SIST EN ISO 12866:2000
(Main)Ophthalmic instruments - Perimeters (ISO 12866:1999)
Ophthalmische Instrumente - Perimeter (ISO 12866:1999)
Diese Internationale Norm legt Anforderungen und Prüfverfahren füt 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 angewandten Untersuchungsstrategien und andere psychophysikalische Prüfungen des Gesichtsfeldes. Sofern Unterschiede bestehen hat diese Internationale Norm Vorrang gegenüber ISO 15004.
Instruments ophtalmiques - Périmetres (ISO 12866:1999)
La présente Norme internationale spécifie les exigences et méthodes d'essai portant sur les instruments conçus pour évaluer la sensibilité différentielle à la lumière dans le champ visuel par détection subjective de la présence d'un stimulus d'essai sur un fond défini La présente Norme internationale ne s'applique pas aux méthodologies cliniques ni autres essais psychologiques médicaux relatifs au champ visuel La présente Norme internationale est prioritaire sur la norme ISO 15004 lorsque des différences existent.
Oftalmični instrumenti- Perimetri (ISO 12866:1999)
General Information
- Status
- Published
- Publication Date
- 30-Jun-2000
- Technical Committee
- VAZ - Healthcare
- Current Stage
- 6060 - National Implementation/Publication (Adopted Project)
- Start Date
- 01-Jul-2000
- Due Date
- 01-Jul-2000
- Completion Date
- 01-Jul-2000
Relations
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 01-Jan-2009
- Effective Date
- 22-Dec-2008
Overview
SIST EN ISO 12866:2000 specifies the essential requirements and test methods for ophthalmic instruments known as perimeters. Perimeters are critical devices in ophthalmology, used to assess the sensitivity of the human visual field through the detection of specific light stimuli against a defined background. This international standard (ISO 12866:1999), adopted as the Slovenian version, ensures that ophthalmic perimeters provide reliable, accurate measurements consistent with global best practices.
Perimeters play a vital role in diagnosing and monitoring various eye conditions, such as glaucoma and neurological disorders. By establishing standardized requirements, SIST EN ISO 12866:2000 contributes to the safety, reliability, and interoperability of ophthalmic diagnostic equipment worldwide.
Key Topics
This standard addresses the following core topics related to ophthalmic perimeters:
- Definitions and Terminology: Establishes consistent terms for visual fields, types of perimeters (e.g., kinetic, static, projection), and test stimuli.
- General and Specific Requirements: Lists essential characteristics, such as test stimulus presentation, luminance measurement, stimulus location and size, and head positioning.
- Stimulus Types: Includes requirements for both kinetic (moving) and static (stationary) perimeters.
- Performance Testing: Outlines test methods for background luminance, stimulus luminance, location, size, shape, duration, and type testing for both projection and fixed-location perimeters.
- Documentation and Marking: Specifies the necessary accompanying documentation and permanent marking for traceability and compliance.
- Perimetric Coordinate Systems: Details both polar and Cartesian coordinate systems for reporting visual field data.
Applications
The practical value of SIST EN ISO 12866:2000 is evident across multiple aspects of the ophthalmic industry:
- Clinical Diagnostics: Ensures perimeters provide accurate and repeatable tests for visual field defects, supporting effective clinical decisions and early detection of conditions like glaucoma.
- Equipment Design and Manufacturing: Offers manufacturers a clear framework for designing perimeters that meet global safety, performance, and usability standards.
- Quality Control: Provides guidelines for validating the technical and functional performance of perimeters during production and post-market evaluation.
- International Trade: Facilitates the acceptance of compliant instruments across global markets by aligning with internationally recognized standards.
- User Safety and Effectiveness: By mandating features like proper fixation monitoring and stimulus consistency, the standard helps improve patient comfort, test reliability, and overall diagnostic value.
Related Standards
SIST EN ISO 12866:2000 references several other key standards to ensure a comprehensive regulatory environment for ophthalmic instruments:
- ISO 15004:1997 - Fundamental requirements and test methods for ophthalmic instruments.
- IEC 60601-1:1988 - General safety requirements for medical electrical equipment.
- IEC 60601-1-1:1992 - Safety requirements for medical electrical systems.
