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)

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
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
19-Dec-2017
Due Date
23-Feb-2018
Completion Date
10-Jan-2018

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SLOVENSKI STANDARD
SIST EN ISO 14889:2014/A1:2018
01-februar-2018
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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

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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
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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.
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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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