SIST EN ISO 12870:2025
(Main)Ophthalmic optics - Spectacle frames - Requirements and test methods (ISO 12870:2024)
Ophthalmic optics - Spectacle frames - Requirements and test methods (ISO 12870:2024)
This document specifies fundamental requirements and their test methods for unglazed spectacle frames designed for use with prescription lenses. It is applicable to spectacle frames at the point of sale by the manufacturer or supplier to the retailer.
This document is applicable to:
— all mass-produced spectacle frame types, including rimless mounts, semi-rimless mounts and folding spectacle frames;
— spectacle frames made with additive manufacturing, for example, 3D printing;
— spectacle frames made from natural organic materials;
— the frame or mount of clip-ons designed specifically for attachment to particular models of spectacle frame, but not to their lenses or filters to which ISO 16034 or ISO 12312-1 apply;
— prescription inserts designed for attachment to particular models of, for example, eye protector, sunglass or diving mask.
Parts of this document are applicable to custom-made frames – see 3.1.3 and Table 1.
NOTE See Annex A for recommendations on the design of spectacle frames and terms to be used when describing metal frames.
This document is not applicable to spectacle frames used in eye protection, where ISO 16321-1 applies, or to sunglasses with afocal filters, where ISO 12312-1 applies.
Augenoptik - Brillenfassungen - Anforderungen und Prüfverfahren (ISO 12870:2024)
Dieses Dokument legt grundlegende Anforderungen und deren Prüfverfahren für unverglaste Brillenfassungen fest, die zur Verwendung mit Korrektionsgläsern bestimmt sind. Es ist zum Zeitpunkt des Verkaufs der Brillenfassung durch den Hersteller oder Lieferant an den Wiederverkäufer gültig.
Dieses Dokument ist anwendbar für:
alle serienmäßig hergestellten Brillenfassungsarten, einschließlich randloser, halb-randloser und faltbarer Brillenfassungen;
Brillenfassungen, die durch additive Fertigung, z. B. 3-D-Druck, hergestellt werden;
Brillenfassungen aus natürlichen organischen Materialien;
die Fassung oder die Halterung von Aufsteckscheiben, die speziell für die Befestigung an bestimmten Modellen von Brillenfassungen ausgelegt sind, nicht jedoch an deren Brillengläser oder Filter, für die ISO 16034 oder ISO 12312 1 gilt;
Korrektionseinsätze, die für die Befestigung an bestimmten Modellen von z. B. Augenschutz, Sonnenbrillen oder Tauchmasken ausgelegt sind.
Teile dieses Dokuments sind anwendbar für als Sonderanfertigung angefertigte Brillenfassungen – siehe 3.1.3 und Tabelle 1.
ANMERKUNG Siehe Anhang A für Empfehlungen zur Konstruktion von Brillenfassungen und zur Beschreibung von Metallfassungen zu verwendende Benennungen.
Dieses Dokument ist nicht anwendbar für Brillenfassungen für den Augenschutz, für die ISO 16321 1 gilt, oder für Sonnenbrillen mit afokalen Filtern, für die ISO 12312 1 gilt.
Optique ophtalmique - Montures de lunettes - Exigences et méthodes d'essai (ISO 12870:2024)
Le présent document spécifie les exigences fondamentales et leurs méthodes d’essai relatives aux montures de lunettes dépourvues de verre conçues pour être équipées de verres correcteurs. Il est applicable aux montures de lunettes au point de vente par le fabricant ou le fournisseur jusqu’au détaillant.
Le présent document est applicable:
— à tous les types de montures de lunettes produites en masse, y compris les montures non cerclées, les montures semi-cerclées et les montures pliables;
— aux montures de lunettes produites par fabrication additive, par exemple, impression 3D;
— aux montures de lunettes en matériaux organiques naturels;
— aux montures ou contre-verres («clip-ons») spécifiquement conçus pour être fixés à des modèles particuliers de montures de lunettes, mais pas à leurs verres ou filtres pour lesquels l’ISO 16034 ou l’ISO 12312-1 s’appliquent;
— aux inserts ophtalmiques conçus pour être fixés à des modèles particuliers de protecteurs des yeux, lunettes de soleil ou masques de plongée, par exemple.
Les parties du présent document sont applicables aux montures fabriquées sur mesure – voir 3.1.3 et Tableau 1.
NOTE Voir l’Annexe A pour ce qui concerne les recommandations relatives à la conception des montures de lunettes et les termes à utiliser lors de la description des montures de lunettes en métal.
Le présent document n’est applicable ni aux montures de lunettes utilisées pour la protection des yeux, pour lesquelles l’ISO 16321-1 s’applique, ni aux lunettes de soleil équipées de filtres afocaux, pour lesquelles l’ISO 12312-1 s’applique.