By adhering to these referenced standards in addition to ISO 12866, manufacturers and clinicians can ensure the highest levels of performance, safety, and interoperability for ophthalmic equipment.
Adopting SIST EN ISO 12866:2000 supports quality, safety, and global harmonization within the field of ophthalmic diagnostics, benefiting manufacturers, clinicians, and patients alike. For anyone involved in the design, testing, procurement, or clinical use of perimeters, understanding and implementing this standard is essential for excellence in ophthalmic care and device compliance.
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Frequently Asked Questions
SIST EN ISO 12866:2000 is a standard published by the Slovenian Institute for Standardization (SIST). Its full title is "Ophthalmic instruments - Perimeters (ISO 12866:1999)". This standard covers: La présente Norme internationale spécifie les exigences et méthodes d'essai portant sur les instruments conçus pour évaluer la sensibilité différentielle à la lumière dans le champ visuel par détection subjective de la présence d'un stimulus d'essai sur un fond défini La présente Norme internationale ne s'applique pas aux méthodologies cliniques ni autres essais psychologiques médicaux relatifs au champ visuel La présente Norme internationale est prioritaire sur la norme ISO 15004 lorsque des différences existent.
La présente Norme internationale spécifie les exigences et méthodes d'essai portant sur les instruments conçus pour évaluer la sensibilité différentielle à la lumière dans le champ visuel par détection subjective de la présence d'un stimulus d'essai sur un fond défini La présente Norme internationale ne s'applique pas aux méthodologies cliniques ni autres essais psychologiques médicaux relatifs au champ visuel La présente Norme internationale est prioritaire sur la norme ISO 15004 lorsque des différences existent.
SIST EN ISO 12866:2000 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 has the following relationships with other standards: It is inter standard links to SIST EN 1911-1:1999, SIST EN 573-5:2007, SIST EN ISO 15004:2000, SIST EN ISO 12866:2000/A1:2009, SIST EN ISO 12866:2000/AC:2000. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST EN ISO 12866:2000 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-julij-2000
2IWDOPLþQLLQVWUXPHQWL3HULPHWUL,62
Ophthalmic instruments - Perimeters (ISO 12866:1999)
Ophthalmische Instrumente - Perimeter (ISO 12866:1999)
Instruments ophtalmiques - Périmetres (ISO 12866:1999)
Ta slovenski standard je istoveten z: EN ISO 12866:1999
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
INTERNATIONAL ISO
STANDARD 12866
First edition
1999-06-01
Corrected and reprinted
1999-12-01
Ophthalmic instruments — Perimeters
Instruments ophtalmiques — Périmètres
A
Reference number
ISO 12866:1999(E)
ISO 12866:1999(E)
Contents
1 Scope .1
2 Normative references .1
3 Terms and definitions .1
4 Requirements.4
4.1 General.4
4.2 Specific requirements .4
4.3 Kinetic perimeters.5
4.4 Static perimeters.5
5 Test methods.6
5.1 Checking the background luminance.6
5.2 Checking stimulus luminance .6
5.3 Checking the test stimulus location .6
5.4 Checking the test stimulus size .6
5.5 Checking the stimulus shape .6
5.6 Checking the stimulus duration.6
5.7 Type tests .6
6 Accompanying documents.7
7 Marking .7
(informative)
Annex A Goldmann test stimulus specifications .8
Annex B (informative) Perimetric coordinate systems.10
© ISO 1999
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic
or mechanical, including photocopying and microfilm, without permission in writing from the publisher.
International Organization for Standardization
Case postale 56 • CH-1211 Genève 20 • Switzerland
Internet iso@iso.ch
Printed in Switzerland
ii
© ISO
ISO 12866:1999(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 3.
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.
International Standard ISO 12866 was prepared by Technical Committee ISO/TC 172, Optics and optical
instruments, Subcommittee SC 7, Ophthalmic optics and instruments.
Annexes A and B of this International Standard are for information only.
iii
INTERNATIONAL STANDARD © ISO ISO 12866:1999(E)
Ophthalmic instruments — Perimeters
1 Scope
This International Standard specifies requirements and test methods for instruments designed to assess differential
light sensitivity in the visual field by the subjective detection of the presence of test stimuli on a defined background.
It does not apply to clinical methodologies and other psychophysical tests of the visual field.
