oSIST prEN 16917-1:2015

Ophthalmic optics - Instruments and test methods for assessing drivers' vision - Part 1: Visual acuity

This European standard applies to the minimum requirements and test methods for instruments used for assessing driver’s visual acuity in the context of the European driving licence requirements.
This standard does not apply to decision or recommendation to grant a driving licence according to the vision test results, that shall be the responsibility of a medical authority.

Augenoptik - Geräte und Prüfverfahren zur Beurteilung des Sehvermögens von Kraftffahrern - Teil 1: Sehschärfe

Diese Europäische Norm legt die Mindestanforderungen an und Prüfverfahren für Geräte fest, die zur Bestimmung der Sehschärfe von Kraftfahrern entsprechend den europäischen Führerscheinanforderungen eingesetzt werden.
Diese Norm betrifft nicht die Entscheidung oder Empfehlung über die Ausstellung eines Führerscheins aufgrund der Ergebnisse der Sehprüfung; dies muss durch eine medizinische Behörde erfolgen.

Optique ophtalmique - Instruments et méthodes d'essai pour évaluer la vision des conducteurs - Partie 1: Acuité visuelle

La présente Norme européenne s'applique aux exigences minimales et méthodes d'essai pour les instruments utilisés pour évaluer l'acuité visuelle des conducteurs dans le cadre des exigences relatives au permis de conduire européen.
Elle ne s'applique pas à la décision ou à la recommandation de délivrer un permis de conduire en fonction des résultats de l'examen de la vision, qui doit relever d'une autorité médicale.

Očesna optika - Instrumenti in preskusne metode za ocenjevanje vida voznikov - 1. del: Ostrina vida

General Information

• Status: Not Published
• Public Enquiry End Date: 29-Nov-2015
• ICS: 11.040.70 - Ophthalmic equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 98 - Abandoned project (Adopted Project)
• Start Date: 02-Feb-2017
• Due Date: 07-Feb-2017
• Completion Date: 02-Feb-2017
• Ref Project: prEN 16917-1 - Ophthalmic optics - Instruments and test methods for assessing drivers' vision - Part 1: Visual acuity

Overview

oSIST prEN 16917-1:2015 is a draft European standard developed by the Slovenski inštitut za standardizacijo (SIST). It outlines the minimum requirements and standardized test methods for instruments used to assess visual acuity for driver’s vision, specifically within the framework of European driving licence requirements. The main aim is to ensure uniformity and reliability in vision screening instruments, contributing to improved road safety across Europe.

This standard is part of a broader initiative to align testing with recent European Directives regarding drivers’ vision, supporting the application of these directives but leaving licensing decisions to relevant medical authorities.

Key Topics

• Minimum Instrument Requirements: Specifies requirements for devices used in visual acuity testing, including printed charts, chart projectors, electronic displays, and enclosed devices.

• Visual Acuity Test Methods: Details how instruments must present optotypes (such as Landolt rings) and outlines required sizes, sets, and presentations for effective vision assessment.

• Pass/Fail Criteria: Sets explicit pass/fail benchmarks-typically requiring at least 80% correct responses to meet the visual acuity threshold.

• Manufacturer Information: Requires manufacturers to supply clear instructions, safety information, and maintenance guidelines to ensure ongoing compliance.

• Marking and Labelling: Instruments must be permanently marked with manufacturer details and compliance references.

Applications

Practical uses of oSIST prEN 16917-1:2015 include:

• Vision Screening for Driving Licence Applicants: Standardizes the evaluation of visual acuity for applicants in categories such as A, B (group 1) and C, D (group 2), ensuring tests meet European requirements.

• Healthcare and Ophthalmic Clinics: Guides medical professionals in selecting compliant instruments and reliably testing patients’ vision relevant to driver safety.

• Device Manufacturing and Quality Control: Provides manufacturers with concrete technical and labelling requirements, enabling production of standardized instruments for vision assessment.

