SIST EN ISO 12866:2000/A1:2009
(Amendment)Ophthalmic instruments - Perimeters - Amendment 1 (ISO 12866:1999/Amd1:2008)
Ophthalmic instruments - Perimeters - Amendment 1 (ISO 12866:1999/Amd1:2008)
Ophthalmische Instrumente - Perimeter ÄNDERUNG 1 (ISO 12866:1999/Amd1:2008)
Diese Internationale Norm legt Anforderungen und Prüfverfahren für Instrumente fest, die dazu bestimmt sind,
die Empfindlichkeit für Leuchtdichteunterschiede im Gesichtsfeld mittels subjektiver Wahrnehmung von Prüfreizen
auf definiertem Umfeld zu ermitteln.
Sie gilt nicht für die angewandten Untersuchungsstrategien und andere psychophysikalische Prüfungen des
Gesichtsfeldes.
Sofern Unterschiede bestehen hat diese Internationale Norm Vorrang gegenüber !ISO 15004-1".
Instruments ophtalmiques - Périmètres - Amendement 1 (ISO 12866:1999/Amd1:2008)
Oftalmični instrumenti - Perimetri - Dopolnilo A1 (ISO 12866:1999/Amd1:2008)
General Information
- Status
- Published
- Publication Date
- 03-Dec-2008
- Technical Committee
- VAZ - Healthcare
- Current Stage
- 6060 - National Implementation/Publication (Adopted Project)
- Start Date
- 20-Nov-2008
- Due Date
- 25-Jan-2009
- Completion Date
- 04-Dec-2008
Relations
- Effective Date
- 01-Jan-2009
Overview
SIST EN ISO 12866:2000/A1:2009 is an important amendment to the international standard on ophthalmic instruments, specifically perimeters. Developed by ISO/TC 172 "Optics and optical instruments" in collaboration with CEN/TC 170 "Ophthalmic optics," this amendment updates and refines the original ISO 12866:1999 standard. Approved by CEN in November 2008, the amendment ensures consistent requirements and improved safety, performance, and usability of perimeters used in ophthalmic diagnostics across Europe and globally.
Perimeters are critical tools used to measure visual fields and detect abnormalities such as glaucoma or neurological disorders. This amendment specifies updates concerning normative data, software notifications, documentation requirements, and updated references to safety standards, making it essential for manufacturers, healthcare professionals, and regulatory bodies.
Key Topics
Normative References Update
The amendment updates normative references to important safety and ophthalmic equipment standards:- ISO 15004-1:2006 (Fundamental requirements and test methods for ophthalmic instruments)
- IEC 60601-1:2005 (General requirements for basic safety and essential performance of medical electrical equipment)
Normal Value Table Requirements
Perimeters must:- Compare tested locations against age-specific normal values using recommended stimulus and background parameters
- Specify the version number, issue date, size, and age range of the normative database used
- Print the version number of the normal value table on test reports
- Notify users in case of updates or changes to the normative database via software updates or other means
Accompanying Documentation Enhancements
Perimeters must be supplied with clear and comprehensive instructions for use, including:- Manufacturer’s name and address
- Confirmation of transport condition compliance in original packaging (per ISO 15004-1:2006)
- Additional documents required by IEC 60601-1:2005
- Specification of examination strategies to guide clinical use
Minimum Requirements for Normative Databases (Annex C)
The amendment introduces a normative annex defining strict criteria to ensure the reliability of the normative databases used by perimeters, including:- Predefined inclusion criteria for healthy eyes, covering visual acuity limits and exclusion of pathological conditions
- Criteria for minimum experience in perimetry testing
- Selection methods for eyes included in the database (only one eye per subject)
- Conditions to exclude unreliable examinations based on fixation behavior and false positive/negative responses
- Minimum sample sizes, including subjects under 30 and over 60 years to reflect age variability
Applications
SIST EN ISO 12866:2000/A1:2009 is highly relevant to a range of practical applications involving ophthalmic perimeter devices:
- Manufacturers can ensure product compliance with up-to-date international safety and performance requirements, improving device reliability and market access in CEN member countries.
- Ophthalmologists and Optometrists benefit from improved normative data transparency and device standardization, leading to more accurate and consistent visual field assessments.
- Regulatory Authorities use this standard as a benchmark for approving perimeter devices and safeguarding patient safety through harmonized testing and documentation requirements.
- Healthcare Facilities can optimize device selection and maintenance informed by compliance with this amendment, enhancing diagnostic accuracy and patient care quality.