This International Standard takes precedence over ISO 15004, if differences exist.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of
this International Standard. For dated references, subsequent amendments to, or revisions of, any of these
publications do not apply. However, parties to agreements based on this International Standard are encouraged to
investigate the possibility of applying the most recent editions of the normative documents indicated below. For
undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC
maintain registers of currently valid International Standards.
ISO 15004:1997, Ophthalmic instruments — Fundamental requirements and test methods.
IEC 60601-1: 1988, Medical electrical equipment — Part 1: General requirements for safety.
IEC 60601-1-1:1992, Medical electrical systems — Part 1: General requirements for safety. 1. Collateral standard:
Safety requirements for medical electrical systems.
3 Terms and definitions
For the purposes of this International Standard, the following terms and definitions apply.
3.1
visual field
sum of all directions from which the eye may perceive visual stimulation at a defined moment in time and the
performance of the perception of this stimulation
3.1.1
monocular field
visual field of an individual perceived with a single eye
3.1.2
binocular field
visual field of an individual perceived with both eyes open
3.1.3
central field
visual field in all directions extending up to 30° from fixation
© ISO
ISO 12866:1999(E)
3.1.4
peripheral field
visual field in all directions beyond 30° from fixation
NOTE It is possible to discriminate between midperipheral and full-field.
3.2
perimeter
instrument to assess differential light sensitivity in the visual field by detection of the presence of test stimuli on a
defined background
3.2.1
fixed-location stimulus perimeter
perimeter which utilizes test stimuli that are at permanent locations on the background
3.2.2
projection perimeter
perimeter which utilizes a projection system to create the test stimuli on the background
3.2.3
kinetic perimeter
perimeter which utilizes moving test stimuli
3.2.4
static perimeter
perimeter which utilizes stationary test stimuli
3.3
test stimulus
stimulus used to determine differential light sensitivity in each tested location of the visual field
3.3.1
Goldmann test stimulus
set of sizes which can be used to specify test stimuli
See annex A.
3.3.2
stimulus duration
time from the defined onset to the defined end of the stimulus
3.3.3
test stimulus pattern
local distribution of a set of test stimuli
3.4
stimulus luminance
L
S
luminance of the presented stimulus
NOTE The stimulus luminance includes the background luminance.
3.5
threshold stimulus luminance
L
T
luminance of the test stimulus which has a 50 % detection rate for a given set of test parameters
3.6
background luminance
L
B
luminance of the surround within which the test stimuli are presented
© ISO
ISO 12866:1999(E)
3.7
differential luminance
DL
difference between stimulus luminance L and the background luminance L
S B
DL = L 2 L
S B
3.7.1
threshold differential luminance
DL
T
difference between the threshold stimulus luminance L and the background luminance
T
DL = L 2 L
T T B
3.7.2
Goldmann differential luminances
Set of luminance differentials which can be used to specify test stimulus differential luminance
See annex A.
3.8
contrast
ratio of the differential luminance DL to background luminance L
B
DL / L
B
3.9
differential light sensitivity
S
ratio of the background luminance L to the threshold differential luminance DL
B T
S = L /DL
B T
3.10
perimeter decibel scale
logarithmic scale used to express, in decibels, the differential light sensitivity, S, where the value of the background
luminance, L , is replaced within the formula by the defined maximum stimulus luminance of the specific instrument,
B
L , and where 0 dB represents this maximum stimulus luminance
max
S (in dB) = 10 log [L /DL ]
10 max T
NOTE The same scale is used to express stimulus luminance, L , by replacing the threshold differential luminance DL
S T
within the formula with the differential luminance DL.
3.11
suprathreshold strategy
supraliminal strategy
examination strategy designed for screening purposes, in which stimulus luminances of a defined amount above the
presumed threshold stimulus luminance are applied
3.12
threshold strategy
examination strategy which is designed to quantify the sensitivity in each test location by estimation of the threshold
stimulus luminance
3.13
fixation
direction in which the patient is required to look during the test
© ISO
ISO 12866:1999(E)
3.14
fixation target
target used to locate the point where the patient should look during testing
3.15
eccentricity
F
angle from fixation to a position in the visual field
See annex B.
4 Requirements
4.1 General
The requirements of this International Standard shall be verified through type testing. All te
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