Očesna optika - Okviri očal - Zahteve in preskusne metode (ISO 12870:2024)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-oktober-2025
Nadomešča:
SIST EN ISO 12870:2018
Očesna optika - Okviri očal - Zahteve in preskusne metode (ISO 12870:2024)
Ophthalmic optics - Spectacle frames - Requirements and test methods (ISO
12870:2024)
Augenoptik - Brillenfassungen - Anforderungen und Prüfverfahren (ISO 12870:2024)
Optique ophtalmique - Montures de lunettes - Exigences et méthodes d'essai (ISO
12870:2024)
Ta slovenski standard je istoveten z: EN ISO 12870:2025
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
August 2025
EUROPÄISCHE NORM
ICS 11.040.70 Supersedes EN ISO 12870:2018
English Version
Ophthalmic optics - Spectacle frames - Requirements and
test methods (ISO 12870:2024)
Optique ophtalmique - Montures de lunettes - Augenoptik - Brillenfassungen - Anforderungen und
Exigences et méthodes d'essai (ISO 12870:2024) Prüfverfahren (ISO 12870:2024)
This European Standard was approved by CEN on 17 November 2024.
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, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye 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
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 12870:2025 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered. 4
European foreword
This document (EN ISO 12870:2025) 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 February 2026, and conflicting national standards
shall be withdrawn at the latest by February 2026.
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 12870:2018.
This document has been prepared under a standardization request addressed to CEN by the European
Commission. The Standing Committee of the EFTA States subsequently approves these requests for its
Member States.
For the relationship with EU Legislation, see informative Annex ZA, which is an integral part of this
document.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 12870:2024 has been approved by CEN as EN ISO 12870:2025 without any modification.
Annex ZA
(informative)
Relationship between this European standard and
the General Safety and Performance Requirements of
Regulation (EU) 2017/745 aimed to be covered
This European standard has been prepared under M/575 to provide one voluntary means of
conforming to the General Safety and Performance Requirements of Regulation (EU) 2017/745 of 5
April 2017 concerning medical devices [OJ L 117] and to system or process requirements including
those relating to quality management systems, risk management, post-market surveillance systems,
clinical investigations, clinical evaluation or post-market clinical follow-up.
Once this standard is cited in the Official Journal of the European Union under that Regulation,
compliance with the normative clauses of this standard given in Table ZA.1 and application of the
edition of the normatively referenced standards as given in Table ZA.2 confers, within the limits of the
scope of this standard, a presumption of conformity with the corresponding General Safety and
Performance Requirements of that Regulation, and associated EFTA Regulations.
Where a definition in this standard differs from a definition of the same term set out in Regulation (EU)
2017/745, the differences shall be indicated in this Annex Z. For the purpose of using this standard in
support of the requirements set out in Regulation (EU) 2017/745, the definitions set out in this
Regulation prevail.
Where the European standard is an adoption of an International Standard, the scope of this standard
can differ from the scope of the European Regulation that it supports. As the scope of the applicable
regulatory requirements differ from nation to nation and region to region, the standard can only
support European regulatory requirements to the extent of the scope of the European regulation for
medical devices (EU) 2017/745).
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 Regulation (EU) 2017/745. This means that risks have to be
‘reduced as far as possible’, ‘reduced to the lowest possible level’, ‘reduced as far as possible and appropriate’,
‘removed or reduced as far as possible’, ‘eliminated or reduced as far as possible’, ’removed or minimized as far as
possible’, or ‘minimized’, according to the wording of the corresponding General Safety and Performance
Requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with General Safety
and Performance Requirements 1, 2, 3, 4, 5, 8, 9, 10, 11, 14, 16, 17, 18, 19, 20, 21 and 22 of the Regulation.
NOTE 3 When a General Safety and Performance 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 Regulation (EU)
2017/745 [OJ L 117]
General Safety and
Clause(s)/subclause(s)
Performance Requirements Remarks/notes
of this EN
of Regulation (EU) 2017/745
1 4 Clause 4 of the standard only
meets the requirements of
Annex I, GSPR 4 of the
Regulation in respect of
detailing the requirements for
spectacle frames.
3 a) 4.3 4.3 of the standard only
partially meets the
requirements of Annex I, GSPR
3 (a) of the Regulation in
respect of risk management
since it gives only general
guidance.
4 (a) 4.2 4.2 of the standard only
partially meets the
requirements of Annex I, GSPR
4 (a) of the Regulation in
respect of construction since it
gives only guidance.
5 (a) 4.2, 4.12 4.2 and 4.12 of the standard
only partially meet the
requirements of Annex I, GSPR
5 (a) of the Regulation in
respect of reducing risk (4.2)
and mechanical stability (4.12).
6 4.10, 4.11, 4.12 4.10, 4.11 and 4.12 of the
standard only partially meet
the requirements of Annex I,
GSPR 6 of the Regulation in
respect of possible changes in
shape caused by raised
temperature (4.10), surface
quality (4.11) and mechanical
strength (4.12).