• Support for Regulatory Compliance: Assists national authorities and organizations in implementing vision screening protocols consistent with European Directives, thus enhancing road safety and public confidence.

Typical scenarios include pre-licence vision screening at certified clinics, regular screenings for professional drivers, and audits of compliance in vision assessment devices.

Related Standards

For comprehensive compliance and up-to-date practice, reference the following standards closely related to oSIST prEN 16917-1:2015:

• EN ISO 8596: Ophthalmic optics – Visual acuity testing – Standard optotype and its presentation
• EN ISO 10938: Ophthalmic instruments – Chart projectors
• EN 60601-1: Medical electrical equipment – General requirements for basic safety and essential performance

Additionally, the standard aligns with legislative requirements from:

• Commission Directive 2006/126/EC
• Commission Directive 2009/113/EC
• Commission Directive 2012/36/EU

Conclusion

oSIST prEN 16917-1:2015 ensures that instruments used to assess drivers’ visual acuity meet stringent quality and consistency standards. By supporting medical professionals, device manufacturers, and regulatory authorities, it fosters reliable vision testing in accordance with European driving licence requirements, thereby contributing directly to improved road safety and public welfare. For organizations engaged in vision screening and equipment production, adhering to this standard is essential for quality assurance and regulatory compliance in the field of ophthalmic optics and driver safety.

Standards Content (Sample)

SLOVENSKI STANDARD
01-november-2015
2þHVQDRSWLND,QVWUXPHQWLLQSUHVNXVQHPHWRGH]DRFHQMHYDQMHYLGDYR]QLNRY
GHO2VWULQDYLGD
Ophthalmic optics - Instruments and test methods for assessing drivers' vision - Part 1:
Visual acuity
Augenoptik - Geräte und Prüfverfahren zur Beurteilung des Sehvermögens von
Kraftffahrern - Teil 1: Sehschärfe
Optique ophtalmique - Instruments et méthodes d'essai pour évaluer la vision des
conducteurs - Partie 1: Acuité visuelle
Ta slovenski standard je istoveten z: prEN 16917-1
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT
EUROPEAN STANDARD
NORME EUROPÉENNE
EUROPÄISCHE NORM
September 2015
ICS 11.040.70
English Version
Ophthalmic optics - Instruments and test methods for
assessing drivers' vision - Part 1: Visual acuity
Optique ophtalmique - Instruments et méthodes Augenoptik - Geräte und Prüfverfahren zur Beurteilung
d'essai pour évaluer la vision des conducteurs - Partie des Sehvermögens von Kraftffahrern - Teil 1:
1: Acuité visuelle Sehschärfe
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee
CEN/TC 170.
If this draft becomes a European Standard, 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.

This draft European Standard was established by CEN 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a European Standard.

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 16917-1:2015 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
Introduction . 4
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 5
4 Visual acuity test requirements . 5
4.1 General . 5
4.2 Sub-set of letter size to be used for screening purpose . 6
4.3 Number of sets . 6
4.4 Number of optotype . 6
4.5 Test field and distance . 6
5 Test methods . 6
6 Information to be supplied by the manufacturer . 6
7 Marking . 7
Annex A (normative) Pass/fail criteria . 8
Annex B (informative) Recommendation for conducting the test . 9
Bibliography . 10

European foreword
This document (prEN 16917-1:2015) has been prepared by Technical Committee CEN/TC 170
“Ophthalmic optics”, the secretariat of which is held by DIN.
This document is currently submitted to the CEN Enquiry.
Introduction
Driver safety is an important concern, and one of the priority of the European community is to reduce
the number of fatal accident and more generally, to improve safety for drivers. Recently published new
European Directives about driving licence have proposed new requirements and particularly new visual
requirements for drivers to help improve safety. This European Standard will help the application of
these Directives, and more particularly proposes standard specification and test methods to control that
visual acuity of the driver reaches the minimum requirement of the Directives.
1 Scope
This European Standard applies to the minimum requirements and test methods for instruments used
for assessing driver’s visual acuity in the co
...