SIST EN ISO 12866:2000
(Main)Ophthalmic instruments - Perimeters (ISO 12866:1999)
- 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
SIST EN ISO 12866:2000 is the Slovenian adoption of EN ISO 12866:1999 and ISO 12866:1999 for ophthalmic perimeters. It specifies requirements and test methods for instruments that assess differential light sensitivity in the visual field by detecting test stimuli on a defined background, for use by manufacturers, test laboratories, and anyone specifying or checking these instruments.
What does SIST EN ISO 12866:2000 specify?
SIST EN ISO 12866:2000 covers perimeters used in ophthalmic testing. It applies to instruments that measure visual field sensitivity through the subjective detection of test stimuli, and it excludes clinical methodologies and other psychophysical visual-field tests.
The document is organized into scope, normative references, terms and definitions, requirements, test methods, accompanying documents, and marking. It also has two informative annexes that support stimulus specification and location coding.
| Annex | What it covers |
|---|---|
| Annex A | Goldmann test stimulus specifications, including the standard stimulus sizes and differential luminances |
| Annex B | Perimetric coordinate systems for describing stimulus locations in the visual field |
What are the key requirements of SIST EN ISO 12866:2000?
SIST EN ISO 12866:2000 requires type testing for verification, and it relies on the general requirements of ISO 15004 plus the specific requirements in its own clauses. In practice, this means a perimeter must be checked as a finished instrument, not just by design review.
- Clause 4.2 sets the basic performance limits. The background and test stimuli must meet defined tolerances for luminance, contrast, location, size, duration, and background extent. This matters because the visual-field result depends directly on how accurately the stimulus is presented.
- Clause 4.2 also fixes what the manufacturer must specify. The standard requires specification of background and stimulus luminance in cd/m2, spectral distribution, stimulus size and shape, viewing distance, and refractive correction for that distance. For a buyer or user, this defines the instrument data that must be available before testing patients.
- Clause 4.2 requires patient handling features. The instrument must provide head positioning, fixation monitoring, and a way to measure sensitivity at fixation. It also requires the instrument to define each tested location and quantify the result from each location.
- Clause 4.2 defines the test field coverage. Central-field, midperipheral-field, and full-field perimeters must meet minimum eccentricity and minimum location counts. This matters when comparing models, because it tells you how far and how widely the field can be sampled.
- Clause 4.3 covers kinetic perimeters. Automatic movement must be smooth and continuous, and the movement speed and characteristics must be specified; manual movement must also be smooth in any direction. This is important for consistent kinetic field mapping.
- Clause 4.4 covers static perimeters. The temporal characteristics of stimulus presentation must be specified, and the location of each stimulus must be given in polar or Cartesian coordinates. That lets users document the test pattern unambiguously.
- Clause 5 gives the test methods. The standard describes how to check background luminance, stimulus luminance, stimulus location, size, shape, and duration, and it defines type-test locations for projection perimeters and fixed-position stimulus perimeters. In practice, this is the acceptance and conformance route.
- Clauses 6 and 7 control the user information and marking. The perimeter must be supplied with instructions for use, specified examination strategies, and the required identification and compliance marking, including software release identification for software-driven perimeters.
What terms does SIST EN ISO 12866:2000 define?
- Visual field - The range of directions from which the eye can perceive visual stimulation at a given moment.
- Perimeter - An instrument that assesses differential light sensitivity in the visual field using test stimuli on a defined background.
- Kinetic perimeter - A perimeter that uses moving test stimuli.
- Static perimeter - A perimeter that uses stationary test stimuli.
- Threshold stimulus luminance - The stimulus luminance detected at a 50% detection rate for a given test setup.
- Differential light sensitivity - The ratio of background luminance to threshold differential luminance.
- Perimeter decibel scale - The logarithmic scale used to express sensitivity in dB, based on the instrument’s maximum stimulus luminance.
- Eccentricity - The angle from fixation to a position in the visual field.
Who uses SIST EN ISO 12866:2000?
SIST EN ISO 12866:2000 is used by manufacturers and suppliers of ophthalmic perimeters, by test and calibration laboratories, and by engineers who verify stimulus geometry, luminance, and movement. It is also relevant to quality, regulatory, and purchasing teams that need to compare instruments, check required documentation, and confirm that a perimeter is suitable for central, midperipheral, or full-field testing.
Which standards are used with SIST EN ISO 12866:2000?
SIST EN ISO 12866:2000 names these normative references:
- ISO 15004:1997 - Provides the fundamental requirements and test methods for ophthalmic instruments, and this standard points to it for general requirements.
- IEC 60601-1:1988 - Sets general safety requirements for medical electrical equipment.
- IEC 60601-1-1:1992 - Adds safety requirements for medical electrical systems.
What does the SIST EN ISO 12866:2000 document contain?
SIST EN ISO 12866:2000 contains requirement clauses, detailed test methods, and tables that define how a perimeter is checked. Table 1 sets tolerances for stimulus presentation, while Tables 2 and 3 define minimum visual-field coverage and location counts.
Table 4 gives the test locations and stimulus values used for type testing, including checks at different azimuths, eccentricities, stimulus sizes, and luminance levels. The annexes provide the Goldmann stimulus references and the coordinate systems used to describe stimulus locations, which supports design, testing, and reporting.
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
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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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