7 4.10 4.10 of the standard only meets
the requirements of Annex I,
GSPR 7 of the Regulation in
respect of temperature when in
use but not in packaging or
transport. The test
temperature is, however,
greater than any likely to be
met during transport.
General Safety and
Clause(s)/subclause(s)
Performance Requirements Remarks/notes
of this EN
of Regulation (EU) 2017/745
10.1 (a) 4.4, 4.13 4.4 and 4.13 of the standard
only meet the requirements of
Annex I, GSPR 10.1 (a) of the
Regulation in respect of
flammability (4.13) and only
partially met with respect to
toxicity by the guidance on
materials in 4.4.
10.1 (b) 4.4, 4.5, 4.11 4.5 of the standard only meets
the requirements of Annex I,
GSPR 10.1 (b) of the Regulation
in respect of nickel allergy
(4.5);
4.4 and 4.11 of the standard
only partially meet the
requirements of Annex I, GSPR
10.1 (b) of the Regulation in
respect of manufacture since
while 4.4 gives guidance on the
materials that can be used, it
does not specifically address
the aspects of chemicals from
the frame being absorbed,
distributed, metabolised and
excreted. 4.11 covers damage
to the surface by perspiration,
which might be a two-way
process, allowing damaged
constituents of the frame to
enter the skin.
10.1 (d) 4.5 4.5 of the standard only meets
the requirements of Annex I,
GSPR 10.1 (d) of the Regulation
in respect of nickel release –
the welding of metals to
construct a spectacle frame can
result in changes to the original
material properties of the
metals.
10.1 (f) 4.12 4.12 of the standard only meets
the requirements of Annex I,
GSPR 10.1 (f) of the Regulation
in respect of all listed
mechanical properties except
ductility which is not relevant
to spectacle frames.
General Safety and
Clause(s)/subclause(s)
Performance Requirements Remarks/notes
of this EN
of Regulation (EU) 2017/745
10.1 (g) 4.2, 4.11 4.2 and 4.11 of the standard
only meet the requirements of
Annex I, GSPR 10.1 (g) of the
Regulation in respect of surface
quality when new by 4.2 and
after wear by 4.11
10.4.1 4.5 4.5 of the standard only
partially meets the
requirements of Annex I, GSPR
10.4.1 of the Regulation in
respect of nickel release
10.4.3 4.4 4.4 of the standard only
partially meets the
requirements of Annex I, GSPR
10.4.3 of the Regulation in
respect of phthalates which are
not specifically mentioned;
manufacturers are aware of
these substances.
14.1 4.12.2 4.12.2 of the standard only
meets the requirements of
Annex I, GSPR 14.1 of the
Regulation in respect of
retaining spectacle lenses.
14.2 (a) 4.8 4.8 of the standard only
partially meets the
requirements of Annex I, GSPR
14.2 (a) of the Regulation in
respect of dimensional
tolerances.
14.2 (b) 4.10 4.10 of the standard only
partially meets the
requirements of Annex I,
GSPR 14.2 (b) of the Regulation
in respect of temperature. All
the other external influences
are not applicable.
14.3 4.13 4.13 of the standard only
partially meets the
requirements of Annex I,
GSPR 14.3 of the Regulation in
respect of the risk of catching
fire.
14.5 4.12.2 4.12.2 of the standard only
meets the requirements of
General Safety and
Clause(s)/subclause(s)
Performance Requirements Remarks/notes
of this EN
of Regulation (EU) 2017/745
Annex I, GSPR 14.5 of the
Regulation in respect of
compatibility with spectacle
lenses required by the lens
retention test in 4.12.2.
20.1 4.12 4.12 of the standard only meets
the requirements of Annex I,
GSPR 20.1 of the Regulation in
respect of mechanical
performance.
22.1 4.2, 4.4 ,4.10, 4.11 4.12 4.2, 4.4, 410, 4.11 and 4.12 of
the standard together only
meet the requirements of
Annex I, GSPR 22.1 of the
Regulation in respect of
performance requirements
from the wearer's point of
view. Spectacle frames are
intentionally designed for use
by lay persons and as a Class I
product have no information
for users.
23.1 (a) 9 9 of the standard only meets
the requirements of Annex I,
GSPR 23.1 (a) of the Regulation
in respect of the labelling to be
put on a spectacle frame.
23.1 (b) 9 9 of the standard only meets
the requirements of Annex I,
GSPR 23.1 (b) of the Regulation
in respect of the labelling to be
put on a spectacle frame.
23.2 (c) 10.4 10.4 of the standard only
partially meets the
requirements of Annex I,
GSPR 23.2 (c) of the Regulation
in respect of the
manufacturer's or agent's
name and address.
Spectacle frames do not have
labels but are usually mounted
on an accompanying card. If
not, information can be
provided on the packaging or
in catalogues or electronic
database.
Table ZA.2 — Normative references from clause 2 of this document and their
corresponding European publications
Column 1 Column 2 Column 3 Column 4
Reference in International
Title Corresponding European
Clause 2 Standard edition
St
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