Dentistry - Periodontal probes - Part 1: General requirements (ISO 21672-1:2012)

1 Scope
This part of ISO 21672 specifies general requirements and test methods for periodontal probes.
It is applicable to periodontal probes made of austenitic and martensitic stainless steel.
It is not applicable to periodontal probes with working ends made completely of plastics, nor to HAUER probes and periodontal probes with a defined probing force.

Zahnheilkunde - Parodontalsonden - Teil 1: Allgemeine Anforderungen (ISO 21672-1:2012)

1   Anwendungsbereich
Dieser Teil von ISO 21672 legt allgemeine Anforderungen und Prüfverfahren für Parodontalsonden fest.
Er gilt für Parodontalsonden, die aus austenitischem und martensitischem nicht rostendem Stahl hergestellt wurden.
Er gilt nicht für Parodontalsonden, deren Arbeitsenden vollständig aus Kunststoff gefertigt sind, nicht für HAUER-Parodontalsonden und auch nicht für Parodontalsonden mit einer festgelegten Sondierungskraft.

Médecine bucco-dentaire - Sondes parodontales - Partie 1: Exigences générales (ISO 21672-1:2012)

1 Domaine d'application
La présente partie de l'ISO 21672 spécifie les exigences générales et les méthodes d'essai applicables aux sondes parodontales.
Elle s'applique aux sondes parodontales réalisées en acier inoxydable austénitique et martensitique.
Elle ne s'applique pas aux sondes parodontales munies d'extrémités actives réalisées entièrement en matière plastique, ni aux sondes HAUER ni aux sondes parodontales ayant une force de sondage définie.

Zobozdravstvo - Periodontalne sonde - 1. del: Splošne zahteve (ISO 21672-1:2012)

Ta del standarda ISO 21672 določa splošne zahteve in preskusne metode za periodontalne sonde. Velja za periodontalne sonde, narejene iz avstenitnega in martenzitnega nerjavnega jekla.

General Information

Status
Published
Publication Date
31-Mar-2012
Withdrawal Date
30-Oct-2012
Technical Committee
CEN/TC 55 - Dentistry
Drafting Committee
CEN/TC 55 - Dentistry
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
01-Apr-2012
Completion Date
01-Apr-2012

Relations

Effective Date
28-Jan-2026
Effective Date
28-Jan-2026

Overview

EN ISO 21672-1:2012 - Dentistry - Periodontal probes - Part 1: General requirements (ISO 21672-1:2012) specifies the general requirements and test methods for periodontal probes. Adopted by CEN as a European Standard, it applies specifically to periodontal probes manufactured from austenitic and martensitic stainless steel. The standard does not apply to probes whose working ends are entirely plastic, to HAUER probes, or to probes with a defined probing force.

Key topics

This part of ISO 21672 focuses on high-level, safety- and performance-related elements typical for dental instrument standards:

  • Scope and applicability - materials covered (austenitic and martensitic stainless steel) and explicit exclusions (plastic working ends, HAUER probes, probes with defined probing force).
  • General requirements - baseline expectations for design, material selection and manufacture to ensure safe clinical use.
  • Test methods - standardized procedures for verifying compliance with the general requirements (selection and preparation of test samples, conditioning, inspection and testing).
  • Compliance and conformity - guidance for manufacturers and testing bodies to demonstrate that instruments meet the standard.

(Exact test procedures, limits and pass/fail criteria are defined in the standard text and should be consulted for implementation.)

Applications

EN ISO 21672-1:2012 is practical for organizations and stakeholders involved in the lifecycle of periodontal probes:

  • Manufacturers and product designers - to design and produce stainless-steel periodontal probes that meet recognized safety and performance expectations.
  • Quality and regulatory teams - to develop test protocols, quality control checks and technical documentation demonstrating conformity for CE or national market entry.
  • Testing laboratories - to adopt standardized test methods for instrument evaluation and certification.
  • Procurement and clinical managers - to specify compliant periodontal probes in tenders and purchasing specifications.
  • Dental professionals and educators - to understand the design and safety basis for commonly used stainless-steel periodontal probes.

Related standards

EN ISO 21672-1:2012 is part of the international standardization work for dental instruments under ISO/TC 106 and has been adopted by CEN. For full technical requirements, referenced normative documents and any additional parts in the ISO 21672 series (if published), consult the official ISO/CEN publications.

