SIST EN ISO 14889:2014/A1:2018

Ophthalmic optics - Spectacle lenses - Fundamental requirements for uncut finished lenses - Amendment 1 (ISO 14889:2013/Amd 1:2017)

2022-03-06-JO-waiting for assessment at PUB

Augenoptik - Brillengläser - Grundlegende Anforderungen an rohkantige fertige Brillengläser - Änderung 1 (ISO 14889:2013/Amd 1:2017)

Optique ophtalmique - Verres de lunettes - Exigences fondamentales relatives aux verres finis non détourés - Amendement 1 (ISO 14889:2013/Amd 1:2017)

Očesna optika - Stekla očal - Temeljne zahteve za nebrušena gotova stekla - Dopolnilo A1 (ISO 14889:2013/Amd 1:2017)

General Information

• Status: Published
• Public Enquiry End Date: 09-May-2017
• Publication Date: 09-Jan-2018
• ICS: 11.040.70 - Ophthalmic equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 19-Dec-2017
• Due Date: 23-Feb-2018
• Completion Date: 10-Jan-2018
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN ISO 14889:2013/A1:2017 - Ophthalmic optics - Spectacle lenses - Fundamental requirements for uncut finished lenses (ISO 14889:2013)

Relations

• Amends: SIST EN ISO 14889:2014 - Ophthalmic optics - Spectacle lenses - Fundamental requirements for uncut finished lenses (ISO 14889:2013)
• Effective Date: 01-Feb-2018

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 14889:2014/A1:2018
01-februar-2018
2þHVQDRSWLND6WHNODRþDO7HPHOMQH]DKWHYH]DQHEUXãHQDJRWRYDVWHNOD
'RSROQLOR$,62$PG
Ophthalmic optics - Spectacle lenses - Fundamental requirements for uncut finished
lenses - Amendment 1 (ISO 14889:2013/Amd 1:2017)
Augenoptik - Brillengläser - Grundlegende Anforderungen an rohkantige fertige
Brillengläser - Änderung 1 (ISO 14889:2013/Amd 1:2017)
Optique ophtalmique - Verres de lunettes - Exigences fondamentales relatives aux
verres finis non détourés - Amendement 1 (ISO 14889:2013/Amd 1:2017)
Ta slovenski standard je istoveten z: EN ISO 14889:2013/A1:2017
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 14889:2014/A1:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 14889:2014/A1:2018

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SIST EN ISO 14889:2014/A1:2018


EN ISO 14889:2013/A1
EUROPEAN STANDARD

NORME EUROPÉENNE

December 2017
EUROPÄISCHE NORM
ICS 11.040.70
English Version

Ophthalmic optics - Spectacle lenses - Fundamental
requirements for uncut finished lenses - Amendment 1
(ISO 14889:2013/Amd 1:2017)
Optique ophtalmique - Verres de lunettes - Exigences Augenoptik - Brillengläser - Grundlegende
fondamentales relatives aux verres finis non détourés - Anforderungen an rohkantige fertige Brillengläser -
Amendement 1 (ISO 14889:2013/Amd 1:2017) Änderung 1 (ISO 14889:2013/Amd 1:2017)
This amendment A1 modifies the European Standard EN ISO 14889:2013; it was approved by CEN on 5 December 2017.

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, 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
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14889:2013/A1:2017 E
worldwide for CEN national Members.

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SIST EN ISO 14889:2014/A1:2018
EN ISO 14889:2013/A1:2017 (E)
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC [OJ L 169] aimed to be covered . 5

2

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SIST EN ISO 14889:2014/A1:2018
EN ISO 14889:2013/A1:2017 (E)
European foreword
This document (EN ISO 14889:2013/A1:2017) 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 Amendment to the European Standard EN ISO 14889:2013 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by June 2018, and
conflicting national standards shall be withdrawn at the latest by June 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 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 documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies.
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 Equivalent dated standard
listed in Clause 2 of the ISO
EN ISO or IEC
standard
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 8980-3 EN ISO 8980-3:2013 ISO 8980-3:2013
ISO 8980-4 EN ISO 8980-4:2006 ISO 8980-4:2006
ISO 13666 EN ISO 13666:2012 ISO 13666:2012
3

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SIST EN ISO 14889:2014/A1:2018
EN ISO 14889:2013/A1:2017 (E)
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 14889:2013/Amd 1:2017 has been approved by CEN as EN ISO 14889:2013/A1:2017
without any modification.
4

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SIST EN ISO 14889:2014/A1:2018
EN ISO 14889:2013/A1:2017 (E)
Annex ZA
(informative)

Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC [OJ L 169] aimed to be covered
This European Standard 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
European Standard.
Table ZA.1 — Correspondence between this European Standard and Annex I of Directive
93/42/EEC [OJ L 169]
Essential Requirements Clause(s)/subclause(s) of
Remarks/Notes
of directive 93/42/EEC this EN
7.1 4.3.1, 4.3.2, 5.2 4.3.2 and 5.2 of the standard only meet
the requirements of Annex I, ER 7.1
first dash of the Directive in respect of
flammability.
4.3.1 of the standard only meets the
requirements of Annex I, ER 7.1
second dash of the Directive in respect
of physiological compatibility.
Annex I, ER 7.1 third dash of the
Directive is not covered.
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SIST EN ISO 14889:2014/A1:2018
EN ISO 14889:2013/A1:2017 (E)
Essential Re
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