oSIST prEN ISO 12870:2022
(Main)Ophthalmic optics - Spectacle frames - Requirements and test methods (ISO/DIS 12870:2022)
Ophthalmic optics - Spectacle frames - Requirements and test methods (ISO/DIS 12870:2022)
Augenoptik - Brillenfassungen - Anforderungen und Prüfverfahren (ISO/DIS 12870:2022)
Optique ophtalmique - Montures de lunettes - Exigences et méthodes d'essai (ISO/DIS 12870:2022)
Očesna optika - Okviri očal - Zahteve in preskusne metode (ISO/DIS 12870:2022)
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN ISO 12870:2022
01-april-2022
Očesna optika - Okviri očal - Zahteve in preskusne metode (ISO/DIS 12870:2022)
Ophthalmic optics - Spectacle frames - Requirements and test methods (ISO/DIS
12870:2022)
Augenoptik - Brillenfassungen - Anforderungen und Prüfverfahren (ISO/DIS 12870:2022)
Optique ophtalmique - Montures de lunettes - Exigences et méthodes d'essai (ISO/DIS
12870:2022)
Ta slovenski standard je istoveten z: prEN ISO 12870
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
oSIST prEN ISO 12870:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 12870:2022
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oSIST prEN ISO 12870:2022
DRAFT INTERNATIONAL STANDARD
ISO/DIS 12870
ISO/TC 172/SC 7 Secretariat: DIN
Voting begins on: Voting terminates on:
2022-01-24 2022-04-18
Ophthalmic optics — Spectacle frames — Requirements
and test methods
Optique ophtalmique — Montures de lunettes — Exigences et méthodes d'essai
ICS: 11.040.70
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 12870:2022(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2022
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oSIST prEN ISO 12870:2022
ISO/DIS 12870:2022(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2022
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
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oSIST prEN ISO 12870:2022
ISO/DIS 12870:2022(E)
Contents Page
Foreword .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
3.1 General terms . 2
3.2 Types of frame . . . 3
3.3 Terms describing frame materials and frames made from specific metals . 4
4 Requirements . 5
4.1 General . 5
4.2 Physiological compatibility . 7
4.2.1 Construction. 7
4.2.2 General physiological compatibility. 7
4.2.3 Nickel release . 8
4.2.4 Clinical evaluation. 8
4.3 Measurement system . 8
4.4 Dimensional tolerances on nominal size . 8
4.5 Tolerance on screw threads (optional) . 9
4.6 Dimensional stability at elevated temperature . 9
4.7 Resistance to perspiration . 9
4.8 Mechanical stability . 9
4.8.1 Bridge deformation . 9
4.8.2 Lens retention characteristics . 10
4.8.3 Endurance . 10
4.9 Resistance to ignition . 11
4.10 Resistance to optical radiation (optional) . 11
5 Selection of test samples .11
5.1 General . 11
5.2 Testing for nickel release . 11
5.3 Change in spectacle frame model . 11
6 Preparation and conditioning of test samples .11
6.1 Test lenses . 11
6.2 Sample conditioning and test conditions .12
7 Testing, inspection and compliance .12
7.1 Testing .12
7.2 Inspection and examination .12
7.3 Compliance .12
8 Test methods .13
8.1 General .13
8.2 Test for dimensional stability. 14
8.2.1 Apparatus . 14
8.2.2 Procedure . 14
8.3 Test for resistance to perspiration . 14
8.3.1 Apparatus and reagents . . 14
8.3.2 Procedure .15
8.4 Bridge deformation and lens retention . 15
8.4.1 Apparatus . 15
8.4.2 Procedure . 16
8.5 Endurance test . 17
8.5.1 Apparatus . 17
8.5.2 Procedure . 18
8.6 Test for resistance to ignition . 19
8.6.1 Apparatus . 19
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oSIST prEN ISO 12870:2022
ISO/DIS 12870:2022(E)
8.6.2 Procedure . 19
8.7 Test for resistance to optical radiation . 20
8.7.1 Apparatus . 20
8.7.2 Procedure . 20
9 Marking . .21
10 Additional information to be supplied by the manufacturer or other person placing
the product on the market .22
11 Reference to this document.22
Annex A (informative) Recommendations for the design of spectacle frames .23
Annex B (informative) Examples of layout of test equipment .25
Annex C (informative) European requirements and legislation on nickel release .28
Annex D (normative) Long wavelength pass filter .29
Annex E (informative) Identification marking or labelling of handling requirements
(optional) .33
Annex ZA (informative) Relationship between this European standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered .34
Annex ZB (informative) Relationship between this European standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered .38
Bibliography .42
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oSIST prEN ISO 12870:2022
ISO/DIS 12870:2022(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 voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
URL: www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee
SC 7, Ophthalmic optics and instruments.
