SIST EN ISO 12870:2009
(Main)Ophthalmic optics - Spectacle frames - Requirements and test methods (ISO 12870:2004)
Ophthalmic optics - Spectacle frames - Requirements and test methods (ISO 12870:2004)
This International Standard specifies fundamental requirements for unglazed spectacle frames designed for use with all prescription lenses, and is applicable to frames at the point of sale to the retailer, by the manufacturer or supplier. It is applicable to all spectacle frame types including rimless mounts, semi-rimless mounts and folding spectacle frames. This International Standard is applicable to spectacle frames made from natural organic materials. 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 12870:2004)
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 Brillenfassung
durch den Hersteller oder Lieferant an den Wiederverkäufer gültig.
Sie gilt für alle Brillenfassungsarten, einschließlich randloser, halb-randloser und zusammenklappbarer
Brillenfassungen. Diese Internationale Norm 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 12870:2004)
L'ISO 12870:2004 spécifie les exigences fondamentales relatives aux montures de lunettes dépourvues de verres conçues pour être équipées de tous les verres de prescription. Elle est applicable sur le point de vente chez le détaillant, par le fabricant ou le fournisseur.
L'ISO 12870:2004 s'applique à tous les types de monture, y compris les montures non cerclées, les montures demi-cerclées, et les montures pliables. Elle est applicable aux matériaux utilisés dans les montures de lunettes fabriquées à partir de substances organiques naturelles.
L'ISO 12870:2004 n'est applicable ni aux montures complètes fabriquées sur mesure, ni aux produits spécifiquement conçus pour assurer une protection individuelle de l'oeil.
Očesna optika - Okviri očal - Zahteve in preskusne metode (ISO 12870:2004)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 12870:2009
01-junij-2009
1DGRPHãþD
SIST EN ISO 12870:2005
SIST EN ISO 12870:2005/AC:2006
2þHVQDRSWLND2NYLULRþDO=DKWHYHLQSUHVNXVQHPHWRGH ,62
Ophthalmic optics - Spectacle frames - Requirements and test methods (ISO
12870:2004)
Augenoptik - Brillenfassungen - Anforderungen und Prüfverfahren (ISO 12870:2004)
Optique ophtalmique - Montures de lunettes - Exigences et méthodes d'essai (ISO
12870:2004)
Ta slovenski standard je istoveten z: EN ISO 12870:2009
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 12870:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 12870:2009
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SIST EN ISO 12870:2009
EUROPEAN STANDARD
EN ISO 12870
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2009
ICS 11.040.70 Supersedes EN ISO 12870:2004
English Version
Ophthalmic optics - Spectacle frames - Requirements and test
methods (ISO 12870:2004)
Optique ophtalmique - Montures de lunettes - Exigences et Augenoptik - Brillenfassungen - Anforderungen und
méthodes d'essai (ISO 12870:2004) Prüfverfahren (ISO 12870:2004)
This European Standard was approved by CEN on 7 March 2009.
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 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 Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 12870:2009: E
worldwide for CEN national Members.
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SIST EN ISO 12870:2009
EN ISO 12870:2009 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4
2
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SIST EN ISO 12870:2009
EN ISO 12870:2009 (E)
Foreword
The text of ISO 12870:2004 has been prepared by Technical Committee ISO/TC 172 “Optics and optical
instruments” of the International Organization for Standardization (ISO) and has been taken over as EN ISO
12870:2009 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 October 2009, and conflicting national standards shall be withdrawn at
the latest by March 2010.
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 12870:2004.
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 93/42/EEC, as
amended by Directive 2007/47/EC.
For relationship with EU Directive 93/42/EEC as amended by Directive 2007/47/EC, 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, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 12870:2004 has been approved by CEN as a EN ISO 12870:2009 without any modification.
3
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SIST EN ISO 12870:2009
EN ISO 12870:2009 (E)
Annex ZA
(informative)
Relationship between this European Standard and the
Essential Requirements of EU Directive 93/42/EEC
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 Communities 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.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.
Table ZA.1 – Correspondence between this European Standard and Directive 93/42/EEC
Clause(s)/sub-clause(s) Essential Requirements (ERs) Qualifying remarks/Notes
of this EN of Directive 93/42/EEC
All this standard. I.1, I.2
4 I.3 Testing according to clauses 5, 6, 7 and 8.
4.2 I.6, II.7.1, II.7.2 Testing according to clause 8.8
4.2 I.6.a) This relevant Essential Requirement is not
addressed in EN ISO 12870.
4.2.2 II.7.5 This relevant Essential Requirement is only partly
addressed in EN ISO 12870; to the extent that it is
covered in EN ISO 12870:
Testing according to clause 8.8;
2
The requirement of 4.2.2 (i. e. 0,5 µg/cm /week is
the requirement set forth by Directive 94/27/EEC.)
The test clause 8.8 makes reference to EN 1811
and ENV 14027.