Keywords: periodontal probe standard, EN ISO 21672-1:2012, dental instrument requirements, periodontal probe test methods, stainless steel periodontal probes, CEN dentistry standard.

Standard

EN ISO 21672-1:2012

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Frequently Asked Questions

EN ISO 21672-1:2012 is a standard published by the European Committee for Standardization (CEN). Its full title is "Dentistry - Periodontal probes - Part 1: General requirements (ISO 21672-1:2012)". This standard covers: 1 Scope This part of ISO 21672 specifies general requirements and test methods for periodontal probes. It is applicable to periodontal probes made of austenitic and martensitic stainless steel. It is not applicable to periodontal probes with working ends made completely of plastics, nor to HAUER probes and periodontal probes with a defined probing force.

1 Scope This part of ISO 21672 specifies general requirements and test methods for periodontal probes. It is applicable to periodontal probes made of austenitic and martensitic stainless steel. It is not applicable to periodontal probes with working ends made completely of plastics, nor to HAUER probes and periodontal probes with a defined probing force.

EN ISO 21672-1:2012 is classified under the following ICS (International Classification for Standards) categories: 11.060.25 - Dental instruments. The ICS classification helps identify the subject area and facilitates finding related standards.

EN ISO 21672-1:2012 has the following relationships with other standards: It is inter standard links to EN 4165-023:2007, EN 474-5:2006+A1:2009+A2:2012. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

EN ISO 21672-1:2012 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.

EN ISO 21672-1:2012 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.

Standards Content (Sample)


SLOVENSKI STANDARD
01-september-2012
Zobozdravstvo - Periodontalne sonde - 1. del: Splošne zahteve (ISO 21672-1:2012)
Dentistry - Periodontal probes - Part 1: General requirements (ISO 21672-1:2012)
Zahnheilkunde - Parodontalsonden - Teil 1: Allgemeine Anforderungen (ISO 21672-
1:2012)
Médecine bucco-dentaire - Sondes parodontales - Partie 1: Exigences générales (ISO
21672-1:2012)
Ta slovenski standard je istoveten z: EN ISO 21672-1:2012
ICS:
11.060.25 =RERWHKQLþQLLQVWUXPHQWL Dental instruments
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 21672-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2012
ICS 11.060.25
English Version
Dentistry - Periodontal probes - Part 1: General requirements
(ISO 21672-1:2012)
Médecine bucco-dentaire - Sondes parodontales - Partie 1: Zahnheilkunde - Parodontalsonden - Teil 1: Allgemeine
Exigences générales (ISO 21672-1:2012) Anforderungen (ISO 21672-1:2012)
This European Standard was approved by CEN on 31 March 2012.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same
status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 21672-1:2012: E
worldwide for CEN national Members.

Contents Page
Foreword .3

Foreword
This document (EN ISO 21672-1:2012) has been prepared by Technical Committee ISO/TC 106 “Dentistry” in
collaboration with Technical Committee CEN/TC 55 “Dentistry” 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 2012, and conflicting national standards shall be withdrawn at
the latest by October 2012.
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.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 21672-1:2012 has been approved by CEN as a EN ISO 21672-1:2012 without any
modification.
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
ISO 12870:2012(E)
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

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 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

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 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

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
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 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
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

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 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.
4.8.3 Endurance
When tested in accordance with 8.5, the spectacle frame with the test lenses fitted shall not:
a) fracture at any point;
ISO 12870:2012(E)
b) be permanently deformed from its original position by more than 5 mm after 500 cycles;
c) require more than light finger pressure to open and close the sides (except for frames fitted with sprung joints);
d) have a side that closes under its own weight at any point in the opening/closing cycle (for frames not fitted
with sprung joints), or for sides 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 on the grey scale in ISO 105-A02, 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 at random. These specimens shall be selected by the manufacturer or its representative, and shall
be identified as test sample 1 and test sample 2. They shall be conditioned as described in Clause 6 before
testing as described in Clauses 7 and 8.
In some regions, local legislation requires a spectacle frame model to comply with regulatory requirements
throughout the duration of its supply to the market. When compliance with this International Standard is claimed,
the manufacturer or its representative has the responsibility, by any chosen means, e.g. use of ISO 13485,
ISO 14971 and/or this International Standard, to ensure that the compliance of the spectacle frame model
continues throughout its duration of supply, and not only at its first launch on the market.
5.2 Testing for nickel release
For metal and combination spectacle frames, two additional test samples 3 and 4 shall be selected at random
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), following the same manufacturing
procedures, including surface treatments, it is acceptable to perform, from Table 2, test sequences 4 (see 8.3),
8 (see 8.6) and, if required, 9 (see 8.7) and/or 10 (see 8.8) on only one of the spectacle frame models.
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.
6 © ISO 2012 – All rights reserved

