EN ISO 12870:2012
(Main)Ophthalmic optics - Spectacle frames - Requirements and test methods (ISO 12870:2012)
Ophthalmic optics - Spectacle frames - Requirements and test methods (ISO 12870:2012)
2011-04-12 EMA: draft for // final vote received in ISO/CS (see notification of 2011-04-12 in dataservice).
Augenoptik - Brillenfassungen - Anforderungen und Prüfverfahren (ISO 12870:2012)
Diese Internationale Norm legt grundlegende Anforderungen für unverglaste Brillenfassungen fest, die zur Ver¬wendung mit allen Korrektionsgläsern bestimmt sind. Sie ist zum Zeitpunkt des Verkaufs der Brillen-fassung durch den Hersteller oder Lieferant an den Wiederverkäufer gültig.
Diese Internationale Norm gilt für alle Brillenfassungsarten, einschließlich randloser, halb-randloser und zusammen¬klappbarer Brillen¬fassungen. Sie gilt auch für Brillenfassungen aus natür¬lichen organischen Materialien.
ANMERKUNG Empfehlungen bezüglich der Konstruktion von Brillenfassungen siehe Anhang A.
Diese Internationale Norm gilt nicht für als Sonderanfertigung hergestellte Brillenfassungen und für Produkte, die speziell für den persönlichen Augenschutz bestimmt sind.
Optique ophtalmique - Montures de lunettes - Exigences et méthodes d'essai (ISO 12870:2012)
Očesna optika - Okviri očal - Zahteve in preskusne metode (ISO 12870:2012)
Ta mednarodni standard določa temeljne zahteve glede nezastekljenih okvirov očal, ki se lahko uporabljajo z vsemi lečami na recept. Velja za okvire na prodajnem mestu proizvajalca ali dobavitelja prodajalcu na drobno. Ta mednarodni standard velja za vse vrste okvirov očal, vključno z očali brez okvira, očali s polovičnim okvirom in zložljive okvire očal. Prav tako velja za okvire očal, narejene iz naravnih organskih materialov.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2012
1DGRPHãþD
SIST EN ISO 12870:2009
2þHVQDRSWLND2NYLULRþDO=DKWHYHLQSUHVNXVQHPHWRGH ,62
Ophthalmic optics - Spectacle frames - Requirements and test methods (ISO
12870:2012)
Augenoptik - Brillenfassungen - Anforderungen und Prüfverfahren (ISO 12870:2012)
Optique ophtalmique - Montures de lunettes - Exigences et méthodes d'essai (ISO
12870:2012)
Ta slovenski standard je istoveten z: EN ISO 12870:2012
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 12870
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2012
ICS 11.040.70 Supersedes EN ISO 12870:2009
English Version
Ophthalmic optics - Spectacle frames - Requirements and test
methods (ISO 12870:2012)
Optique ophtalmique - Montures de lunettes - Exigences et Augenoptik - Brillenfassungen - Anforderungen und
méthodes d'essai (ISO 12870:2012) Prüfverfahren (ISO 12870:2012)
This European Standard was approved by CEN on 23 March 2012.
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, 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 12870:2012: E
worldwide for CEN national Members.
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EC Directive 93/42/EEC .4
Foreword
This document (EN ISO 12870:2012) 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 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 October 2012, and conflicting national standards shall be withdrawn at
the latest by October 2012.
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 12870:2009.
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, 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 12870:2012 has been approved by CEN as a EN ISO 12870:2012 without any modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EC 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
Clauses/subclauses Essential Requirements (ERs)
Qualifying remarks/notes
of this European Standard of Directive 93/42/EEC
4.1, 4.2, 4.5, 4.6, 4,7, 4.8, 1 The requirements declared as optional in Table 1,
a
4.9, 9, 10 but cited in the list given in footnote , only provide
presumption of conformity to their corresponding
Essential Requirements if they are complied with.
See below in the present table.
