SIST EN ISO 11978:2017/A1:2020

Ophthalmic optics - Contact lenses and contact lens care products - Labelling - Amendment 1 (ISO 11978:2017/Amd 1:2020)

Augenoptik - Kontaktlinsen und Kontaktlinsenpflegemittel - Herstellerinformationen - Änderung 1 (ISO 11978:2017/Amd 1:2020)

[No scope available]

Optique ophtalmique - Lentilles de contact et produits d'entretien des lentilles de contact - Étiquetage - Amendement 1 (ISO 11978:2017/Amd 1:2020)

Očesna optika - Kontaktne leče in izdelki za vzdrževanje kontaktnih leč - Označevanje - Dopolnilo A1 (ISO 11978:2017/Amd 1:2020)

General Information

• Status: Published
• Public Enquiry End Date: 19-Mar-2020
• Publication Date: 11-Nov-2020
• ICS: 11.040.70 - Ophthalmic equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 29-Oct-2020
• Due Date: 03-Jan-2021
• Completion Date: 12-Nov-2020
• Ref Project: EN ISO 11978:2017/A1:2020 - Ophthalmic optics - Contact lenses and contact lens care products - Labelling - Amendment 1 (ISO 11978:2017/Amd 1:2020)

Relations

• Amends: SIST EN ISO 11978:2017 - Ophthalmic optics - Contact lenses and contact lens care products - Labelling (ISO 11978:2017)
• Effective Date: 01-Dec-2020

Overview

EN ISO 11978:2017/A1:2020 - Ophthalmic optics: Contact lenses and contact lens care products - Labelling (Amendment 1) is a CEN-endorsed amendment to ISO 11978:2017. It updates labelling requirements to improve legibility and accessibility of manufacturer information on contact lenses and care-product packaging. The amendment (published October 2020) was adopted as a European Standard (EN ISO 11978:2017/A1:2020).

Key topics and technical requirements

• Minimum character/symbol size: All user-facing written information and symbols must be designed with a minimum height of 0.7 mm.
• Contrast requirements: For colour combinations other than black text on a white background, labels must achieve a contrast ratio of at least 3:1 between text/symbol colour and background.
• Colour space and conversions: Colour contrast calculations are to be performed using RGB / sRGB values. CMYK print values should be converted to RGB using a suitable conversion tool.
• Contrast computation method: Annex A (informative) defines the calculation workflow:
  • Normalize 8‑bit RGB values to sRGB, apply nonlinear linearization (threshold ~0.04045 and gamma ≈2.4).
  • Compute relative luminance using IEC coefficients (L = 0.2126·R + 0.7152·G + 0.0722·B in linear sRGB).
  • Calculate contrast as (L1 + 0.05) / (L2 + 0.05), where L1 is the lighter luminance. Black on white has a maximum contrast of 21:1.
• Guidance and examples: Annex A includes worked examples of acceptable and unacceptable colour combinations and references standards/guidelines such as IEC 61966-2-1 and WCAG 2.1.

Applications and who should use it

• Contact lens and care-product manufacturers - to ensure packaging and instructions meet legibility and accessibility requirements for market access in CEN countries.
• Regulatory and compliance teams - to verify label conformity during product approval and audits.
• Packaging designers and print vendors - to select colour schemes, fonts and print processes that meet the 0.7 mm size and 3:1 contrast constraint after CMYK-to-RGB conversion.
• Quality assurance and testing labs - to perform contrast measurements and provide evidence of compliance.
• Optical retailers and healthcare providers - to understand label standards for patient safety and product information clarity.

Related standards

• IEC 61966-2-1 (sRGB / colour management)
• WCAG 2.1 (Web Content Accessibility Guidelines) - referenced for contrast methodology and accessibility principles
• CIE 1931 (colour spaces / tristimulus values)

Keywords: EN ISO 11978, contact lens labelling, ophthalmic optics standard, label contrast ratio, sRGB contrast calculation, CMYK to RGB conversion, packaging compliance, accessibility.

Standards Content (Sample)

SLOVENSKI STANDARD
01-december-2020
Očesna optika - Kontaktne leče in izdelki za vzdrževanje kontaktnih leč -
Označevanje - Dopolnilo A1 (ISO 11978:2017/Amd 1:2020)
Ophthalmic optics - Contact lenses and contact lens care products - Labelling -
Amendment 1 (ISO 11978:2017/Amd 1:2020)
Augenoptik - Kontaktlinsen und Kontaktlinsenpflegemittel - Herstellerinformationen -
Änderung 1 (ISO 11978:2017/Amd 1:2020)
Optique ophtalmique - Lentilles de contact et produits d'entretien des lentilles de contact
- Étiquetage - Amendement 1 (ISO 11978:2017/Amd 1:2020)
Ta slovenski standard je istoveten z: EN ISO 11978:2017/A1:2020
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 11978:2017/A1
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2020
EUROPÄISCHE NORM
ICS 11.040.70
English Version
Ophthalmic optics - Contact lenses and contact lens care
products - Labelling - Amendment 1 (ISO
11978:2017/Amd 1:2020)
Optique ophtalmique - Lentilles de contact et produits Augenoptik - Kontaktlinsen und
d'entretien des lentilles de contact - Étiquetage - Kontaktlinsenpflegemittel - Herstellerinformationen -
Amendement 1 (ISO 11978:2017/Amd 1:2020) Änderung 1 (ISO 11978:2017/Amd 1:2020)
This amendment A1 modifies the European Standard EN ISO 11978:2017; it was approved by CEN on 12 October 2020.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of
this amendment into the relevant 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 amendment 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
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11978:2017/A1:2020 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 11978:2017/A1:2020) 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 April 2021, and conflicting national standards shall be
withdrawn at the latest by April 2021.
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.
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 11978:2017/Amd 1:2020 has been approved by CEN as EN ISO 11978:2017/A1:2020
without any modification.
INTERNATIONAL ISO
STANDARD 11978
Third edition
2017-08
AMENDMENT 1
2020-10
Ophthalmic optics — Contact lenses
and contact lens care products —
Labelling
AMENDMENT 1
Optique ophtalmique — Lentilles de contact et produits d'entretien
des lentilles de contact — Étiquetage
AMENDEMENT 1
Reference number
ISO 11978:2017/Amd.1:2020(E)
©
ISO 2020
ISO 11978:2017/Amd.1:2020(E)
© ISO 2020
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 2020 – All rights reserved

ISO 11978:2017/Amd.1:2020(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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
a
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