit ISO 15004-1 Mindestanforderungen und die Typprüfung
(Prüfung zur Einhaltung der Bauart) für Augentonometer fest, die zum routinemäßigen praktischen Gebrauch
bei der Bestimmung des intraokularen Druckes (IOD) dienen sollen.
Wenn Unterschiede vorliegen, hat diese Internationale Norm Vorrang vor ISO 15004-1.
ANMERKUNG Der wahre intraokulare Druck wird selten direkt gemessen, da dies invasiv erfolgen müsste. Da der
wahre intraokulare Druck praktisch nicht gemessen werden kann, werden statt dessen alternative Verfahren zur
Bestimmung eines Referenz-IOD angegeben (Anhang A und Anhang B).

Instruments ophtalmiques - Tonomètres (ISO 8612:2009)

L'ISO 8612:2009 spécifie, conjointement avec l'ISO 15004‑1, les exigences minimales auxquelles doivent satisfaire les tonomètres à usage clinique de routine destinés à mesurer la pression intraoculaire (PIO), ainsi que le mode opératoire de contrôle de conformité des appareils.
En cas de divergences entre les deux, l'ISO 8612:2009 prend le pas sur l'ISO 15004‑1.

Očesni instrumenti - Tonometri (ISO 8612:2009)

Ta mednarodni standard skupaj z ISO 15004-1 določa minimalne zahteve in postopke za skladnost modelov za tonometre, ki so namenjeni rutinski klinični uporabi pri oceni intraokularnega tlaka (IOT). Ta mednarodni standard ima prednost pred ISO 15004-1, če so med njima razlike.

General Information

• Status: Published
• Publication Date: 30-Sep-2009
• Withdrawal Date: 29-Apr-2010
• 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: 01-Oct-2009
• Completion Date: 01-Oct-2009
• Ref Project: SIST EN ISO 8612:2010 - Ophthalmic instruments - Tonometers (ISO 8612:2009)

Relations

• Replaces: EN ISO 8612:2001 - Ophthalmic instruments - Tonometers (ISO 8612:2001)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 8612:2010
01-januar-2010
1DGRPHãþD
SIST EN ISO 8612:2002
2þHVQLLQVWUXPHQWL7RQRPHWUL,62
Ophthalmic instruments - Tonometers (ISO 8612:2009)
Ophthalmische Instrumente - Augentonometer (ISO 8612:2009)
Instruments ophtalmiques - Tonomètres (ISO 8612:2009)
Ta slovenski standard je istoveten z: EN ISO 8612:2009
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 8612:2010 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 8612:2010

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SIST EN ISO 8612:2010


EUROPEAN STANDARD
EN ISO 8612

NORME EUROPÉENNE

EUROPÄISCHE NORM
October 2009
ICS 11.040.70 Supersedes EN ISO 8612:2001
English Version
Ophthalmic instruments - Tonometers (ISO 8612:2009)
Instruments ophtalmiques - Tonomètres (ISO 8612:2009) Ophthalmische Instrumente - Augentonometer (ISO
8612:2009)
This European Standard was approved by CEN on 10 September 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 8612:2009: E
worldwide for CEN national Members.

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SIST EN ISO 8612:2010
EN ISO 8612:2009 (E)
Contents Page
Foreword .3

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SIST EN ISO 8612:2010
EN ISO 8612:2009 (E)
Foreword
This document (EN ISO 8612:2009) 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 April 2010, and conflicting national standards shall be withdrawn at the
latest by April 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 8612:2001.
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 8612:2009 has been approved by CEN as a EN ISO 8612:2009 without any modification.

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SIST EN ISO 8612:2010

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SIST EN ISO 8612:2010

INTERNATIONAL ISO
STANDARD 8612
Second edition
2009-10-01


Ophthalmic instruments — Tonometers
Instruments ophtalmiques — Tonomètres





Reference number
ISO 8612:2009(E)
©
ISO 2009

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SIST EN ISO 8612:2010
ISO 8612:2009(E)
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