4.1, 4.2, 4.5, 4.6, 4,7, 4.8, 2 The requirements declared as optional in Table 1,
a
4.9, 9, 10 but cited in the list given in footnote , only provide
presumption of conformity to their corresponding
Essential Requirements if they are complied with.
See below in the present table.
4 3 Testing in accordance with Clauses 5, 6, 7 and 8.
4.6 to 4.9 4 Testing in accordance with 8.2 to 8.6.
4.2.1, 4.2.2, 4.2.3 6 Testing in accordance with 8.8.
The requirement of 4.2.3 (i.e. 0,5 µg/cm /week) is
the requirement set forth by Directive 94/27/EEC.
The test in 8.8 makes reference to EN 16128 and
EN 12472. See also explanations in Annex D.
4.2.4 6 a) ―
4.2.1, 4.2.2, 4.2.3 7.1 Testing in accordance with 8.8.
The requirement of 4.2.3 (i.e. 0,5 µg/cm /week) is
the requirement set forth by Directive 94/27/EEC.
The test in 8.8 makes reference to EN 16128 and
EN 12472. See also explanations in Annex D.
4.6 to 4.9 7.1 Testing in accordance with 8.2 to 8.6.
Table ZA.1 (end)
Clauses/subclauses Essential Requirements (ERs)
Qualifying remarks/notes
of this European Standard of Directive 93/42/EEC
4.2.1, 4.2.2, 4.2.3 7.2 Testing in accordance with 8.8.
The requirement of 4.2.3 (i.e. 0,5 µg/cm /week) is
the requirement set forth by Directive 94/27/EEC.
The test in 8.8 makes reference to EN 16128 and
EN 12472. See also explanations in Annex D.
4.6 to 4.9 7.3 Testing in accordance with 8.2 to 8.6.
4.2.2, 4.2.3 7.5 Testing in accordance with 8.8.
Essential Requirement 7.5 is only partly addressed
in ISO 12870. To the extent that it is covered in
ISO 12870, testing is carried out in accordance
with 8.8.
The requirement of 4.2.3 (i.e. 0,5 µg/cm /week) is
the requirement set forth by Directive 94/27/EEC.
The test in 8.8 makes reference to EN 16128 and
EN 12472. See also explanations in Annex D.
4.8 9.1 Testing in accordance with 8.4 and 8.5.
4.9 9.3 Testing in accordance with 8.6.
9, 10 13.1 ―
9, 10 13.3 The statement in 10.4 is true for the countries of
the Community [cf. ER 13.3 a)].
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.
INTERNATIONAL ISO
STANDARD 12870
Third edition
2012-04-01
Ophthalmic optics — Spectacle frames —
Requirements and test methods
Optique ophtalmique — Montures de lunettes — Exigences et
méthodes d’essai
Reference number
ISO 12870:2012(E)
©
ISO 2012
ISO 12870:2012(E)
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electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO’s
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ii © ISO 2012 – All rights reserved
ISO 12870:2012(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 2
4.1 General . 2
4.2 Physiological compatibility . 3
4.3 Measurement system . 4
4.4 Dimensional tolerances on nominal size . 4
4.5 Tolerance on screw threads . 4
4.6 Dimensional stability at elevated temperature . 4
4.7 Resistance to perspiration . 4
4.8 Mechanical stability . 5
4.9 Resistance to ignition . 6
4.10 Resistance to optical radiation . 6
5 Selection of test samples . 6
5.1 General . 6
5.2 Testing for nickel release . 6
5.3 Change in spectacle frame model . 6
6 Preparation and conditioning of test samples . 6
6.1 Test lenses . 6
6.2 Sample conditioning and test conditions . 7
7 Testing, inspection and compliance . 7
7.1 Testing . 7
7.2 Inspection and examination . 8
7.3 Compliance . 8
8 Test methods . 9
8.1 General . 9
8.2 Test for dimensional stability at elevated temperature . 9
8.3 Test for resistance to perspiration .10
8.4 Bridge deformation and lens retention test . 11
8.5 Endurance test .
...
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