Related Standards
This amendment complements and references several key standards in the ophthalmic instrument and medical electrical equipment domains:
- ISO 12866:1999 - Original international standard for ophthalmic perimeters
- ISO 15004-1:2006 - Ophthalmic instruments – General requirements and test methods
- IEC 60601-1:2005 - Medical electrical equipment – Safety and essential performance
- CEN/CENELEC Internal Regulations - Requirements governing implementation and harmonization of European standards
Adherence to these interconnected standards enables manufacturers and users to maintain high levels of product safety, performance, and interoperability in ophthalmic diagnostics globally.
Keywords: Ophthalmic instruments standard, perimeters amendment, EN ISO 12866, normative database requirements, visual field testing, ophthalmic device safety, ISO 15004-1, IEC 60601-1, ophthalmic optics standards, CEN standards compliance.
Frequently Asked Questions
SIST EN ISO 12866:2000/A1:2009 is a amendment published by the Slovenian Institute for Standardization (SIST). Its full title is "Ophthalmic instruments - Perimeters - Amendment 1 (ISO 12866:1999/Amd1:2008)". This standard covers: Diese Internationale Norm legt Anforderungen und Prüfverfahren für Instrumente fest, die dazu bestimmt sind, die Empfindlichkeit für Leuchtdichteunterschiede im Gesichtsfeld mittels subjektiver Wahrnehmung von Prüfreizen auf definiertem Umfeld zu ermitteln. Sie gilt nicht für die angewandten Untersuchungsstrategien und andere psychophysikalische Prüfungen des Gesichtsfeldes. Sofern Unterschiede bestehen hat diese Internationale Norm Vorrang gegenüber !ISO 15004-1".
Diese Internationale Norm legt Anforderungen und Prüfverfahren für Instrumente fest, die dazu bestimmt sind, die Empfindlichkeit für Leuchtdichteunterschiede im Gesichtsfeld mittels subjektiver Wahrnehmung von Prüfreizen auf definiertem Umfeld zu ermitteln. Sie gilt nicht für die angewandten Untersuchungsstrategien und andere psychophysikalische Prüfungen des Gesichtsfeldes. Sofern Unterschiede bestehen hat diese Internationale Norm Vorrang gegenüber !ISO 15004-1".
SIST EN ISO 12866:2000/A1:2009 is classified under the following ICS (International Classification for Standards) categories: 11.040.70 - Ophthalmic equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN ISO 12866:2000/A1:2009 has the following relationships with other standards: It is inter standard links to SIST EN ISO 12866:2000. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST EN ISO 12866:2000/A1:2009 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2009
2IWDOPLþQLLQVWUXPHQWL3HULPHWUL'RSROQLOR$ ,62 $PG
Ophthalmic instruments - Perimeters - Amendment 1 (ISO 12866:1999/Amd1:2008)
Ophthalmische Instrumente - Perimeter ÄNDERUNG 1 (ISO 12866:1999/Amd1:2008)
Instruments ophtalmiques - Périmètres - Amendement 1 (ISO 12866:1999/Amd1:2008)
Ta slovenski standard je istoveten z: EN ISO 12866:1999/A1:2008
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 12866:1999/A1
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2008
ICS 11.040.70
English Version
Ophthalmic instruments - Perimeters - Amendment 1 (ISO
12866:1999/Amd1:2008)
Instruments ophtalmiques - Périmètres - Amendement 1 Ophthalmische Instrumente - Perimeter ÄNDERUNG 1
(ISO 12866:1999/Amd1:2008) (ISO 12866:1999/Amd1:2008)
This amendment A1 modifies the European Standard EN ISO 12866:1999; it was approved by CEN on 29 November 2008.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of this
amendment into the relevant 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 amendment 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: rue de Stassart, 36 B-1050 Brussels
© 2008 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 12866:1999/A1:2008: E
worldwide for CEN national Members.
Contents Page
Foreword .3
Foreword
This document (EN ISO 12866:1999/A1:2008) 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 Amendment to the European Standard EN ISO 12866:1999 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by May 2009, and
conflicting national standards shall be withdrawn at the latest by May 2009.
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.
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 12866:1999/Amd.1:2008 has been approved by CEN as a EN ISO 12866:1999/A1:2008
without any modification.
INTERNATIONAL ISO
STANDARD 12866
First edition
1999-06-01
AMENDMENT 1
2008-11-15
Ophthalmic instruments — Perimeters
AMENDMENT 1
Instruments ophtalmiques — Périmètres
AMENDEMENT 1
Reference number
ISO 12866:1999/Amd.1:2008(E)
©
ISO 2008
ISO 12866:1999/Amd.1:2008(E)
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