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
- Status
- Withdrawn
- Publication Date
- 01-May-2018
- Withdrawal Date
- 22-Sep-2025
- Technical Committee
- CEN/TC 170 - Ophthalmic optics
- Drafting Committee
- CEN/TC 170 - Ophthalmic optics
- Current Stage
- 9960 - Withdrawal effective - Withdrawal
- Start Date
- 27-Aug-2025
- Completion Date
- 23-Sep-2025
Relations
- Effective Date
- 09-May-2018
- Effective Date
- 19-Jan-2023
Frequently Asked Questions
EN ISO 12870:2018 is a standard published by the European Committee for Standardization (CEN). Its full title is "Ophthalmic optics - Spectacle frames - Requirements and test methods (ISO 12870:2016)". This standard covers: 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.
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.
EN ISO 12870:2018 is classified under the following ICS (International Classification for Standards) categories: 11.040.70 - Ophthalmic equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
EN ISO 12870:2018 has the following relationships with other standards: It is inter standard links to EN ISO 12870:2014, EN ISO 12870:2025. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 12870:2018 is associated with the following European legislation: EU Directives/Regulations: 2007/47/EC, 93/42/EEC; Standardization Mandates: M/023. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
You can purchase EN ISO 12870:2018 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of CEN standards.
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. 4
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
4.8.1 Bridge deformation . 5
4.8.2 Lens retention characteristics . 5
4.8.3 Endurance . 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 .10
8.2.1 Apparatus .10
8.2.2 Procedure .10
8.3 Test for resistance to perspiration .10
8.3.1 Apparatus and reagents .10
8.3.2 Procedure .11
8.4 Bridge deformation and lens retention test . .11
8.4.1 Apparatus .11
8.4.2 Procedure .12
8.5 Endurance test .13
8.5.1 Apparatus .13
8.5.2 Procedure .14
8.6 Test for resistance to ignition .15
8.6.1 Apparatus .15
8.6.2 Procedure .15
8.7 Test for resistance to optical radiation .15
8.7.1 Apparatus .15
ISO 12870:2016(E)
8.7.2 Procedure .16
9 Marking .16
10 Additional information to be supplied by the manufacturer or other person placing
the product on the market .17
11 Reference to this International Standard .18
Annex A (informative) Recommendations for the design of spectacle frames .19
Annex B (informative) Examples of layout of test equipment .22
Annex C (informative) European requirements and legislation on nickel release .25
Bibliography .26
iv © ISO 2016 – All rights reserved
ISO 12870:2016(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 172, Optics and photonics, Subcommittee SC 7,
Ophthalmic optics and instruments.
This fourth edition cancels and replaces the third edition (ISO 12870:2012), which has been technically
revised with the following change:
— 8.8 and Annex C are now covered in more specific standards (ISO/TS 24348:2014 and EN 16128:2015,
respectively) and are now included as appropriate reference to this International Standard (see
4.2.3 and Annex C).
INTERNATIONAL STANDARD ISO 12870:2016(E)
Ophthalmic optics — Spectacle frames — Requirements
and test methods
1 Scope
This International Standard 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.
This International Standard is not applicable to complete custom-made spectacle frames or to products
designed specifically to provide personal eye protection.
2 Normative references
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. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO 105-A02, Textiles — Tests for colour fastness — Part A02: Grey scale for assessing change in colour
ISO 105-B02, Textiles — Tests for colour fastness — Part B02: Colour fastness to artificial light: Xenon arc
fading lamp test
ISO 3696, Water for analytical laboratory use — Specification and test methods
ISO 7998, Ophthalmic optics — Spectacle frames — Lists of equivalent terms and vocabulary
ISO 8596, Ophthalmic optics — Visual acuity testing — Standard optotype and its presentation
ISO 8624:2011, Ophthalmic optics — Spectacle frames — Measuring system and terminology
ISO 11380, Optics and optical instruments — Ophthalmic optics — Formers
ISO 11381, Optics and optical instruments — Ophthalmic optics — Screw threads
ISO/TS 24348:2014, Ophthalmic optics — Spectacle frames — Method for the simulation of wear and
detection of nickel release from metal and combination spectacle frames
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 7998 and ISO 8624 and the
following apply.
