SIST EN ISO 12870:2018

Ophthalmic optics - Spectacle frames - Requirements and test methods (ISO 12870:2016)

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, semirimless
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.

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: Published
• Public Enquiry End Date: 14-Sep-2015
• Publication Date: 11-Jun-2018
• ICS: 11.040.70 - Ophthalmic equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 24-May-2018
• Due Date: 29-Jul-2018
• Completion Date: 12-Jun-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 12870:2018 - Ophthalmic optics - Spectacle frames - Requirements and test methods (ISO 12870:2016)

Relations

• Revises: oSIST prEN ISO 12870:2022 - Ophthalmic optics - Spectacle frames - Requirements and test methods (ISO/DIS 12870:2022)
• Effective Date: 18-Jan-2023
• Revises: oSIST prEN ISO 12870:2022 - Ophthalmic optics - Spectacle frames - Requirements and test methods (ISO/DIS 12870:2022)
• Effective Date: 19-Jan-2023
• Replaces: SIST EN ISO 12870:2015 - Ophthalmic optics - Spectacle frames - Requirements and test methods (ISO 12870:2012)
• Effective Date: 01-Jul-2018
• Revised: oSIST prEN ISO 12870:2022 - Ophthalmic optics - Spectacle frames - Requirements and test methods (ISO/DIS 12870:2022)
• Effective Date: 04-Dec-2019

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 12870:2018
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
SIST EN ISO 12870:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 12870:2018

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SIST EN ISO 12870:2018


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.

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SIST EN ISO 12870:2018
EN ISO 12870:2018 (E)
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

2

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SIST EN ISO 12870:2018
EN ISO 12870:2018 (E)
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
EN ISO 12870:2018 by 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 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
3

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SIST EN ISO 12870:2018
EN ISO 12870:2018 (E)
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.
4

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SIST EN ISO 12870:2018
EN ISO 12870:2018 (E)
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.
5

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SIST EN ISO 12870:2018
EN ISO 12870:2018 (E)
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
2
(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
6

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SIST EN ISO 12870:2018
EN ISO 12870:2018 (E)
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.

7

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SIST EN ISO 12870:2018

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SIST EN ISO 12870:2018
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

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SIST EN ISO 12870:2018
ISO 12870:2016(E)

COPYRIGHT PROTECTED DOCUMENT
© 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. [phone]
Fax [phone]
[e-mail]
www.iso.org
ii © ISO 2016 – All rights reserved

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SIST EN ISO 12870:2018
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 2016 – All rights reserved iii

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SIST EN ISO 12870:2018
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

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SIST EN ISO 12870:2018
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).
© ISO 2016 – All rights reserved v

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SIST EN ISO 12870:2018

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SIST EN ISO 12870:2018
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 2016 – All rights reserved 1

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SIST EN ISO 12870:2018
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 ma
...