EN ISO 21987:2017

SLOVENSKI STANDARD
01-november-2017
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SIST EN ISO 21987:2010
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Ophthalmic optics - Mounted spectacle lenses (ISO 21987:2017)
Augenoptik - Fertig montierte Korrektionsbrillengläser (ISO 21987:2017)
Optique ophtalmique - Verres ophtalmiques montés (ISO 21987:2017)
Ta slovenski standard je istoveten z: EN ISO 21987:2017
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 21987
EUROPEAN STANDARD
NORME EUROPÉENNE
August 2017
EUROPÄISCHE NORM
ICS 11.040.70 Supersedes EN ISO 21987:2009
English Version
Ophthalmic optics - Mounted spectacle lenses (ISO
21987:2017)
Optique ophtalmique - Verres ophtalmiques montés Augenoptik - Fertig montierte Korrektionsbrillengläser
(ISO 21987:2017) (ISO 21987:2017)
This European Standard was approved by CEN on 26 May 2017.

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, 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: Avenue Marnix 17, B-1000 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 21987:2017 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this document and the Essential
Requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered . 5

European foreword
This document (EN ISO 21987:2017) 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 February 2018, and conflicting national standards
shall be withdrawn at the latest by February 2018.
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 21987:2009.
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(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this
document.
The following referenced documents are indispensable for the application of this document. For
undated references, the latest edition of the referenced document (including any amendments) applies.
For dated references, only the edition cited applies. However, for any use of this standard ‘within the
meaning of Annex ZA’, the user should always check that any referenced document has not been
superseded and that its relevant contents can still be considered the generally acknowledged state-of-
art.
When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as a
normative reference to the corresponding EN standard, if available, and otherwise to the dated version
of the ISO or IEC standard, as listed below.
NOTE The way in which these referenced documents are cited in normative requirements determines the
extent (in whole or in part) to which they apply.
Table — Correlation between normative references and dated EN and ISO standards
Normative references as listed Equivalent dated standard
in Clause 2 of the ISO standard
EN ISO or IEC
ISO 7944 EN ISO 7944:1998  + AC:2009 ISO 7944:1998 + Cor.1:2009
ISO 8429 EN ISO 8429:1996 ISO 8429:1986
ISO 8598-1 EN ISO 8598-1:2014 ISO 8598-1:2014
ISO 8624 EN ISO 8624:2011 + A1:2015 ISO 8624:2011+ Amd.1:2015
ISO 8980-1 EN ISO 8980-1:2017 ISO 8980-1:2017
ISO 8980-2 EN ISO 8980-2:2017 ISO 8980-2:2017
ISO 13666 EN ISO 13666:2012 ISO 13666:2012
ISO 14889 EN ISO 14889:2013 ISO 14889:2013

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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 21987:2017 has been approved by CEN as EN ISO 21987:2017 without any modification.
Annex ZA
(informative)
Relationship between this document and the Essential Requirements of
Directive 93/42/EEC [OJ L 169] aimed to be covered
This document has been prepared under a Commission’s standardization request [M/023 concerning
the development of European Standards related to medical devices] to provide one voluntary means of
conforming to essential requirements of Council Directive 93/42/EEC of 14 June 1993 concerning
medical devices [OJ L 169].
Once this standard is cited in the Official Journal of the European Union under that Directive,
compliance with the normative 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.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Directive 93/42/EEC as amended by 2007/47/EC. This
means that risks have to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’
or ‘removed’, according to the wording of the corresponding essential requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with Essential
Requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive.
NOTE 3 This Annex ZA is based on normative references according to the table of references in the European
foreword, replacing the references in the core text.
NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this
document.
Table ZA.1 — Correspondence between this document and
Annex I of Directive 93/42/EEC [OJ L 169]
Essential Requirements Clause(s)/sub- Remarks/Notes
of Directive 93/42/EEC clause(s) of this
document
7.1 5.2, 5.3, 5.4, 5.5, 5.6 5.2 of the standard only meets the requirements
of Annex I, 7.1 of the Directive in respect of
toxicity and flammability.
5.3 of the standard only meets the requirements
of Annex I, 7.1 of the Directive in respect of
optical performance.
5.4 of the standard only meets the requirements
of Annex I, 7.1 of the Directive in respect of lens
thickness.
5.5 of the standard only meets the requirements
of Annex I, 7.1 of the Directive in respect of
positioning of the various lens segments.
5.6 of the standard only meets the requirements
of Annex I, 7.1 of the Directive in respect of the
orientation of polarizing lenses.
Essential Requirements Clause(s)/sub- Remarks/Notes
of Directive 93/42/EEC clause(s) of this
document
9.2 5.2 5.2 of the standard only meets the requirements
of Annex I, 9.2 of the Directive in respect of
mechanical strength and material ageing.
9.3 5.2 5.2 of the standard only meets the requirements
of Annex I, 9.3 of the Directive in respect of
flammability.
11.3.1 5.2 5.2 of the standard only meets the requirements
of Annex I, 11.3.1 of the Directive in respect of
transmittance.
13.1 Clause 7, Clause 9 Clause 7 of the standard only meets the
requirements of Annex I, 13.1 of the Directive in
respect of permanent or non-permanent marking.
Clause 9 of the standard only meets the
requirements of Annex I, 13.1 of the Directive in
respect of product identification.
13.3 Clause 9 Clause 9 of the standard only meets the
requirements of Annex I, 13.3 of the Directive in
respect of product trade name and manufacturer
address.
WARNING 1 — Presumption of conformity stays valid only as long as a reference to this document is
maintained in the list published in the Official Journal of the European Union. Users of this standard
should consult frequently the latest list published in the Official Journal of the European Union.
WARNING 2 — Other Union legislation may be applicable to the products falling within the scope of this
standard.
INTERNATIONAL ISO
STANDARD 21987
Second edition
2017-07
Ophthalmic optics — Mounted
spectacle lenses
Optique ophtalmique — Verres ophtalmiques montés
Reference number
ISO 21987:2017(E)
©
ISO 2017
ISO 21987:2017(E)
© ISO 2017, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
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ii © ISO 2017 – All rights reserved

ISO 21987:2017(E)
Contents Page
Foreword .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification . 3
5 Requirements . 3
5.1 Reference temperature . 3
5.2 Lenses used in manufacturing complete spectacles . 3
5.3 Optical requirements . 3
5.3.1 General. 3
5.3.2 Back vertex power . 4
5.3.3 Direction of the cylinder axis . 4
5.3.4 Addition power or variation power. 5
5.3.5 Prism imbalance (relative prism error) for mounted single-vision lenses
(excluding position-specific single-vision lenses) and multifocal lenses . 5
5.3.6 Prism imbalance (relative prism error) for position-specific single-vision
lenses and power-variation lenses . 7
5.4 Requirements for thickness . 7
5.5 Requirements for
...