EN ISO 12870:2018
(Main)Ophthalmic optics - Spectacle frames - Requirements and test methods (ISO 12870:2016)
Ophthalmic optics - Spectacle frames - Requirements and test methods (ISO 12870:2016)
ISO 12870:2016 specifies fundamental requirements for unglazed spectacle frames designed for use with all prescription lenses. It is applicable to frames at the point of sale by the manufacturer or supplier to the retailer.
This International Standard is applicable to all spectacle frame types, including rimless mounts, semi-rimless mounts and folding spectacle frames. It is also applicable to spectacle frames made from natural organic materials.
NOTE See Annex A for recommendations on the design of spectacle frames.
ISO 12870:2016 is not applicable to complete custom-made spectacle frames or to products designed specifically to provide personal eye protection.
Augenoptik - Brillenfassungen - Anforderungen und Prüfverfahren (ISO 12870:2016)
Diese Internationale Norm legt grundlegende Anforderungen für unverglaste Brillenfassungen fest, die zur Verwendung 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 zusammenklappbarer Brillenfassungen. Sie gilt auch für Brillenfassungen aus natürlichen 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 12870:2016)
ISO 12870:2016 spécifie les exigences fondamentales relatives aux montures de lunettes dépourvues de verres conçues pour être équipées de tous les verres de spécification. Elle s'applique au point de vente chez le détaillant, par le fabricant ou le fournisseur.
La présente Norme internationale s'applique à tous les types de monture, y compris les montures percées, les montures demi-cerclées et les montures pliables. La présente Norme internationale est également applicable aux montures de lunettes fabriquées à partir de substances organiques naturelles.
NOTE Voir l'Annexe A pour ce qui concerne les recommandations relatives à la conception des montures de lunettes.
ISO 12870:2016 ne s'applique ni aux montures complètes fabriquées sur mesure ni aux produits spécifiquement conçus pour assurer une protection individuelle de l'?il.
Očesna optika - Okviri očal - Zahteve in preskusne metode (ISO 12870:2016)
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.
OPOMBA: Za priporočila o zasnovi okvirov očal glejte Prilogo A.
Ta mednarodni standard se ne uporablja za okvire očal, v celoti izdelanih po meri, ali za izdelke, ki so posebej zasnovani za osebno varovanje oči.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2018
1DGRPHãþD
SIST EN ISO 12870:2015
2þHVQDRSWLND2NYLULRþDO=DKWHYHLQSUHVNXVQHPHWRGH ,62
Ophthalmic optics - Spectacle frames - Requirements and test methods (ISO
12870:2016)
Augenoptik - Brillenfassungen - Anforderungen und Prüfverfahren (ISO 12870:2016)
Optique ophtalmique - Montures de lunettes - Exigences et méthodes d'essai (ISO
12870:2016)
Ta slovenski standard je istoveten z: EN ISO 12870:2018
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 12870
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2018
EUROPÄISCHE NORM
ICS 11.040.70 Supersedes EN ISO 12870:2014
English Version
Ophthalmic optics - Spectacle frames - Requirements and
test methods (ISO 12870:2016)
Optique ophtalmique - Montures de lunettes - Augenoptik - Brillenfassungen - Anforderungen und
Exigences et méthodes d'essai (ISO 12870:2016) Prüfverfahren (ISO 12870:2016)
This European Standard was approved by CEN on 26 April 2018.
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: Rue de la Science 23, B-1040 Brussels
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 12870:2018 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered . 5
European foreword
The text of ISO 12870:2016 has been prepared by Technical Committee ISO/TC 172 “Optics and
photonics” of the International Organization for Standardization (ISO) and has been taken over as
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 November 2018, and conflicting national standards
shall be withdrawn at the latest by November 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 12870:2014.
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.
Endorsement notice
The text of ISO 12870:2016 has been approved by CEN as EN ISO 12870:2018 without any modification.