This fifth edition cancels and replaces the fourth edition (ISO 12870:2016), which has been technically
revised.
The main changes compared to the previous edition are as follows:
— rimmed clip-ons, prescription inserts, and frames made by additive manufacture are now included
in the scope;
— additional terms and definitions;
— clarification of the tests to be applied for the physiological properties of custom-made frames in
Table 1 (in 4.1);
— some re-arrangement of and additional text in 4.2;
— simplification of the text in 4.2 to make it more general, and addition of a note on magnets;
— minor changes to 4.2.1, 6.1, 8.5.2.3, 8.6, 8.7 (with a new Annex D), 9 and 10.3;
— 4.5 has been made optional, while the original 10.5 and 10.6 are now in a Note to 4.2.1;
— a new 10.5 refers to an informative Annex E on frame handling information.
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oSIST prEN ISO 12870:2022
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oSIST prEN ISO 12870:2022
DRAFT INTERNATIONAL STANDARD ISO/DIS 12870:2022(E)
Ophthalmic optics — Spectacle frames — Requirements
and test methods
1 Scope
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 3.11 and Table 1.
NOTE See Annex A for recommendations on the design of spectacle 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.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. 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 8624:2020, Ophthalmic optics — Spectacle frames — Measuring system and vocabulary
ISO 11380, Optics and optical instruments — Ophthalmic optics — Formers
ISO 11381, Ophthalmic optics — Spectacle frames — 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
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oSIST prEN ISO 12870:2022
ISO/DIS 12870:2022(E)
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.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1 General terms
3.1.1
spectacle frame model
spectacle frame produced to a common design, using the same materials (but not necessarily the same
pigmentation) and surface treatment
3.1.2
mass-produced frame
frame that is based on standardized dimensions/designs and is typically produced in a continuous
production run or homogenous batch
Note 1 to entry: A homogeneous batch will be made to the same specifications using the same machine/
equipment set-up.
Note 2 to entry: A mass-produced frame is not designed for a particular individual, but may have to be adapted to
fit the wearer's facial features during dispensing and will be adapted by fitting it with spectacle lenses.
[SOURCE: Adapted from IMDRF N49: 2018, 4.7 and 4.8]
3.1.3
custom-made frame
frame made to a written request from an authorized healthcare professional for the sole use of a
particular individual to address the specific anatomo-physiological features or pathological condition
of the individual for whom it is intended
Note 1 to entry: spectacle frames that are patient-matched, adaptable or mass-produced shall not be considered
to be custom-made.
Note 2 to entry: A custom-made spectacle frame is intended for a case where an individual’s specific needs
cannot be met, or cannot be met at the appropriate level of performance, by an alternative device available on the
market.
[SOURCE: IMDRF N49: 2018, 4.2, definition abbreviated to fit ISO Rules.]
3.1.4
principal components
rims, bridge, lugs, sides and metal nose pads
Note 1 to entry: For a frame of which the front is made of plastics materials, but the sides and/or lugs of metal, the
sides and/or lugs are regarded as principal components.
3.1.5
non-principal components
all components of the spectacle frame that are not principal components (3.1.4)
Note 1 to entry: Typical non-principal components include joints, sprung joints, screws, closing blocks, solders,
washers, bushings, nuts of screw assemblies, dowel pins, metal cores for plastics sides, plastics nose pads,
1)
plastics hoods, plastics end covers, plastics inner winding and cores of curl sides.
1) See ISO 7998 for a pictorial illustration of many of these terms.
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oSIST prEN ISO 12870:2022
ISO/DIS 12870:2022(E)
3.1.6
trained observer
person trained in testing of frames with a binocular decimal visual acuity of at least 1,0 (6/6 or 20/20)
and wearing the appropriate refractive correction, if necessary, for the observation distance of the test
[SOURCE: ISO 4007: 2018, 3.11.1, modified by replacing "eye and face protectors" with "frames".]