3.1
spectacle frame model
spectacle frame produced to a common design, using the same materials (but not necessarily the same
pigmentation) and surface treatment
ISO 12870:2016(E)
3.2
natural organic material
material that has not been synthesized from other raw organic materials and, when processed, remains
essentially in its original state
Note 1 to entry: Processing in this case is defined as cutting, shaping, laminating, bonding, bending, polishing
and heating.
EXAMPLES Natural horn, bamboo and wood.
3.3
custom-made spectacle frame
spectacle frame made to special order for a named patient
EXAMPLE Spectacle frames specially manufactured for wearers with unusual facial characteristics.
4 Requirements
4.1 General
The requirements applicable to different types of spectacle frames are given in Table 1. All spectacle
frame types covered by this International Standard shall comply with the requirements identified
as “general” (g). Requirements marked “O” are optional, but can be required by legislation in some
countries.
Table 1 — Requirements applicable to different types of spectacle frames
a
Subclause
Frame type
4.2.1 4.2.2 4.2.3 4.2.4 4.3 4.4 4.5 4.6 4.7 4.8 4.9 4.10
Rimless and semi-rimless
g g O O O O g g g g g O
mounts
b
All other frame types g g O O g g g g g g g O
Key
Frame type shall meet the requirements of this subclause in order to comply with this International
g
Standard.
O Compliance with this subclause is optional.
4.2.1 Construction
4.2.2 General physiological compatibility
4.2.3 Nickel release
4.2.4 Clinical evaluation
4.3 Measurement system
4.4 Dimensional tolerances on nominal size
4.5 Tolerance on screw threads
4.6 Dimensional stability at elevated temperature
4.7 Resistance to perspiration
4.8 Mechanical stability
4.9 Resistance to ignition
4.10 Resistance to optical radiation
a
Under European legislation, 4.2.1, 4.2.2, 4.2.3, 4.2.4, 4.5, 4.6, 4.7, 4.8 and 4.9 cover some essential requirements.
b
“All other frame types” include plastics and metal spectacle frames, including folding spectacle frames, that have a rim
that completely surrounds the lens periphery.
2 © ISO 2016 – All rights reserved
ISO 12870:2016(E)
4.2 Physiological compatibility
4.2.1 Construction
When tested under the inspection conditions given in 7.2, areas of the spectacle frame that can, either by
design or accident, come into contact with the wearer should be smooth, without sharp protuberances,
and all edges should be rounded.
4.2.2 General physiological compatibility
Spectacle frames shall be designed and manufactured in such a way that, when used under the conditions
and for the purposes intended, they will not compromise the health (and safety) of the wearer. The
risks posed by substances leaking (migrating) from the device that might come into prolonged contact
with the skin shall be reduced by the manufacturer to a practicable minimum and within the limits of
any appropriate regulatory requirement. Special attention shall be given to substances that are known
to be allergenic, carcinogenic, mutagenic or toxic to reproduction.
NOTE 1 The following list, which is given for information, provides examples of documents that can be
examined when checking the innocuousness of materials:
— specification of the materials used;
— safety data sheets relating to the materials;
— information relating to the suitability of the materials for use with food, in medical devices, or other relevant
applications;
— information relating to investigations into the allergenic, carcinogenic, toxicological or mutagenic properties
of the materials, or their toxicity with regard to reproduction;
— information relating to ecotoxicological and other environmental investigations on the materials.
NOTE 2 Reactions can be generated by excessive pressure, for example, due to a poor fit on the face, chemical
irritation or allergy. Rare or idiosyncratic reactions can occur to any material and indicate the need for the
individual to avoid particular types of frames.
NOTE 3 In some countries, specific material properties are mandatory.
