ISO TS 24348-2014 Ophthalmic optics - Spectacle frames - Method for the simulation of wear and detection of nickel release from metal and combination spectacle .pdf

1、 ISO 2014 Ophthalmic optics Spectacle frames Method for the simulation of wear and detection of nickel release from metal and combination spectacle frames Optique ophtalmique Montures de lunettes Mthode de simulation de lusure et de dtection de la libration du nickel de montures de lunettes en mtal

2、et combines TECHNICAL SPECIFICATION ISO/TS 24348 Third edition 2014-02-01 Reference number ISO/TS 24348:2014(E) ISO/TS 24348:2014(E)ii ISO 2014 All rights reserved COPYRIGHT PROTECTED DOCUMENT ISO 2014 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or

3、utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below or ISOs member body in the country of the requester. ISO cop

4、yright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ISO/TS 24348:2014(E) ISO 2014 All rights reserved iii Contents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references 1 3 Requirem

5、ent . 1 4 Method for the corrosion and abrasion of coated metal spectacle frames before the determination of nickel release 2 4.1 Principle 2 4.2 Reagents and materials . 2 4.3 Sample preparation 5 4.4 Corrosion procedure 6 4.5 Wear procedure 6 4.6 Determination of nickel release . 7 5 Method for th

6、e determination of nickel release 7 5.1 Principle 7 5.2 Materials and reagents . 7 5.3 Apparatus 8 5.4 Samples . 8 5.5 Procedure 9 5.6 Calculations .11 6 Test report 11 Annex A (informative) Statistical uncertainty of the test procedure and interpretation of results 13 Annex B (informative) Rules fo

7、r production and preparation of reference material 15 Annex C (informative) Identification and determination of sample areaand coating of non- significant areas .17 Annex D (informative) Articles made from materials capable of releasing small amounts of nickel .18 Bibliography .19 ISO/TS 24348:2014(

8、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

9、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 matt

10、ers of electrotechnical standardization. The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This do

11、cument was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2. www.iso.org/directives Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such

12、patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received. www.iso.org/patents Any trade name used in this document is information given for the convenience of users and does not co

13、nstitute an endorsement. For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information Th

14、e committee responsible for this document is ISO/TC 172, Optics and photonics, Subcommittee SC 7, Ophthalmic optics and instruments. This third edition cancels and replaces the second edition (ISO/TS 24348:2007), which has been technically revised.iv ISO 2014 All rights reserved ISO/TS 24348:2014(E)

15、 Introduction Adverse skin reaction to nickel has been known for many decades. Nickel is now the most frequent cause of contact allergy, and a significant proportion of the female population is allergic to nickel. Skin absorption of nickel ions, which are released from some nickel-containing materia

16、ls in direct and prolonged contact with the skin, causes sensitization. Further exposure to soluble nickel salts results in allergic contact dermatitis. It is known that sensitization to nickel requires higher exposure levels than does the elicitation in already sensitized individuals. There is a la

17、rge variation in the degree of sensitivity to nickel between individuals. This widespread health problem has forced the introduction of a number of measures designed to reduce its prevalence. They include this Technical Specification which provides two procedures for testing those parts of metal and

18、 combination spectacle frames that come into direct and prolonged contact with the skin. Clause 4 specifies a method for accelerated wear to simulate two years use of coated metal and combination spectacle frames. The coatings might include rolled gold covering, electro- and other plating methods, v

19、arnish and other organic treatments. Clause 5 attempts to provide an in vitro chemical test that correlates as far as possible with the variable human biological reactions that occur when metallic articles containing nickel are in direct and prolonged contact with the skin. It provides a measure of

20、the amount of nickel release from a spectacle frame when immersed for one week in artificial sweat. Clinical patch-testing of a selection of nickel-containing alloys and coatings on nickel-sensitized persons indicates that high and low results achieved with the analytical method in this Technical Sp

