SIST EN ISO 12870:2015
(Main)Ophthalmic optics - Spectacle frames - Requirements and test methods (ISO 12870:2012)
Ophthalmic optics - Spectacle frames - Requirements and test methods (ISO 12870:2012)
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.
Augenoptik - Brillenfassungen - Anforderungen und Prüfverfahren (ISO 12870:2012)
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 12870:2012)
Očesna optika - Okviri očal - Zahteve in preskusne metode (ISO 12870:2012)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 12870:2015
01-januar-2015
1DGRPHãþD
SIST EN ISO 12870:2012
2þHVQDRSWLND2NYLULRþDO=DKWHYHLQSUHVNXVQHPHWRGH ,62
Ophthalmic optics - Spectacle frames - Requirements and test methods (ISO
12870:2012)
Augenoptik - Brillenfassungen - Anforderungen und Prüfverfahren (ISO 12870:2012)
Optique ophtalmique - Montures de lunettes - Exigences et méthodes d'essai (ISO
12870:2012)
Ta slovenski standard je istoveten z: EN ISO 12870:2014
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 12870:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN ISO 12870:2015
---------------------- Page: 2 ----------------------
SIST EN ISO 12870:2015
EUROPEAN STANDARD
EN ISO 12870
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2014
ICS 11.040.70 Supersedes EN ISO 12870:2012
English Version
Ophthalmic optics - Spectacle frames - Requirements and test
methods (ISO 12870:2012)
Optique ophtalmique - Montures de lunettes - Exigences et Augenoptik - Brillenfassungen - Anforderungen und
méthodes d'essai (ISO 12870:2012) Prüfverfahren (ISO 12870:2012)
This European Standard was approved by CEN on 3 October 2014.
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, 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: Avenue Marnix 17, B-1000 Brussels
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 12870:2014 E
worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 12870:2015
EN ISO 12870:2014 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical Devices .4
2
---------------------- Page: 4 ----------------------
SIST EN ISO 12870:2015
EN ISO 12870:2014 (E)
Foreword
The text of ISO 12870:2012 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 12870:2014 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 April 2015, and conflicting national standards shall be withdrawn at the
latest by April 2015.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 12870:2012.
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.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 12870:2012 has been approved by CEN as EN ISO 12870:2014 without any modification.
3
---------------------- Page: 5 ----------------------
SIST EN ISO 12870:2015
EN ISO 12870:2014 (E)
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical Devices
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC on Medical Devices.
Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in table ZA 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.
Table ZA.1 — Correspondence between this European Standard
and Directive 93/42/EEC on Medical Devices
Clauses/sub-clauses Essential Requirements (ERs) Qualifying remarks/notes
of this EN of Directive 93/42/EEC
4.2.1, 4.2.2, 4.2.3 7.2 Testing according to 8.8.
The requirement of 4.2.3 (i.e.
2
0,5 μg/cm /week) is the requirement set
forth by Entry 27 of Annex XVII to REACH.
The test in 8.8 makes reference to
EN 16128 and EN 12472. See also
explanations in Annex D.
4.6 to 4.9 7.3 Testing according to 8.2 to 8.6
4.2.2, 4.2.3 7.5 Testing according to 8.8.
Essential Requirement 7.5 is only partly
addressed in ISO 12870. To the extent that
it is covered in ISO 12870, testing
according to 8.8.
The requirement of 4.2.3 (i.e.
2
0,5 μg/cm /week) is the requirement set
forth by Entry 27 of Annex XVII to REACH.
The test in 8.8 makes reference to
EN 16128 and EN 12472. See also
explanations in Annex D.
4.8 9.1 Testing according to 8.4 and 8.5.
4.9 9.3 Testing according to 8.6.
9,10 13.1 —
9,10 13.3 The statement in 10.4 is true
for the countries of the Community
[cf. ER 13.3 a)].