4.2.3 Nickel release
Those parts of metal spectacle frames and those metal parts of combination spectacle frames that come
into direct and prolonged contact with the skin of the wearer shall not have a nickel release greater
than 0,5 μg/cm /week when tested in accordance with ISO/TS 24348 or, equivalently, EN 16128.
The parts to be tested shall include the following:
— the front (rims, bridge and, if applicable, brace bar and any nasal bearing surfaces including metal
nose pads), excluding pad arms and lugs;
— the sides including metal collets, but excluding the joints and areas intended to be protected by
plastic end covers (tips);
— metal decorative trims, if fitted on the inside of plastic sides and plastic end covers.
See ISO/TS 24348 or, equivalently, EN 16128 for further details.
NOTE 1 Annex C provides brief information about European requirements and legislation.
NOTE 2 If only indicative information on the extent of nickel release is required, such information can be
obtained by performing one of the tests specified in CEN/CR 12471. See NOTE 2 of Annex C.
ISO 12870:2016(E)
4.2.4 Clinical evaluation
If a spectacle frame is manufactured using materials (e.g. plastics, alloys, coatings or pigments) not
previously used in spectacle frame manufacture, the clinical evaluation shall be made according to the
appropriate International Standard(s), either using the spectacle frame itself or using studies where the
identical material is used in other medical devices.
4.3 Measurement system
The stated nominal dimensions of the spectacle frame shall be in accordance with the measuring
system specified in ISO 8624.
4.4 Dimensional tolerances on nominal size
When measured with a linear measuring device that is accurate to at least 0,1 mm, the following
tolerances shall apply to the marked dimensions of the unglazed spectacle frame using the boxed lens
measurement method described in ISO 8624:
a) horizontal boxed lens size: ±0,5 mm;
b) distance between lenses: ±0,5 mm;
c) overall length of side: ±2,0 mm.
To improve the accuracy of measurement of overall length of side, it is recommended that the drop be
physically straightened. Sinuosity in the intended vertical plane, or pronounced curvature in the
intended horizontal plane in the part of the side before the earbend, should be ignored. The overall
length of side should be taken as the length of the straight line between the dowel screw and the end of
the side. Gentle bowing of the side to go round the width of the head should be straightened. For sides
without a hinged joint, the side should be held open at ()90 ° to the front or to that part of the side that
−5
is attached to the front, and the length is measured from the end of the side to the front, minus 10 mm.
See ISO 8624:2011, Figures 2 and 3 for an illustration of overall length of side.
To simplify the edging of lenses for any single frame model, tighter tolerances in the lens aperture size
from one frame to another of the same nominal size may be a matter of agreement between supplier
and purchaser.
4.5 Tolerance on screw threads
The tolerances on the screw threads used in the spectacle frame shall conform to ISO 11381.
4.6 Dimensional stability at elevated temperature
When the spectacle frame with test lenses fitted is tested in accordance with 8.2, the distance between
the tips of the sides shall not alter by more than +6 mm or −12 mm. For small spectacle frames where
the tip of the side is less than 100 mm from the back plane of the front, these tolerances are reduced to
+5 mm or −10 mm.
4.7 Resistance to perspiration
When the spectacle frame is tested in accordance with 8.3, there shall be
a) no spotting or colour change (except for loss of gloss on surface) anywhere on the frame, excluding
joints and screws, after testing for 8 h, and
b) no corrosion, surface degradation or separation of any coating layer on the parts liable to come into
prolonged contact with the skin during wear, i.e. the insides of the sides, bottom and lower parts of
the rim and the inside of the bridge, after testing for a total of 24 h.
4 © ISO 2016 – All rights reserved
ISO 12870:2016(E)
Such defects shall be visible under the inspection conditions described in 7.2.