21、ecification correspond closely with patch-test reactivity. Moreover, a nickel release rate threshold of 0,5 g/cm 2 / week was set in the European Parliament and Council, originally in Directive 94/27 /EC (OJ No. L188 of 1994-07-22) and transferred to Regulation (EC) 1907 /2006 (OJ No. L396/1 of 2006

22、12-30, REACH). 6In order to ensure that articles yielding values near this figure are not unnecessarily excluded from European trade as a result of the difficulties inherent in the test method, particularly when applied to intricately shaped articles, the measured release figures are multiplied by

23、a factor of 0,1. Materials recognized as causing sensitization to nickel would not become acceptable by use of this adjustment. Application of this Technical Specification is confidently expected to significantly reduce the development of allergic contact dermatitis due to nickel. NOTE Experience of

24、 its use and further epidemiological and clinical research can justify changes to test procedure and/or interpretation of the test result ISO 2014 All rights reserved v Ophthalmic optics Spectacle frames Method for the simulation of wear and detection of nickel release from metal and combination spe

25、ctacle frames 1 Scope This Technical Specification specifies methods for accelerated wear and corrosion, to be used prior to the detection of nickel release from coated metal and combination spectacle frames, and for detecting the release of nickel from those parts of metal and combination spectacle

26、 frames, whether coated or not, intended to come into direct and prolonged contact with the skin, in order to determine whether such parts release nickel at a rate greater than 0,5 g/cm 2 /week. This Technical Specification aims to control those spectacle frames which, if produced with materials and

27、/or surface treatments containing nickel, can be worn by nickel-sensitized persons. 2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable to its application. For dated references, only the edition cited applies. For und

28、ated references, the latest edition of the referenced document (including any amendments) applies. ISO 12870, Ophthalmic optics Spectacle frames Requirements and test methods 3 Requirement Those parts of metal and combination spectacle frames that come into direct and prolonged contact with the skin

29、 of the wearer shall not have a nickel release greater than 0,5 g/cm 2 /week when tested according to this Technical Specification. Spectacle frames having a non-nickel coating shall be subjected to the corrosion and wear pretreatment in Clause 4 which simulate two years typical wear. For spectacle

30、frames that are made of homogeneous alloy or pure metal and are uncoated, go directly to the nickel release test procedure in Clause 5. See also Annex D. 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 brace

31、bar 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 plastic endcovers (tips). TECHNICAL SPECIFICATION ISO/TS 24348:2014(E) ISO 2014 All rights reserved 1 ISO/TS 24348:2014(E

32、) 4 Method for the corrosion and abrasion of coated metal spectacle frames be- fore the determination of nickel release 4.1 Principle The items to be tested are exposed to a corrosive atmosphere before being placed in a tumbling barrel together with a wear medium of abrasive paste and granules. The

33、barrel is rotated so as to subject the test pieces to wear from the wear medium. The items are then tested for nickel release in accordance with Clause 5. 4.2 Reagents and materials 4.2.1 General Except where indicated, all reagents and materials that can come into contact with samples or reagents s

34、hall be demonstrably free of nickel, and all reagents shall be of recognized analytical grade or better. 4.2.2 Reagents and materials for the corrosion procedure 4.2.2.1 Container, with a lid and a device for suspending the test pieces, and all parts made of inert material (e.g. glass or plastic). 4

35、2.2.2 Corrosive medium, prepared by dissolving 50 g DL-lactic acid, 85 % purity, and 100 g sodium chloride in 1 000 ml deionized water. 4.2.2.3 Degreasing solution, being an appropriately diluted, neutral, commercially available detergent, e.g. a 0,5 % aqueous solution of sodium dodecylbenzene sulf

36、onate. 4.2.2.4 Deionized water, specific conductivity maximum 1 S/cm. 4.2.2.5 Laboratory oven, capable of maintaining a temperature of (50 2) C. 4.2.3 Reagents and materials for the wear procedure 4.2.3.1 Tumbling barrel and retaining assembly, in accordance with the following description: barrel of

37、 hexagonal cross-section and internal diameter of 19 cm perpendicular distance between opposite sides designed to rotate around its axis, which is orientated horizontally (see Figure 1); retaining assembly, suitable for attaching the test items so that they do not come into contact with each other d