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
4
---------------------- Page: 6 ----------------------
SIST EN ISO 12870:2015
INTERNATIONAL ISO
STANDARD 12870
Third edition
2012-04-01
Ophthalmic optics — Spectacle frames —
Requirements and test methods
Optique ophtalmique — Montures de lunettes — Exigences et
méthodes d’essai
Reference number
ISO 12870:2012(E)
©
ISO 2012
---------------------- Page: 7 ----------------------
SIST EN ISO 12870:2015
ISO 12870:2012(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2012
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO’s
member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2012 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 12870:2015
ISO 12870:2012(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 2
4.1 General . 2
4.2 Physiological compatibility . 3
4.3 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
4.9 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 . 9
8.3 Test for resistance to perspiration .10
8.4 Bridge deformation and lens retention test . 11
8.5 Endurance test .13
8.6 Test for resistance to ignition .14
8.7 Test for resistance to optical radiation .15
8.8 Nickel release .16
9 Marking .18
10 Additional information to be supplied by the manufacturer or other person placing the product
on the market .19
11 Reference to ISO 12870 .20
Annex A (informative) Recommendations for the design of spectacle frames .21
Annex B (informative) Examples of layout of test equipment .23
Annex C (informative) Examples of locations for cutting metal spectacle frames before testing for
nickel release .26
Annex D (informative) European requirements and legislation on nickel release.27
Bibliography .28
© ISO 2012 – All rights reserved iii
---------------------- Page: 9 ----------------------
SIST EN ISO 12870:2015
ISO 12870:2012(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 12870 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 7,
Ophthalmic optics and instruments.
This third edition cancels and replaces the second edition (ISO 12870:2004) which has been technically revised.
iv © ISO 2012 – All rights reserved
---------------------- Page: 10 ----------------------
SIST EN ISO 12870:2015
INTERNATIONAL STANDARD ISO 12870:2012(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 referenced documents are indispensable for the application 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 3160-1, Watch cases and accessories — Gold alloy coverings — Part 1: General requirements
ISO 3696:1987, 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, Ophthalmic optics — Spectacle frames — Method for the simulation of wear and detection of
nickel release from coated 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 2012 – All rights reserved 1
---------------------- Page: 11 ----------------------
SIST EN ISO 12870:2015
ISO 12870:2012(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
EXAMPLES Natural horn, bamboo and wood.
NOTE Processing in this case is defined as cutting, shaping, laminating, bonding, bending, polishing and heating.
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 may 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 give essential requirements.
b
“All other frame types” includes plastics and metal spectacle frames, including folding spectacle frames, that have a rim that
completely surrounds the lens periphery.
2 © ISO 2012 – All rights reserved
---------------------- Page: 12 ----------------------
SIST EN ISO 12870:2015
ISO 12870:2012(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 may, 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 existing 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, e.g. 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
2
0,5 μg/cm /week when tested in accordance with 8.8.
The parts to be tested shall include:
— the rear surface of both rims (for full-rim designs, the top part of the rim need not be tested provided the
lower part is tested and the whole rim is manufactured from the same design and material);
— the rear and lower surface of the bridge (except when a non-metallic insert bridge has been fitted), the rear
and upper surface of any brace bar and any other nasal bearing surfaces, including metal nose pads;
— sides, including metal collets, but excluding the joints and the zone immediately around the joints, and
parts intended to be protected by plastics end covers (tips);
— metal decorative trims, if fitted, on the inside of plastics sides and plastics end covers.
Each of these sets of components shall be tested separately for nickel release, and each set shall pass in
order for the frame to pass. If both sides are tested, the results for each side, not their average, shall be used
to determine whether or not the sides pass.
Heads of screws on folding frames, or holding plastics components onto metal frames, that might come into
contact with the skin shall also be tested as part of the front or side to which they are screwed.
© ISO 2012 – All rights reserved 3
---------------------- Page: 13 ----------------------
SIST EN ISO 12870:2015
ISO 12870:2012(E)
Metal frames that are uncoated and made of homogeneous alloys or metals do not require a wear pre-treatment
(such as that specified in 8.8.2) and shall be tested directly in accordance with 8.8.3 or 8.8.4. Unless the manufacturer
certifies that a component is homogeneous and uncoated, the component shall be assumed to be coated.
If only indicative information on the extent of nickel release is required, such information can be obtained by
[3]
performing one of the tests specified in CEN/CR 12471:2002 .
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
0
open at ()90 ° to the front or to that part of the side that is attached to the front, and the length is measured
−5
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
4 © ISO 2012 – All rights reserved
---------------------- Page: 14 ----------------------
SIST EN ISO 12870:2015
ISO 12870:2012(E)
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.
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) fractu
...