If the spectacle frame is made from natural materials and the manufacturer recommends a cream or
wax for its maintenance, then, before testing, the frame(s) shall be prepared with this cream or wax in
accordance with the manufacturer’s instructions. At the end of the test, if the frame fails to meet this
requirement when checked for colour change or surface degradation, use the cream or wax and wait
for one day before checking again for colour change or surface degradation. If the frame has recovered
its original appearance, the spectacle frame is considered to have passed the test; if the frame remains
discoloured, the frame is considered to have failed the test.
4.8 Mechanical stability
4.8.1 Bridge deformation
When tested in accordance with 8.4, the spectacle frame with the test lenses fitted shall not
a) fracture or crack at any point, or
b) be permanently deformed from its original configuration by more than 2 % of the distance, c,
between the boxed centres of the spectacle frame, i.e. the residual deformation, x, shall not exceed
0,02c (see Figure 1).
Key
1 annular clamp
2 pressure peg
3 original position
4 residual deformation, x
Figure 1 — Permanent deformation of bridge
4.8.2 Lens retention characteristics
The spectacle frame shall be considered to demonstrate acceptable lens retention characteristics if,
when tested in accordance with 8.4, neither test lens is dislodged wholly or partially from its original
location in the groove or mount.
4.8.3 Endurance
When tested in accordance with 8.5, the spectacle frame with the test lenses fitted shall not
a) fracture at any point,
b) be permanently deformed from its original position by more than 5 mm after 500 cycles,
ISO 12870:2016(E)
c) require more than light finger pressure to open and close the sides (except for frames fitted with
sprung joints), or
d) have a side that closes under its own weight at any point in the opening/closing cycle (for frames
not fitted with sprung joints), or for sides fitted with sprung joints, the side shall still support its
weight in the open position (i.e. opened to the fullest natural extent without activating the spring
mechanism).
4.9 Resistance to ignition
When the spectacle frame is tested in accordance with 8.6, there shall be no continued combustion
after withdrawal of the test rod.
4.10 Resistance to optical radiation
When tested in accordance with 8.7, there shall be no
a) colour change greater than grade 3 on the grey scale in ISO 105-A02, or
b) loss of lustre on bright surfaces,
when compared with an untested sample under the inspection conditions described in 7.2.
5 Selection of test samples
5.1 General
The minimum level of conformity testing requires that two test specimens of each spectacle frame
model shall be selected at random. These specimens shall be selected by the manufacturer or its
representative, and shall be identified as test sample 1 and test sample 2. They shall be conditioned as
described in Clause 6 before testing as described in Clauses 7 and 8.
In some regions, local legislation requires a spectacle frame model to comply with regulatory
requirements throughout the duration of its supply to the market. When compliance with this
International Standard is claimed, the manufacturer or its representative has the responsibility, by any
chosen means, for example use of ISO 13485, ISO 14971 and/or this International Standard, to ensure
that the compliance of the spectacle frame model continues throughout its duration of supply, and not
only at its first launch on the market.
5.2 Testing for nickel release
For metal and combination spectacle frames, two additional test samples shall be selected at random
and shall be conditioned and tested as specified in ISO/TS 24348 or, equivalently, EN 16128.
5.3 Change in spectacle frame model
If a range of spectacle frame models is made from the same material(s), following the same
manufacturing procedures, including surface treatments, it is acceptable to perform, from Table 2, test
sequences 4 (see 8.3), 8 (see 8.6) and, if required, 9 (see 8.7) and/or 10 on only one of the spectacle
frame models.
6 Preparation and conditioning of test samples
6.1 Test lenses
Prior to testing for the requirements described in 4.6 to 4.10, test samples 1 and 2 shall be fitted with a
pair of suitable test lenses.
