SIST EN ISO 14889:2014

SLOVENSKI STANDARD
01-februar-2014
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SIST EN ISO 14889:2009
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Ophthalmic optics - Spectacle lenses - Fundamental requirements for uncut finished
lenses (ISO 14889:2013)
Augenoptik - Brillengläser - Grundlegende Anforderungen an rohkantige fertige
Brillengläser (ISO 14889:2013)
Optique ophtalmique - Verres de lunettes - Exigences fondamentales relatives aux
verres finis non détourés (ISO 14889:2013)
Ta slovenski standard je istoveten z: EN ISO 14889:2013
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 14889
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2013
ICS 11.040.70 Supersedes EN ISO 14889:2009
English Version
Ophthalmic optics - Spectacle lenses - Fundamental
requirements for uncut finished lenses (ISO 14889:2013)
Optique ophtalmique - Verres de lunettes - Exigences Augenoptik - Brillengläser - Grundlegende Anforderungen
fondamentales relatives aux verres finis non détourés (ISO an rohkantige fertige Brillengläser (ISO 14889:2013)
14889:2013)
This European Standard was approved by CEN on 7 September 2013.

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, 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

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2013 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14889:2013: E
worldwide for CEN national Members.

Contents Page
Foreword .3
Annex ZA (informative)  Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4

Foreword
This document (EN ISO 14889:2013) 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 2014, and conflicting national standards shall be withdrawn at the
latest by April 2014.
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.
This document supersedes EN ISO 14889:2009.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive.
For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document.
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, 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 the United Kingdom.
Endorsement notice
The text of ISO 14889:2013 has been approved by CEN as EN ISO 14889:2013 without any modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of
the New Approach Directive 93/42/EEC on medical devices.

Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA
regulations.
Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC

Clause(s)/sub-clause(s) Essential Requirements
Qualifying remarks/Notes
of this EN
(ERs)
4.3.1, 4.3.2, 4.4 7.1 Only in respect of toxicity and flammability.
Testing acc. to subclauses 5.2 and 5.3.
4.4 9.2 Testing acc. to subclause 5.3.
4.3.2 9.3 Testing acc. to subclause 5.2.
6.1 13.1, 13.3 ER 13.3 a) is only partly addressed in
subclause 6.1 e) of ISO 14889.

For devices intended by the manufacturer to be for dual use in accordance with Article 1(6) of
Directive 93/42 EEC the following Table ZA.2 details the relevant essential requirements of Directive
89/686/EC on Personal Protective Equipment and their corresponding clauses of this European
Standard. Table ZA.2 however, does not imply any citation in the OJEU under the PPE directive and thus
does not provide presumption of conformity for the PPE directive.

Table ZA.2 — Relevant Essential Requirements from Directive 89/686/EEC on Personal Protective
Equipment that are addressed by this European Standard (according to Article 1 (6) of amended
Directive 93/42/EEC)
Clause(s)/sub- Essential Requirements
Qualifying remarks/Notes
clause(s) of this EN (ERs) of Directive
89/686/EEC
— — General
A manufacturer may claim that his lenses in
addition of being corrective lenses be protective
lenses that provide personal eye protection to the
user.
As a matter of fact, personal eye protection can
relate to various kinds of risk, e.g. sunglare (indirect
1)
solar radiation ), radiation other than indirect solar
radiation, mechanical impact, etc.

Some of those risks call for requirements that go
beyond those for lenses the primary function of
which is correction of vision. For the purposes of
EN ISO 14889, the following applies.
— —
Corrective lenses with filter properties against
sunglare (indirect solar radiation)

In accordance with the European
Commission’s “GUIDELINES ON THE
APPLICATION OF COUNCIL DIRECTIVE
89/686/EEC OF 21 DECEMBER 1989 ON THE
APPROXIMATION OF THE LAWS OF THE
MEMBER STATES RELATING TO PERSONAL
PROTECTIVE EQUIPMENT” such lenses are
categorized as medical devices, thus falling under
Directive 93/42/EEC. Compliance with the ERs of
Directive 93/42/EEC, and of EN ISO 14889 as
detailed by the above Table ZA.1 implies that the
relevant requirements are met.
— —
Corrective lenses designed to provide protection
other than protection against sunglare (indirect
solar radiation)
Where corrective lenses are designed to provide
protection other than protection against sunglare
(indirect solar radiation), the relevant basic health
and safety requirements of Directive 89/ 686/EEC
apply.
These are not addressed in EN ISO 14889.
Refer to Directive 89/686/EEC and the relevant
European Standard(s) on personal eye protection.

WARNING — Other requirements and other EU Directives may be applicable to the product(s)
falling within the scope of this standard.

1) Indirect solar radiation implies general use for protection against solar radiation but not for direct observation of the
sun.
INTERNATIONAL ISO
STANDARD 14889
Third edition
2013-10-01
Ophthalmic optics — Spectacle
lenses — Fundamental requirements
for uncut finished lenses
Optique ophtalmique — Verres de lunettes — Exigences
fondamentales relatives aux verres finis non détourés
Reference number
ISO 14889:2013(E)
©
ISO 2013
ISO 14889:2013(E)
© ISO 2013
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ii © ISO 2013 – All rights reserved

ISO 14889:2013(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Fundamental requirements for spectacle lenses . 1
4.1 Performance . 1
4.2 Design . 1
4.3 Materials . 2
4.4 Mechanical strength . 2
4.5 Transmittance . 2
5 Test methods . 3
5.1 General . 3
5.2 Inflammability . 3
5.3 Test for mechanical strength . 3
6 Identification .
...