ISO 12870:2012(E)
The test lenses 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:
a) for rimless frames, organic lenses of polycarbonate with a vertex power of 0,00 D ± 0,25 D, a centre
thickness of 2,00 mm ± 0,2 mm and a radius of curvature of the concave surface of 90 mm ± 10 mm;
1)
b) for semi-rimless frames, organic lenses of allyl diglycol carbonate or polycarbonate with a vertex power
of 0,00 D ± 0,25 D, a centre thickness of 2,00 mm ± 0,2 mm and a radius of curvature of the concave
surface of 90 mm ± 10 mm;
c) for all other frame types, including folding and all rimmed spectacles, either organic lenses as in b) above,
or silicate glass with a vertex power of 0,00 D ± 0,25 D, a centre thickness of 2,25 mm ± 0,25 mm and a
radius of curvature of the concave surface of 100 mm ± 20 mm.
Prior to any wear pre-treatment for nickel release as specified in 4.2.3, test samples 3 and 4 shall, if they are
not already fitted with dummy or demonstration lenses, be fitted with a pair of suitable organic lenses within the
range of −1,00 D to +1,00 D and with an edge thickness of between 1,5 mm and 2,5 mm.
For all test samples, these test lenses shall be edged either in accordance with the manufacturer’s electronic
instructions or with a digitally controlled edging machine that uses the tracing made of the individual test
sample or, where appropriate, using a mechanical former in accordance with ISO 11380.
+3
The bevel angle of the edged lens shall be ()120 ° for spectacle frames featuring a rim with a groove.
−2
6.2 Sample conditioning and test conditions
Immediately before starting the series of tests, the test samples shall be conditioned for at least 4 h at an
ambient temperature of 23 °C ± 5 °C, in the condition as received from the manufacturer or supplier, without
prior realignment, adjustment or lubrication.
Carry out the testing in an atmosphere maintained within the same temperature range.
7 Testing, inspection and compliance
7.1 Testing
The testing shall be carried out with the conditioned test samples (see 6.2) in the sequence specified in Table 2
at an ambient temperature of 23 °C ± 5 °C.
1) A trade name for this polymer is CR 39. This information is given for the convenience of users of this International
Standard and does not constitute an endorsement by ISO of the product named. Equivalent products may be used if they
can be shown to lead to the same results.
ISO 12870:2012(E)
Table 2 — Sequence of testing
Requirement Test method Samples
Identification of test Sequence Sample 1 Sample 2
subclause subclause 3 and 4
Construction 4.2.1 4.2.1 1 ∗
Dimensional tolerance 4.3; 4.4 4.4 2 ∗
Dimensional stability 4.6 8.2 3 ∗
Resistance to perspiration 4.7 8.3 4 ∗
Bridge deformation 4.8.1 8.4 5 ∗
Lens retention 4.8.2 8.4 6 ∗
Endurance 4.8.3 8.5 7 ∗
Resistance to ignition 4.9 8.6 8 ∗
a
Resistance to optical radiation 4.10 8.7 9 ∗
b
Nickel release 4.2.3 8.8 10 ∗

Indicates that the test shall be applied.
a
This test is optional.
b
This test is a legal requirement in some countries.
7.2 Inspection and examination
Where visual inspection is required, the inspection and examination of test samples shall be carried out,
without the aid of a magnifying lens, by an observer with a visual acuity of at least 1,0, when tested using
optotypes conforming to ISO 8596. Any visual correction required for the observation distance shall be worn.
During the examination, expose the test specimen to an illuminance of 1 000 lx to 2 000 lx and carry out the
inspection against a matt black background.
7.3 Compliance
If all test samples of the spectacle frame model pass the tests specified in Table 1 and listed in Table 2, the
product shall be deemed to comply with this International Standard (see Figure 2).
If either sample 1 or sample 2 fails any one of the tests in the complete test sequence, an additional sample
shall be used to repeat the test that was failed. If this additional sample passes the previously failed test and
subsequent tests specified in Table 1 and listed in Table 2, the product shall be deemed to comply with this
International Standard. If one or more tests in the sequence result in failure, the product shall be deemed not
to comply with this International Standard.
If two or more of the tests carried out on the first set of test samples result in failure, no additional samples shall
be tested and the product shall be deemed not to comply with this International Standard.
In the case of non-compliance, this clause does not preclude resubmitting the frame for testing after
improvements have been made to its design or manufacture.
8 © ISO 2012 – All rights reserved