3.1.7
test lens
lens as described in 6.1 to be mounted into the frame for testing the frame's requirements
3.2 Types of frame
3.2.1
plastics frame
frame of which the principal parts (3.1.4) of the front are made of a plastics material
3.2.2
frame made of natural organic materials
frame of which the principal parts (3.1.4) of the frame are made of natural organic materials (3.3.1)
Note 1 to entry: For the purposes of terminology, a frame from natural organic materials has the same
construction as a plastics frame, the material having some properties similar to those of a plastic material.
3.2.3
metal frame
frame of which the principal components (3.1.4) of the frame are made of metal
3.2.4
folding frame
frame hinged at the bridge, and possibly in the sides, so as to fold into a small space
3.2.5
combination frame
frame of which the front and/or sides are made of at least two different categories of material
Note 1 to entry: The non-principal components (3.1.5) are excluded from consideration in this definition.
Note 2 to entry: Categories of material include but are not limited to metal, plastic and natural organic materials.
Note 3 to entry: This includes the original meaning of the term when the combination depended only on the
construction of the front.
3.2.6
mount for rimless and semi-rimless spectacles
mount of which the front is made of metal or of a plastics material or a natural organic material (3.3.1)
having similar properties, or a combination of both, and in which the lenses are not or only partially
surrounded by a protecting rim
3.2.7
mixed frame
frame in which the components liable to come into close and prolonged contact with the skin are made
of at least two different categories of material
Note 1 to entry: All components are included, both principal components (3.1.4) and non-principal components
(3.1.5).
Note 2 to entry: Categories of material include but are not limited to metal, plastic and natural organic materials.
Note 3 to entry: This definition is used only for descriptions for testing purposes, not for frame categorization
when marketing or in catalogues.
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oSIST prEN ISO 12870:2022
ISO/DIS 12870:2022(E)
3.2.8
clip-on
pair of lenses/filters or a one-piece lens or filter designed to clip on over the front of or behind a pair of
spectacles
Note 1 to entry: for the purposes of this document, the term is restricted to designs with a rim that fit on the
front.
[SOURCE: ISO 4007:2018, 3.5.1.14, modified by the addition of the note 1 to entry.]
3.2.9
prescription insert
device for carrying prescription lenses that is intended to be attached on the inside of the protector
between the eyes of the wearer and the protective lens
Note 1 to entry: Prescription inserts can be used with eye and face protectors for occupational use, sunglasses,
diving goggles, augmented reality devices, etc.
[SOURCE: ISO 4007:2018, 3.5.1.15, modified by the addition of the note to entry.]
3.3 Terms describing frame materials and frames made from specific metals
3.3.1
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.
EXAMPLE Natural horn, bamboo and wood.
3.3.2
rolled-gold covering
covering achieved using a method by which a layer of gold alloy is bonded to a sheet or bar of base
metal, the whole then being subjected to reduction by rolling
Note 1 to entry: Adapted from ISO 3160-1:1998, 3.1.
Note 2 to entry: The proportion of gold is designated by its nominal thickness, in micrometres, and by the fineness
of the gold alloy covering the base metal, for example, 40 µm nominal thickness of 500 fineness gold alloy. In
accordance with ISO 3160-1, the range of nominal thicknesses, in micrometres, are 5 µm, 10 µm, 20 µm, 40 µm,
80 µm, 100 µm and 120 µm, with a tolerance of −20 %, and the fineness is defined as the proportion of pure gold
contained in the gold alloy, normally expressed in thousandths (41,67 thousandths = 1 carat).
Note 3 to entry: To clarify that the frame is made from rolled-gold material, the initials L or RG can also be marked
on the frame.
3.3.3
rolled-gold spectacle frame
frame of which each of the metal principal components (3.1.4) is made of a material with a rolled-gold
covering
3.3.4
titanium frame
%
frame of which each of the metal principal components (3.1.4) is made of an alloy containing at least 70
titanium by mass and has a non-nickel containing coating
3.3.5
pure titanium frame
frame of which each of the metal principal components (3.1.4) is made of an alloy containing at least
90 % tit
...
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