SLOVENSKI STANDARD
kSIST FprEN ISO 12870:2014
01-julij-2014
2þHVQDRSWLND2NYLULRþDO=DKWHYHLQSUHVNXVQHPHWRGH ,62
Ophthalmic optics - Spectacle frames - Requirements and test methods (ISO
12870:2012)
Augenoptik - Brillenfassungen - Anforderungen und Prüfverfahren (ISO 12870:2012)
Optique ophtalmique - Montures de lunettes - Exigences et méthodes d'essai (ISO
12870:2012)
Ta slovenski standard je istoveten z: FprEN ISO 12870
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
kSIST FprEN ISO 12870:2014 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
kSIST FprEN ISO 12870:2014
---------------------- Page: 2 ----------------------
kSIST FprEN ISO 12870:2014
EUROPEAN STANDARD
FINAL DRAFT
FprEN ISO 12870
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2014
ICS 11.040.70 Will supersede EN ISO 12870:2012
English Version
Ophthalmic optics - Spectacle frames - Requirements and test
methods (ISO 12870:2012)
Optique ophtalmique - Montures de lunettes - Exigences et Augenoptik - Brillenfassungen - Anforderungen und
méthodes d'essai (ISO 12870:2012) Prüfverfahren (ISO 12870:2012)
This draft European Standard is submitted to CEN members for unique acceptance procedure. It has been drawn up by the Technical
Committee CEN/TC 170.
If this draft becomes a European Standard, 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.
This draft European Standard was established by CEN 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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
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.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. FprEN ISO 12870:2014 E
worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
kSIST FprEN ISO 12870:2014
FprEN ISO 12870:2014 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical Devices .4
2
---------------------- Page: 4 ----------------------
kSIST FprEN ISO 12870:2014
FprEN ISO 12870:2014 (E)
Foreword
The text of ISO 12870:2012 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 FprEN ISO
12870:2014 by Technical Committee CEN/TC 170 “Ophthalmic optics” the secretariat of which is held by DIN.
This document is currently submitted to the Unique Acceptance Procedure.
This document will supersede EN ISO 12870:2012.
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.
For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document.
Endorsement notice
The text of ISO 12870:2012 has been approved by CEN as FprEN ISO 12870:2014 without any modification.
3
---------------------- Page: 5 ----------------------
kSIST FprEN ISO 12870:2014
FprEN ISO 12870:2014 (E)
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical Devices
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC on Medical Devices.
Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in table ZA 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.
Table ZA.1 — Correspondence between this European Standard
and Directive 93/42/EEC on Medical Devices
Clauses/sub-clauses Essential Requirements (ERs) Qualifying remarks/notes
of this EN of Directive 93/42/EEC
4.2.1, 4.2.2, 4.2.3 7.2 Testing according to 8.8.
The requirement of 4.2.3 (i.e.
2
0,5 μ g /c m /week) is the requirement set
forth by Entry 27 of Annex XVII to REACH.
The test in 8.8 makes reference to
EN 16128 and EN 12472. See also
explanations in Annex D.
4.6 to 4.9 7.3 Testing according to 8.2 to 8.6
4.2.2, 4.2.3 7.5 Testing according to 8.8.
Essential Requirement 7.5 is only partly
addressed in ISO 12870. To the extent that
it is covered in ISO 12870, testing
according to 8.8.
The requirement of 4.2.3 (i.e.
2
0,5 μ g /c m /week) is the requirement set
forth by Entry 27 of Annex XVII to REACH.
The test in 8.8 makes reference to
EN 16128 and EN 12472. See also
explanations in Annex D.
4.8 9.1 Testing according to 8.4 and 8.5.
4.9 9.3 Testing according to 8.6.
9,10 13.1
9,10 13.3 The statement in 10.4 is true
for the countries of the Community
[cf. ER 13.3 a)].