Note that ENV 14027 has been withdrawn since
the publication of EN ISO 12870:2004. The correct
European Standard to use instead is EN 12472.
4.7 II.7.1 Testing according to clause 8.3
4.8.2 II.7.3, II.9.1 Testing according to clause 8.4
4.9 II.7.1, II.9.3 Testing according to clause 8.6
4.8.3 I.4 Testing according to 8.5
9, 10 II.13.1, II.13.3 ER 13.3 a) is only partly addressed in
EN ISO 12870 (with regard to the identification of
authorized representative).
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
4
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SIST EN ISO 12870:2009
INTERNATIONAL ISO
STANDARD 12870
Second edition
2004-08-01
Corrected version
2004-11-01
Ophthalmic optics — Spectacle frames —
Requirements and test methods
Optique ophtalmique — Montures de lunettes — Exigences et
méthodes d'essai
Reference number
ISO 12870:2004(E)
©
ISO 2004
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SIST EN ISO 12870:2009
ISO 12870:2004(E)
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Published in Switzerland
ii © ISO 2004 – All rights reserved
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SIST EN ISO 12870:2009
ISO 12870:2004(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. 3
4.4 Dimensional tolerances on nominal size. 3
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 . 4
4.9 Resistance to ignition. 5
4.10 Resistance to optical radiation. 5
5 Selection of test samples. 5
5.1 General. 5
5.2 Testing for nickel release. 5
5.3 Change in spectacle frame model. 5
6 Preparation and conditioning of test samples. 6
6.1 Test lenses. 6
6.2 Sample conditioning and test conditions. 6
7 Testing, inspection and compliance . 6
7.1 Testing. 6
7.2 Inspection and examination. 7
7.3 Compliance. 7
8 Test methods. 8
8.1 General. 8
8.2 Test for dimensional stability at elevated temperature. 8
8.3 Test for resistance to perspiration. 9
8.4 Bridge deformation test. 10
8.5 Endurance test . 12
8.6 Test for resistance to ignition. 14
8.7 Test for resistance to optical radiation. 14
8.8 Nickel release . 15
9 Marking. 16
10 Additional information to be supplied by the manufacturer or other person (agent)
placing the product on the market . 17
11 Reference to ISO 12870 . 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) Examples of cutting metal spectacle frames before testing for nickel
release. 25
Bibliography . 26
© ISO 2004 – All rights reserved iii
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SIST EN ISO 12870:2009
ISO 12870:2004(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 second edition cancels and replaces the first edition (ISO 12870:1997), which has been technically
revised. As this International Standard incorporates a revision of the text of ISO 9456:1991 that International
Standard is also cancelled and replaced by the current edition of ISO 12870.
This corrected version of ISO 12870:2004 incorporates the following corrections: Figure B.2 has been modified.
iv © ISO 2004 – All rights reserved
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SIST EN ISO 12870:2009
INTERNATIONAL STANDARD ISO 12870:2004(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, and is applicable to frames at the point of sale to the retailer, by the
manufacturer or supplier.
It is applicable to all spectacle frame types including rimless mounts, semi-rimless mounts and folding
spectacle frames. This International Standard is 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-B02:1994, 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, Optics and optical instruments — Spectacle frames — Vocabulary and lists of equivalent terms
ISO 8596, Ophthalmic optics — Visual acuity testing — Standard optotype and its presentation
ISO 8624, 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 definitions given in ISO 7998 and ISO 8624 and the following apply.
© ISO 2004 – All rights reserved 1
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SIST EN ISO 12870:2009
ISO 12870:2004(E)
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
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 Processing in this case is defined as cutting, shaping, bending, polishing and heating.
NOTE 2 Examples of natural organic materials are natural horn and wood.
3.3
custom-made spectacle frame
spectacle frame made to special order for a named patient
NOTE Examples of custom-made frames are those specially manufactured for wearers with unusual facial
characteristics.
4 Requirements
4.1 General
The requirements applicable to the 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 the different types of spectacle frames
Frame type Subclause (see Note 1)
4.2.1 4.2.2 4.3 4.4 4.5 4.6 4.7 4.8 4.9 4.10
Rimless and semi-rimless mounts g O O O g g g g g O
All other spectacle frames (see
g O g g g g g g g O
Note 2)
Key
g Spectacle frame type shall comply with this subclause in order to pass this International Standard.
O Compliance with this subclause is optional.
4.2.1 General physiological compatibility
4.2.2 Nickel release
4.3 Measurement system
4.4 Dimensional tolerances
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
NOTE 1 Under European legislation, subclauses 4.2.1, 4.2.2, 4.5, 4.6, 4,7, 4.8 and 4.9 give fundamental requirements.
NOTE 2 “All other frame types” includes plastic and metal spectacle frames, including folding spectacle frames, having a rim
completely surrounding the lens periphery.