ISO 12870:2012(E)
Figure 2 — Flow chart for compliance, excluding testing for nickel release
8 Test methods
8.1 General
The test methods described are reference test methods. Variations or alternatives may be used provided their
results can be shown to be equivalent to those of the relevant reference method. In case of dispute, the result
obtained with the reference method shall have precedence.
8.2 Test for dimensional stability at elevated temperature
8.2.1 Apparatus
8.2.1.1 Oven, capable of producing the test temperature of 55 °C ± 5 °C.
8.2.1.2 Flat plate, of glass or metal, mounted in the oven (8.2.1.1) either on, or parallel to, the base of the chamber.
8.2.1.3 Linear measuring device, having a measuring accuracy of at least 0,5 mm.
ISO 12870:2012(E)
8.2.2 Procedure
8.2.2.1 At an ambient temperature of 23 °C ± 5 °C, take test sample 1, with test lenses fitted and with the sides
open to the fullest extent (for frames with sprung joints, opened to the fullest natural extent without activating
the spring mechanism), and measure the distance between the side tips using the measuring device (8.2.1.3).
Record this measurement as the pre-heating value, l .
8.2.2.2 Before commencing the test, stabilize the oven (8.2.1.1) at the test temperature of 55 °C ± 5 °C.
Place the test sample on the plate (8.2.1.2), with the sides still open to the fullest extent, and with the top edge
of the front and the top edge of the sides resting on the plate surface. Place the sample on the plate in the oven,
and ensure that the sample does not touch other samples or the oven wall.
8.2.2.3 When the test sample has reached the test temperature after approximately 15 min at the appropriate
+5min
setting, leave it undisturbed at the test temperature for a further 2 h .
0min
After this period, remove the test sample, still on the plate, from the oven. Allow to cool for a period of at least
2 h at 23 °C ± 5 °C and repeat the measurement of the distance between the side tips as described in 8.2.2.1.
Record this measurement as the post-heating value, l , and calculate the difference l − l .
1 1 0
8.3 Test for resistance to perspiration
8.3.1 Apparatus and reagents
8.3.1.1 Oven, capable of producing the test temperature of 55 °C ± 5 °C.
8.3.1.2 Container, of glass or inert plastic, measuring at least 200 mm across and 90 mm high, capable of
being closed.
8.3.1.3 Volumetric flask, 1 l, gauged to class A.
8.3.1.4 Water, conforming to grade 3 of ISO 3696.
8.3.1.5 Artificial sweat solution, comprising:
a) lactic acid, r = 1,21 g/ml, >85 % purity;
b) sodium chloride (analytical reagent purity, ≥99 %);
Impurities:
1) Pb: ≤0,001 0 %;
2) Fe: ≤0,001 0 %;
3) Br: ≤0,020 0 %;
4) I: ≤0,010 0 %;
c) water, conforming to grade 3 of ISO 3696.
Using suitable containers, weigh 50 g ± 0,1 g of lactic acid and 100 g ± 0,1 g of sodium chloride and dissolve in
900 ml of water. Using the flask (8.3.1.3), make up to 1 l with water.
8.3.1.6 Frame supports, of glass or inert plastic, fitted in the container so that the sample(s) are held above
the artificial sweat solution (see Figure B.1). The supports may be designed so as to hold several samples
stacked one above another, or side by side, or both, but without being in contact with each other.
10 © ISO 2012 – All rights reserved

