EN ISO 15253:2021

Ophthalmic optics and instruments - Optical and electro-optical devices for enhancing low vision (ISO 15253:2021)

This document is applicable to optical and electro-optical devices specified by the manufacturer for use by visually impaired persons as low vision aids. This document specifies requirements and test methods for optical and electro-optical devices specified by the manufacturer for use by visually impaired persons as low vision devices.
Implantable low vision devices are excluded.

Augenoptik und ophthalmische Instrumente - Optische und elektrooptische vergrößernde Sehhilfen für Sehbehinderte (ISO 15253:2021)

Dieses Dokument ist anwendbar für optische und elektrooptische Geräte, die vom Hersteller für die Ver¬wendung durch sehbehinderte Personen als Sehhilfen vorgesehen sind. Dieses Dokument legt Anforderungen und Prüfverfahren für optische und elektrooptische Geräte fest, die vom Hersteller für die Verwendung durch sehbehinderte Personen als Sehhilfen vorgesehen sind.
Implantierbare Sehhilfen sind ausgenommen.

Optique et instruments ophtalmiques - Dispositifs optiques et électro-optiques pour malvoyants (ISO 15253:2021)

Le présent document est applicable aux dispositifs optiques et électro-optiques destinés, selon les indications du fabricant, à être utilisés par des personnes malvoyantes comme systèmes d'aide à la vision. Le présent document spécifie les exigences et les méthodes d'essai applicables aux dispositifs optiques et électro-optiques conçus par le fabricant pour servir d'aides à la vision chez les personnes malvoyantes.
Il ne concerne pas les implants oculaires.

Očesna optika in instrumenti - Optične in elektrooptične naprave za izboljšanje slabovidnosti (ISO 15253:2021)

General Information

• Status: Published
• Publication Date: 13-Jul-2021
• Withdrawal Date: 30-Jan-2022
• 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: 14-Jul-2021
• Completion Date: 14-Jul-2021
• Ref Project: SIST EN ISO 15253:2021 - Ophthalmic optics and instruments - Optical and electro-optical devices for enhancing low vision (ISO 15253:2021)

Relations

• Replaces: EN ISO 15253:2000/AC:2001 - Ophthalmic optics and instruments - Optical devices for enhancing low vision (ISO 15253:2000)
• Effective Date: 21-Jul-2021
• Replaces: EN ISO 15254:2009 - Ophthalmic optics and instruments - Electro-optical devices for enhancing low vision (ISO 15254:2009)
• Effective Date: 21-Jul-2021
• Replaces: EN ISO 15253:2000 - Ophthalmic optics and instruments - Optical devices for enhancing low vision (ISO 15253:2000)
• Effective Date: 04-Dec-2019

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2021
Nadomešča:
SIST EN ISO 15253:2001
SIST EN ISO 15253:2001/AC:2001
SIST EN ISO 15254:2009
Očesna optika in instrumenti - Optične in elektrooptične naprave za izboljšanje
slabovidnosti (ISO 15253:2021)
Ophthalmic optics and instruments - Optical and electro-optical devices for enhancing
low vision (ISO 15253:2021)
Augenoptik und ophthalmische Instrumente - Optische und elektrooptische vergrößernde
Sehhilfen für Sehbehinderte (ISO 15253:2021)
Optique et instruments ophtalmiques - Dispositifs optiques et électro-optiques pour
malvoyants (ISO 15253:2021)
Ta slovenski standard je istoveten z: EN ISO 15253:2021
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 15253
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2021
EUROPÄISCHE NORM
ICS 11.040.70 Supersedes EN ISO 15253:2000, EN ISO
15253:2000/AC:2001, EN ISO 15254:2009
English Version
Ophthalmic optics and instruments - Optical and electro-
optical devices for enhancing low vision (ISO 15253:2021)
Optique et instruments ophtalmiques - Dispositifs Augenoptik und ophthalmische Instrumente - Optische
optiques et électro-optiques pour malvoyants (ISO und elektrooptische vergrößernde Sehhilfen für
15253:2021) Sehbehinderte (ISO 15253:2021)
This European Standard was approved by CEN on 28 June 2021.

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-CENELEC 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-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15253:2021 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 15253:2021) 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 January 2022, and conflicting national standards shall
be withdrawn at the latest by January 2022.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 15253:2000, EN ISO 15253:2000/AC:2001 and EN ISO 15254:2009.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN websites.
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,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 15253:2021 has been approved by CEN as EN ISO 15253:2021 without any modification.

INTERNATIONAL ISO
STANDARD 15253
Second edition
2021-06
Ophthalmic optics and instruments —
Optical and electro-optical devices for
enhancing low vision
Optique et instruments ophtalmiques — Dispositifs optiques et
électro-optiques pour malvoyants
Reference number
ISO 15253:2021(E)
©
ISO 2021
ISO 15253:2021(E)
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved

ISO 15253:2021(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification . 9
4.1 Optical devices . 9
4.1.1 Distance vision . . 9
4.1.2 Near and intermediate vision . 9
4.1.3 Retinal illumination reduction or contrast enhancement . 9
4.2 Electro-optical devices . 9
5 Requirements . 9
5.1 General . 9
5.1.1 Risk assessment and management . 9
5.1.2 Materials . 9
5.1.3 Dimensions and weight . 9
5.1.4 Flammability/Ignitability.10
5.1.5 Resistance to perspiration .10
5.1.6 Robustness .10
5.1.7 Resistance to drop .10
5.2 Optical devices .10
5.2.1 Spatial resolution .10
5.2.2 Equivalent power (applies to optical devices designed for near or
intermediate use) .10
5.2.3 Magnification .11
5.2.4 Exit image distance (applies to stand magnifiers) .11
5.2.5 Entrance pupil diameter (applies to telescopes) .12
5.2.6 Transmittance .12
5.2.7 Image relocation .12
5.3 Electro-optical devices .12
5.3.1 Display size .12
5.3.2 Ambient temperatures . . .12
5.3.3 Image characteristics .12
5.3.4 Object (XY) table .13
5.3.5 Electro-optical device working distance .13
5.3.6 Text to speech system .13
5.3.7 Electrical requirements .13
6 Test methods .13
6.1 General .13
6.2 Optical devices .14
6.2.1 Spatial resolution test .14
6.2.2 Equivalent power – Magnifiers .18
6.2.3 Angular magnification – Telescopes .18
6.2.4 Transverse magnification – Stand magnifiers .18
6.2.5 Lateral variation of magnification test .18
6.2.6 Exit image distance – Stand magnifiers .18
6.3 Electro-optical devices .18
6.3.1 Displ
...