2 © ISO 2004 – All rights reserved
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SIST EN ISO 12870:2009
ISO 12870:2004(E)
4.2 Physiological compatibility
4.2.1 General physiological compatibility
The manufacturer of spectacle frames shall exclude from contact with the skin, any materials that, amongst a
significant proportion of users, during wear are known to cause irritation, allergic or toxic reaction to skin in a
normal state of health.
NOTE Rare or idiosyncratic reaction to any material may occur and may indicate the need for the individual to avoid
particular types of material. Adverse skin reaction may be due to other causes, e.g. excessive contact pressure.
4.2.2 Nickel release
Those parts of metal and combination spectacle frames which come into direct and prolonged contact with the
2
skin of the wearer shall have a nickel release of less than 0,5 µg/cm /week when tested in accordance with
8.8.
The parts to be tested shall include:
the rear surface of rims;
the rear and lower surface of the bridge, the rear and upper surface of any bracebar and any other nasal
bearing surfaces, including metal nose pads;
sides, excluding the joints and the zone immediately around the joints, and parts intended to be protected
by plastics endcovers (tips).
Metal frames that are uncoated and made of homogeneous alloys or metals do not require a wear pre-
treatment (such as specified in 8.8.2) and shall be tested directly in accordance with 8.8.3.
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 having an accuracy of greater than 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) bridge width: ± 0,5 mm;
d) overall length of side: ± 2,0 mm.
To improve the accuracy of measurement of the overall length of side, it is recommended that the drop should
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, see Figure 1. The overall length
of the 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.
NOTE 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.
© ISO 2004 – All rights reserved 3
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SIST EN ISO 12870:2009
ISO 12870:2004(E)
Figure 1 — Illustration of overall length of side
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 anywhere on the frame, excluding joints and screws, after testing for 8 h and
b) no corrosion, surface degradation or separation of any coating layer on the parts liable to come into
prolonged contact with the skin during wear, i.e. the insides of the sides, bottom and lower parts of the rim
and the inside of the bridge, after testing for a total of 24 h.
Such defects shall be visible under the inspection conditions described in 7.2.
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 between the
boxed centres of the spectacle frame.
4.8.2 Lens retention characteristics
The spectacle frame shall be considered to demonstrate acceptable lens retention characteristics if, when
tested in accordance with 8.4, neither test lens is dislodged wholly or partially from its original location in the
groove or mount.
4 © ISO 2004 – All rights reserved
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SIST EN ISO 12870:2009
ISO 12870:2004(E)
4.8.3 Endurance
When tested in accordance with 8.5, the spectacle frame with the test lenses fitted shall not:
a) fracture at any point;
b) be permanently deformed from its original position by more than 5 mm after 500 cycles;
c) except for frames fitted with sprung joints, require more than light finger pressure to open and close the
sides;
d) for frames that are not fitted with sprung joints, have a side that closes under its own weight at any point
in the opening/closing cycle, or for sides with fitted with sprung joints, the side shall still support its weight
in the open position (i.e. opened to the fullest natural extent without activating the spring mechanism).
4.9 Resistance to ignition
When the spectacle frame is tested in accordance with 8.6, there shall be no continued combustion after
withdrawal of the test rod.
4.10 Resistance to optical radiation
When tested in accordance with 8.7, there shall be no
a) colour change greater than grade 3 of the grey scale in ISO 105-B02:1994, or
b) loss of lustre on bright surfaces,
when compared with an untested sample under the inspection conditions described in 7.2.
5 Selection of test samples
5.1 General
The minimum level of conformity testing requires that two test specimens of each spectacle frame model shall
be selected by an established random sampling technique. These specimens shall be identified as test
sample 1 and test sample 2, and shall be conditioned as described in Clause 6 before testing as described in
Clauses 7 and 8.
5.2 Testing for nickel release
For metal and combination spectacle frames, additional test samples 3 and 4 shall be selected by an
established random sampling technique, and shall be conditioned as described in Clause 6 before testing as
described in 8.8.
5.3 Change in spectacle frame model
If a range of spectacle frame models is made from the same material(s) and with the same manufacturing
procedures including surface treatments, it is acceptable to perform test sequences 3 (subclause 8.3), 7
(subclause 8.6) and, if required, 8 (subclause 8.7) and/or 9 (subclause 8.8) on only one of the spectacle frame
models.
© ISO 2004 – All rights reserved 5
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SIST EN ISO 12870:2009
ISO 12870:2004(E)
6 Preparation and conditioning of test samples
6.1 Test lenses
Prior to testing for the requirements described in 4.6 to 4.10, test samples 1 and 2 shall be fitted with a pair of
suitable test lenses.
NOTE These shall preferably be supplied or specified by the manufacturer. If these are not supplied or specified,
then the following types shall be used depending upon the type of spectacle frame:
1) for rimless frames, organic lenses of polycarbonate with
...
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