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 Equivalent dated standard
as listed in Clause 2 of the
EN ISO
ISO standard
ISO 105-A02 — ISO 105-A02:1993 + Cor.1:1997
+ Cor.2:2005
ISO 105-B02 EN ISO 105-B02:2014 ISO 105-B02:2014
ISO 3696 EN ISO 3696:1995 ISO 3696:1987
Normative references Equivalent dated standard
as listed in Clause 2 of the
EN ISO
ISO standard
ISO 7998 EN ISO 7998:2005 ISO 7998:2005
ISO 8596 EN ISO 8596:2018 ISO 8596:2017
ISO 8624:2011 EN ISO 8624:2011 + A1:2015 ISO 8624:2011 + Amd.1:2015
ISO 11380 EN ISO 11380:1996 ISO 11380:1994
ISO 11381 EN ISO 11381:2016 ISO 11381:2016
ISO/TS 24348:2014 a ISO/TS 24348:2014
EN 16128:2011
a
Note that EN 16128 has recently been revised and its most recent edition is now 2015. ISO/TS 24348:2014
will be amended to align with the text of EN 16128:2015.
Annex ZA
(informative)
Relationship between this European Standard and the essential
requirements of 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)/sub-clause(s) Remarks/Notes
of Directive 93/42/EEC of this EN
7.2 4.2.2, 4.2.3 This ER is covered only for certain specific
aspects and substances which are
mentioned in the indicated paragraphs.
This ER is covered in respect of substances
migrating to the wearer only.
The requirement of 4.2.3 is the requirement
set forth by Entry 27 of Annex XVII to
REACH. With respect to testing 4.2.3 makes
reference to EN 16128. See also
explanations in Annex C.
7.3 4.6, 4.7, 4.8 Only the first part of this ER applies to
spectacle frames, and this is covered only
for certain specific aspects which are
mentioned in the indicated paragraphs.
Essential Requirements Clause(s)/sub-clause(s) Remarks/Notes
of Directive 93/42/EEC of this EN
7.5 4.2.2, 4.2.3, 4.2.4, 4.7, 4.9 1st paragraph of ER 7.5 is partially covered
by the overall but not specific guidance in
subclause 4.2.2.
Specific guidance is given for nickel, in
subclause 4.2.3. The requirement of 4.2.3
(i.e. 0,5 μg/cm /week) is the requirement
set forth by Entry 27 of Annex XVII to
REACH.
With respect to testing 4.2.3 makes
reference to EN 16128. See also
explanations in Annex C.
2nd and 3rd paragraph of ER 7.5 are not
applicable to spectacle frames.
9.1 4.8 Only the first sentence of ER 9.1 is covered.
9.2 4.2.1, 4.6 From the 1st bullet point of ER 9.2, the
dimensional and ergonomic features are
applicable to spectacle frames and are
covered by 4.2.1. Volume/pressure ratio is
not applicable to spectacle frames.
From the 2nd bullet point of ER 9.2,
temperature is applicable to spectacle
frames, and is covered by 4.6. Magnetic
fields, external electrical influences,
electrostatic discharge, pressure, variations
in pressure and acceleration are not
applicable to spectacle frames.
The 3rd and 4th bullet points of ER 9.2 are
not applicable.
9.3 4.9 —
13.3 a) 10.4 The statement in 10.4 is mandatory for the
countries of the Community.
It covers the authorized representative only
(where applicable).
13.3 b) 9, 10.1, 10.5, 10.6 The ER is covered only in respect of the
aspects detailed in the standard.
13.3 i) 10.1 The ER is covered only in respect of the
aspects detailed in the standard.
13.3 j) 10.1, 10.5, 10.6 The ER is covered only in respect of the
aspects detailed in the standard.
13.3 k) 10.1, 10.5, 10.6 The ER is covered only in respect of the
aspects detailed in the standard.
WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European
Standard 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 12870
Fourth edition
2016-11-01
Ophthalmic optics — Spectacle frames
— Requirements and test methods
Optique ophtalmique — Montures de lunettes — Exigences et
méthodes d’essai
Reference number
ISO 12870:2016(E)
©
ISO 2016
ISO 12870:2016(E)
© ISO 2016, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2016 – All rights reserved
ISO 12870:2016(E)
Contents Page
Foreword .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 2
4.1 General . 2
4.2 Physiological compatibility . 3
4.2.1 Construction . 3
4.2.2 General physiological compatibility . 3
4.2.3 Nickel release . 3
4.2.4 Clinical evaluation.
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.