EN ISO 11979-4:2008/A1:2012
(Amendment)Ophthalmic implants - Intraocular lenses - Part 4: Labelling and information - Amendment 1 (ISO 11979-4:2008/Amd 1:2012)
Ophthalmic implants - Intraocular lenses - Part 4: Labelling and information - Amendment 1 (ISO 11979-4:2008/Amd 1:2012)
2012-03-28 EMA: Draft for // vote received in ISO/CS (see notification of 2012-03-27 in dataservice).
2011-05-31 EMA: Draft for // ENQ received in ISO/CS (see notification of 2011-05-30 in dataservice).
Ophthalmische Implantate - Intraokularlinsen - Teil 4: Etikettierung und Information - Änderung 1 (ISO 11979-4:2008/Amd 1:2012)
Implants ophtalmiques - Lentilles intraoculaires - Partie 4: Étiquetage et informations - Amendement 1 (ISO 11979-4:2008/Amd 1:2012)
Očesni vsadki (implantati) - Intraokularne leče - 4. del: Označevanje in informacije - Dopolnilo A1 (ISO 11979-4:2008/Amd 1:2012)
Ta del standarda ISO 11979 določa zahteve za označevanje intraokularnih leč (IOL) in informacije, ki morajo biti priložene embalaži ali biti natisnjene na embalaži.
General Information
- Status
- Published
- Publication Date
- 30-Sep-2012
- Withdrawal Date
- 29-Apr-2013
- 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
- 01-Oct-2012
- Completion Date
- 01-Oct-2012
Relations
- Effective Date
- 06-Mar-2010
- Effective Date
- 19-Jan-2023
Overview
EN ISO 11979-4:2008/A1:2012 is Amendment 1 to the international/European standard for ophthalmic implants - intraocular lenses (IOLs) - Part 4: Labelling and information. Published and approved by CEN in 2012, this amendment updates labelling requirements for IOLs with specific attention to toric intraocular lenses and clarifies how UV-blocking claims must be presented. The amendment is intended for consistent, safety-oriented labelling across EU member bodies and ISO members.
Key topics and requirements
- Scope of the amendment
- Modifies EN ISO 11979-4:2008 (labelling and information for IOLs).
- Approved by CEN on 29 August 2012; national adoption required by April 2013.
- Toric IOL labelling (additions to Table 2, Clause 5)
- Item 21: For toric IOLs, the label/primary package should include sphere, cylinder and axis (in + or − cylinder notation). Optionally, the spherical equivalent (SE) and absolute cylinder power (CYL) may be given.
- Item 22: For toric IOLs, the label should show orientation of the meridian of lowest positive power or most negative power as depicted in the lens drawing.
- UV-blocking information (new Clause 9)
- Any claim of UV blocking must be accompanied by the 10% cut-off wavelength expressed in nanometres (nm).
- Administrative edits
- Removal of a normative reference (ISO 11979-9:2006) and renumbering of clause list items to reflect deletions.
Practical applications
- IOL manufacturers: Update product labels, packaging inserts and primary container markings for toric lenses to comply with the added data fields and meridian orientation depiction.
- Regulatory affairs and quality teams: Use the amendment to ensure marketing and technical documentation meet European/ISO labelling expectations for clinical use and conformity assessment.
- Notified bodies and regulators: Evaluate labelling for compliance during conformity assessments and approvals.
- Clinicians and surgical teams: Benefit from clearer toric IOL labeling that supports correct lens selection and orientation in surgical planning.
- Distributors and purchasing: Ensure package information conveys power, axis, and UV protection details necessary for inventory and safe handling.
Related standards and notes
- This amendment is part of the ISO 11979 series on intraocular lenses (ophthalmic implants). It specifically amends Part 4 (labelling). Stakeholders should refer to the full EN ISO 11979-4:2008 text and national adoptions for complete labelling tables and implementation timelines.
Keywords: intraocular lenses, ophthalmic implants, labelling, toric intraocular lenses, ISO 11979-4 amendment, UV blocking, 10% cut-off wavelength, medical device labeling, IOL manufacturers, regulatory compliance.
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Frequently Asked Questions
EN ISO 11979-4:2008/A1:2012 is a amendment published by the European Committee for Standardization (CEN). Its full title is "Ophthalmic implants - Intraocular lenses - Part 4: Labelling and information - Amendment 1 (ISO 11979-4:2008/Amd 1:2012)". This standard covers: 2012-03-28 EMA: Draft for // vote received in ISO/CS (see notification of 2012-03-27 in dataservice). 2011-05-31 EMA: Draft for // ENQ received in ISO/CS (see notification of 2011-05-30 in dataservice).
2012-03-28 EMA: Draft for // vote received in ISO/CS (see notification of 2012-03-27 in dataservice). 2011-05-31 EMA: Draft for // ENQ received in ISO/CS (see notification of 2011-05-30 in dataservice).
EN ISO 11979-4:2008/A1:2012 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.
EN ISO 11979-4:2008/A1:2012 has the following relationships with other standards: It is inter standard links to EN ISO 11979-4:2008, FprEN ISO 11979-4. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 11979-4:2008/A1:2012 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
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Ophthalmic implants - Intraocular lenses - Part 4: Labelling and information - Amendment
1 (ISO 11979-4:2008/Amd 1:2012)
Ophthalmische Implantate - Intraokularlinsen - Teil 4: Etikettierung und Information -
Änderung 1 (ISO 11979-4:2008/Amd 1:2012)
Implants ophtalmiques - Lentilles intraoculaires - Partie 4: Étiquetage et informations -
Amendement 1 (ISO 11979-4:2008/Amd 1:2012)
Ta slovenski standard je istoveten z: EN ISO 11979-4:2008/A1:2012
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 11979-4:2008/A1
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2012
ICS 11.040.70
English Version
Ophthalmic implants - Intraocular lenses - Part 4: Labelling and
information - Amendment 1 (ISO 11979-4:2008/Amd 1:2012)
Implants ophtalmiques - Lentilles intraoculaires - Partie 4: Ophthalmische Implantate - Intraokularlinsen - Teil 4:
Étiquetage et informations - Amendement 1 (ISO 11979- Etikettierung und Information - Änderung 1 (ISO 11979-
4:2008/Amd 1:2012) 4:2008/Amd 1:2012)
This amendment A1 modifies the European Standard EN ISO 11979-4:2008; it was approved by CEN on 29 August 2012.
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, 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.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11979-4:2008/A1:2012: E
worldwide for CEN national Members.
Contents Page
Foreword .3
Foreword
This document (EN ISO 11979-4:2008/A1:2012) 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 Amendment to the European Standard EN ISO 11979:2008 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by April 2013, and
conflicting national standards shall be withdrawn at the latest by April 2013.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
According to the CEN/CENELEC Internal Regulations, the national standards organisations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of
...
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