6 © ISO 2016 – All rights reserved
ISO 12870:2016(E)
The test lenses shall preferably be supplied or specified by the manufacturer. If these are not supplied
or specified, then the following types shall be used depending upon the type of spectacle frame:
a) for rimless frames, organic lenses of polycarbonate with a vertex power of (0,00 ± 0,25) D, a centre
thickness of (2,00 ± 0,2) mm and a radius of curvature of the concave surface of (90 ± 10) mm;
1)
b) for semi-rimless frames, organic lenses of allyl diglycol carbonate or polycarbonate with a vertex
power of (0,00 ± 0,25) D, a centre thickness of (2,00 ± 0,2) mm and a radius of curvature of the
concave surface of (90 ± 10) mm;
c) for all other frame types, including folding and all rimmed spectacles, either organic lenses as in b),
or silicate glass with a vertex power of (0,00 ± 0,25) D, a centre thickness of (2,25 ± 0,25) mm and a
radius of curvature of the concave surface of (100 ± 20) mm.
For all test samples, these test lenses shall be edged either in accordance with the manufacturer’s
electronic instructions or with a digitally controlled edging machine that uses the tracing made of the
individual test sample or, where appropriate, using a mechanical former in accordance with ISO 11380.
+3
The bevel angle of the edged lens shall be ()120 ° for spectacle frames featuring a rim with a groove.
−2
6.2 Sample conditioning and test conditions
Immediately before starting the series of tests, the test samples shall be conditioned for at least 4 h at
an ambient temperature of (23 ± 5) °C, in the condition as received from the manufacturer or supplier,
without prior realignment, adjustment or lubrication.
Carry out the testing in an atmosphere maintained within the same temperature range.
7 Testing, inspection and compliance
7.1 Testing
The testing shall be carried out with the conditioned test samples (see 6.2) in the sequence specified in
Table 2 at an ambient temperature of (23 ± 5) °C.
Table 2 — Sequence of testing
Nickel
Requirement Test method
Identification of test Sequence Sample 1 Sample 2 release
subclause subclause
samples
Construction 4.2.1 4.2.1 1 *
Dimensional tolerance 4.3, 4.4 4.4 2 *
Dimensional stability 4.6 8.2 3 *
Resistance to perspiration 4.7 8.3 4 *
Bridge deformation 4.8.1 8.4 5 *
Lens retention 4.8.2 8.4 6 *
Endura
...
ISO 12870:2016은 모든 처방 렌즈와 사용하기 위해 설계된 비테이클 프레임에 대한 기본 요구 사항을 명시하고 있다. 이 국제 표준은 제조업체나 공급업체로부터 소매업자에게 판매되는 시점의 프레임에 적용된다. ISO 12870:2016은 프레임리스 삽입형, 반프레임형 및 접이식 비테이클 프레임을 포함한 모든 비테이클 프레임 유형에 적용된다. 또한 천연 유기물 소재로 만든 비테이클 프레임에도 적용된다. 참고: 비테이클 프레임의 디자인에 대한 권장 내용은 부록 A를 참조한다. ISO 12870:2016은 완전히 주문형으로 제작된 비테이클 프레임이나 개인 안전용으로 디자인된 제품에는 적용되지 않는다.
The article discusses the requirements and test methods for unglazed spectacle frames, as specified by the ISO 12870:2016 standard. This applies to all types of spectacle frames, including rimless, semi-rimless, and folding frames. The standard also covers frames made from natural organic materials. However, it does not apply to custom-made frames or those designed for personal eye protection. Annex A provides recommendations for the design of spectacle frames.
ISO 12870:2016は、すべての処方箋レンズに使用される非入れ子の眼鏡フレームに関する基本的な要件とテスト方法を規定しています。この国際規格は、製造業者やサプライヤーから小売業者に販売されるフレームの販売時に適用されます。 ISO 12870:2016は、リムレスマウント、セミリムレスマウント、折り畳み式の眼鏡フレームを含むすべての眼鏡フレームの種類に適用されます。また、天然有機材料から作られた眼鏡フレームにも適用されます。 注:眼鏡フレームの設計に関する推奨事項については、付属書Aを参照してください。 ISO 12870:2016は、完全にカスタムメイドの眼鏡フレームや、個人の目の保護を目的とした製品には適用されません。










Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.
Loading comments...