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
4
---------------------- Page: 6 ----------------------
kSIST FprEN ISO 12870:2014
INTERNATIONAL ISO
STANDARD 12870
Third edition
2012-04-01
Ophthalmic optics — Spectacle frames —
Requirements and test methods
Optique ophtalmique — Montures de lunettes — Exigences et
méthodes d’essai
Reference number
ISO 12870:2012(E)
©
ISO 2012
---------------------- Page: 7 ----------------------
kSIST FprEN ISO 12870:2014
ISO 12870:2012(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2012
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO’s
member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2012 – All rights reserved
---------------------- Page: 8 ----------------------
kSIST FprEN ISO 12870:2014
ISO 12870:2012(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 2
4.1 General . 2
4.2 Physiological compatibility . 3
4.3 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
4.9 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 . 9
8.3 Test for resistance to perspiration .10
8.4 Bridge deformation and lens retention test . 11
8.5 Endurance test .13
8.6 Test for resistance to ignition .14
8.7 Test for resistance to optical radiation .15
8.8 Nickel release .16
9 Marking .18
10 Additional information to be supplied by the manufacturer or other person placing the product
on the market .19
11 Reference to ISO 12870 .20
Annex A (informative) Recommendations for the design of spectacle frames .21
Annex B (informative) Examples of layout of test equipment .23
Annex C (informative) Examples of locations for cutting metal spectacle frames before testing for
nickel release .26
Annex D (informative) European requirements and legislation on nickel release.27
Bibliography .28
© ISO 2012 – All rights reserved iii
---------------------- Page: 9 ----------------------
kSIST FprEN ISO 12870:2014
ISO 12870:2012(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 12870 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 7,
Ophthalmic optics and instruments.
This third edition cancels and replaces the second edition (ISO 12870:2004) which has been technically revised.
iv © ISO 2012 – All rights reserved
---------------------- Page: 10 ----------------------
kSIST FprEN ISO 12870:2014
INTERNATIONAL STANDARD ISO 12870:2012(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 referenced documents are indispensable for the application 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 3160-1, Watch cases and accessories — Gold alloy coverings — Part 1: General requirements
ISO 3696:1987, 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, Ophthalmic optics — Spectacle frames — Method for the simulation of wear and detection of
nickel release from coated 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 2012 – All rights reserved 1
---------------------- Page: 11 ----------------------
kSIST FprEN ISO 12870:2014
ISO 12870:2012(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
EXAMPLES Natural horn, bamboo and wood.
NOTE Processing in this case is defined as cutting, shaping, laminating, bonding, bending, polishing and heating.
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 may 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 give essential requirements.
b
“All other frame types” includes plastics and metal spectacle frames, including folding spectacle frames, that have a rim that
completely surrounds the lens periphery.
2 © ISO 2012 – All rights reserved
---------------------- Page: 12 ----------------------
kSIST FprEN ISO 12870:2014
ISO 12870:2012(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 may, 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 existing 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, e.g. 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
2
0,5 μg/cm /week when tested in accordance with 8.8.
The parts to be tested shall include:
— the rear surface of both rims (for full-rim designs, the top part of the rim need not be tested provided the
lower part is tested and the whole rim is manufactured from the same design and material);
— the rear and lower surface of the bridge (except when a non-metallic insert bridge has been fitted), the rear
and upper surface of any brace bar and any other nasal bearing surfaces, including metal nose pads;
— sides, including metal collets, but excluding the joints and the zone immediately around the joints, and
parts intended to be protected by plastics end covers (tips);
— metal decorative trims, if fitted, on the inside of plastics sides and plastics end covers.
Each of these sets of components shall be tested separately for nickel release, and each set shall pass in
order for the frame to pass. If both sides are tested, the results for each side, not their average, shall be used
to determine whether or not the sides pass.
Heads of screws on folding frames, or holding plastics components onto metal frames, that might come into
contact with the skin shall also be tested as part of the front or side to which they are screwed.
© ISO 2012 – All rights reserved 3
---------------------- Page: 13 ----------------------
kSIST FprEN ISO 12870:2014
ISO 12870:2012(E)
Metal frames that are uncoated and made of homogeneous alloys or metals do not require a wear pre-treatment
(such as that speciefi d in 8.8.2) and shall be tested directly in accordance with 8.8.3 or 8.8.4. Unless the manufacturer
certiefi s that a component is homogeneous and uncoated, the component shall be assumed to be coated.
If only indicative information on the extent of nickel release is required, such information can be obtained by
[3]
performing one of the tests specified in CEN/CR 12471:2002 .
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
0
open at ()90 ° to the front or to that part of the side that is attached to the front, and the length is measured
−5
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
4 © ISO 2012 – All rights reserved
---------------------- Page: 14 ----------------------
kSIST FprEN ISO 12870:2014
ISO 12870:2012(E)
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.
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;
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
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.