38、uring tumbling; retaining assembly, with items attached, to be inserted into the barrel for tumbling. NOTE Information on sourcing suitable equipment is available from the ISO Central Secretariat. 4.2.3.2 Rotating system, capable of imparting to the barrel (4.2.3.1) a constant (30 2) rotations per m

39、inute. The rotating system shall be capable of allowing the direction of rotation to be reversed. NOTE Information on sourcing suitable equipment is available from the ISO Central Secretariat.2 ISO 2014 All rights reserved ISO/TS 24348:2014(E) Dimensions in millimetres Key l length of barrel, as req

40、uired a Axis of rotation. Figure 1 View of tumbling barrel 4.2.3.3 Abrasive paste, produced for dry-tumbling barrels and comprising: 6 % to 8 % ester wax of montanic acids Wax E CAS No. 73138-45-1; 3 % octadecanoic acid (stearic acid) CAS No. 57-11-4; 30 % to 35 % petroleum distillates, hydrotreated

41、 light paraffinic CAS No. 64742-55-8; 2 % polyethylene glycol cetyl/oleyl ether CAS No. 68920-66-1 or triethanolamine CAS No. 102-71- 6; 48 % silicon dioxide (quartz) 200 m mesh size CAS No. 14808-60-7; 6 % to 9 % deionized water. NOTE Information on sourcing a suitable paste is available from the I

42、SO Central Secretariat. 4.2.3.4 Granules, composed of outer shells of coconuts, walnuts, peanuts and almonds, mixed in a ratio 1:1:1:1 by weight, ground and sieved to give a mixture of particles having dimensions of between 0,8 mm and 1,3 mm. NOTE Information on sourcing suitable granules is availab

43、le from the ISO Central Secretariat. 4.2.3.5 Wear medium, composed of abrasive paste (4.2.3.3) and wear granules (4.2.3.4) which are mixed as indicated in 4.5.1. Before use, the required amount of granulate shall be conditioned in standard laboratory conditions for at least 24 h. ISO 2014 All rights

44、 reserved 3 ISO/TS 24348:2014(E) 4.2.3.6 Retaining assembly, consisting of a threaded rod which carries three metal hexagonal plates (see Figures 2 and 3). The end plate, A, is drilled part way through with holes of nominal diameter 1,5 mm, or as appropriate, positioned 10 mm to 15 mm from the edge

45、of the plate, to take the ends of the tips of the sides. The next plate, B, is perforated with holes of nominal diameter 5,0 mm, or as appropriate, positioned 10 mm to 15 mm from the edge of the plate, to take the joint ends of the sides, together with an aperture of 40 mm nominal diameter to act as

46、 a filling hole for the abrasive mixture. A silicone rubber sheet with small holes matching the position of those in plate B holds the sides to prevent them from rotating in the assembly. The final plate, C, is undrilled apart from the hole for the threaded rod. A threaded nut on the inside of the l

47、ast two plates holds them the required distance from plate A, while a second nut on the outside clamps the assembly together. The volume between plates A and B is approximately 5 l 0,5 l, but will vary depending upon the length of the sides or width of the spectacle fronts to be tested. Dimensions i

48、n millimetres Figure 2 Plan view of the upper part of the tumbling barrel Component B4 ISO 2014 All rights reserved ISO/TS 24348:2014(E) Key 1 sample side 4 fill hole 2 silicone sheet, perforated 5 adjust as required 3 silicone sheet, plain Figure 3 Exploded diagram of retaining assembly for spectac

49、le sides 4.3 Sample preparation Before being subjected to the corrosion procedure (see 4.4) and the wear procedure (see 4.5), spectacle sides and fronts shall be separated from each other, and endcovers (side tips) removed from sides and nose pads from fronts where appropriate. If the spectacle frame is to be subject to the accelerated wear procedure given in this Technical Specification, then it shall be fitted with test lenses as specified in ISO 12870 before being subject