SIST EN ISO 12866:2000
(Main)Ophthalmic instruments - Perimeters (ISO 12866:1999)
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
- 01-Jan-2009
- Effective Date
- 22-Dec-2008
Overview
EN ISO 12866:1999 - Ophthalmic instruments - Perimeters (ISO 12866:1999) specifies requirements and test methods for instruments that assess differential light sensitivity across the visual field by subjective detection of test stimuli on a defined background. It is a type‑testing standard for perimeters (projection and fixed‑location) and defines terms, performance tolerances, stimulus specifications (including Goldmann stimulus sets), and required documentation. The standard is intended for the instrument performance and does not prescribe clinical testing methodologies.
Key topics and technical requirements
- Scope and definitions: precise definitions for visual field concepts (central, peripheral, monocular/binocular), perimeter types (projection, fixed‑location, kinetic, static), and photometric terms (background luminance, stimulus luminance, differential luminance, threshold).
- Performance tolerances: specified tolerances for background luminance, contrast (DL/LB), stimulus location, size (converted to solid angle), shape, and duration (see Table 1 in the standard).
- Stimulus specifications: Goldmann test stimulus sizes and differential luminances are referenced (Annex A) and stimulus coordinate systems are provided (Annex B).
- Minimum coverage: required minimum eccentricities and minimum total potential stimulus locations for central, midperipheral and full‑field perimeters (Tables 2 and 3).
- Kinetic vs static perimeters: requirements for smooth and continuous stimulus movement and specification of speed/characteristics for kinetic perimeters; temporal presentation, stimulus patterns and coordinate referencing for static perimeters.
- Test methods and type tests: standardized procedures for measuring background luminance, stimulus luminance, test stimulus location, size, shape and duration (clause 5). Type testing for projection and fixed‑location perimeters requires repeated measurements at defined locations (Table 4).
- Device features and documentation: requirements for fixation monitoring, optical correction provision, head positioning, ability to quantify per‑location results, and contents of test records.
Applications and users
- Manufacturers of ophthalmic perimeters - to design, validate and document device performance to internationally accepted tolerances.
- Test laboratories and conformity assessors - to perform type testing, calibration and verification of perimeters against ISO 12866 requirements.
- Regulatory and quality teams - for device submissions, technical files and compliance with harmonized ophthalmic instrument standards.
- Clinical engineers and hospital biomedical departments - for acceptance testing, maintenance and performance verification of perimeter equipment (note: the standard does not define clinical test protocols).
Related standards
- ISO 15004:1997 - Ophthalmic instruments - fundamental requirements and test methods (ISO 12866 takes precedence where differences exist).
- IEC 60601‑1 / IEC 60601‑1‑1 - Medical electrical equipment safety standards referenced for general safety and system requirements.
Keywords: ophthalmic instruments, perimeters, ISO 12866, perimetry, visual field, Goldmann stimulus, background luminance, differential light sensitivity, static perimeter, kinetic perimeter, type testing, device calibration.
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 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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