ISO 12870:2012(E)
8.3.2 Procedure
8.3.2.1 Cover the base of the container (8.3.1.2) with the artificial sweat solution (8.3.1.5) to a minimum depth
of 10 mm so that the lowest part of the (lowest, if stacked) frame shall be not less than 12 mm above the solution.
Place test sample 1, fitted with the test lenses, on the supports (8.3.1.6), with the sides open to the fullest extent
(for frames with sprung hinges, opened to the fullest natural extent without activating the spring mechanism),
and with the bottom edges of the sides resting on the supports (see Figure B.1). Ensure that the spectacle
frame does not touch other samples or the container walls.
Close the container, place it in the oven (8.3.1.1) and maintain at 55 °C ± 5 °C.
8.3.2.2 After 8 h ± 30 min, remove each sample and immediately wash with water (8.3.1.4). Dry without
rubbing, using a soft cloth.
8.3.2.3 Within 30 min, examine each test sample without the aid of magnification under the inspection
conditions described in 7.2. By comparison with an identical untested spectacle frame, check for and record any
spots or change in colour.
8.3.2.4 Replace the test samples on the supports, close the container and maintain the test temperature
of 55 °C ± 5 °C for a further 16 h ± 30 min. After completion of this second period, remove, clean and dry the
samples as described in 8.3.2.2.
8.3.2.5 Within 30 min, examine those areas of each sample which are liable to come into prolonged contact with
the skin of the wearer under the inspection conditions described in 7.2. By comparison with an identical untested
spectacle frame, check for and record any corrosion, surface degradation or separation of any coating layer.
8.4 Bridge deformation and lens retention test
8.4.1 Apparatus (see Figure 3)
The test apparatus consists of a vertically operating annular clamp, a downward-operating pressure peg and
a measuring device. The annular clamp shall be capable of holding the test sample without twist or slip and
have a diameter of 25 mm ± 2 mm, with two contact surfaces, E and E , made of a firm elastic material
1 2
(e.g. polyamide). The downward-operating pressure peg (see Figure 3, key item 5) shall have a diameter of
10 mm ± 1 mm with an almost hemispherical contact surface. The clamping surfaces can be separated at least
10 mm on either side of a horizontal line going through the apparatus and the pressure peg can travel from at
least 10 mm above the horizontal line to not more than 8 mm below. To accommodate frames with a significant
face form angle, the annular clamp shall also be capable of rotating about a horizontal axis so that the axis of
the pressure peg remains perpendicular to the plane of the unclamped lens at its boxed centre. The distance
between the clamp and pressure peg is adjustable. The apparatus includes a linear measuring device that is
accurate to at least 0,1 mm.
ISO 12870:2012(E)
Dimensions in millimetres
Key
1 measuring device
2 annular clamp
3 direction and point of application of force (maximum 5 N)
4 travelling ring
5 pressure peg
Figure 3 — Bridge deformation test
8.4.2 Procedure
8.4.2.1 Mount test sample 2 on the device with the sides of the test sample extended and with the front of the
test sample downwards. Clamp the sample within 2 mm of the boxed centre of one lens (see Figure 3).
Lower the pressure peg so that it rests on the back surface of the unclamped lens within 2 mm of its boxed
centre, ensuring that there is no movement of the lens. Record this as the starting position.
Then move the pressure peg downwards slowly and smoothly, increasing the force until the first of either of the
following criteria is reached:
a) a maximum force of 5 N;
b) a distance equal to (10 ± 1) % of the boxed centre distance, c (see ISO 8624).
8.4.2.2 If the maximum force of 5 N is insufficient to displace the pressure peg over the distance specified in
8.4.2.1 b), continue the test but record the displacement that was attained.
Retain the initial displacement for 5 s, then return the pressure peg to its starting position. After a relaxation
period of 20 s, lower the pressure peg again until it just rests on the lens.
8.4.2.3 Determine, in millimetres, the movement, x, of the pressure peg from the starting position and calculate
the percentage deformation using the following formula. Check that the spectacle frame shows no fracture.
12 © ISO 2012 – All rights reserved

ISO 12870:2012(E)
x
f =×100
c
where
f is the percentage deformation;
x is the movement of the pressure peg;
c is the boxed centre distance.
8.4.2.4 Using the inspection conditions described in 7.2, check that neither test lens has been dislodged
wholly or partially from its original location in the groove or mount.
8.5 Endurance test
8.5.1 Apparatus
The test apparatus consists of two clamping devices mounted on universal joints, which are used to restrain
the sides (see Figures B.2 and B.3), and a horizontal bar forming a bridge support (see Figure 4, item 2). The
bridge support has a triangular cross-section, enclosing an angle of 30° ± 2° and having a thickness at the top
of 12 mm ± 1 mm with the upper edge approximately radiused.
The positions of the clamps and bridge support, relative to each other, are adjustable by at least 40 mm
horizontally and v
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