BS ISO 12609-1-2013 Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications Specification for products《美容和医学用途的人畜使用强光源.pdf

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1、BSI Standards PublicationBS ISO 12609-1:2013Eyewear for protection againstintense light sources usedon humans and animalsfor cosmetic and medicalapplicationsPart 1: Specification for productsBS ISO 12609-1:2013 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of ISO 12

2、609-1:2013.It supersedes BS 8497-1:2008 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee PH/2, Eye protection.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include al

3、l the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2013. Published by BSI StandardsLimited 2013ISBN 978 0 580 64149 7ICS 13.340.20Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Sta

4、ndard was published under the authority of theStandards Policy and Strategy Committee on 31 August 2013.Amendments issued since publicationDate Text affectedBS ISO 12609-1:2013 ISO 2013Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applicatio

5、ns Part 1: Specification for productsquipements ophtalmiques de protection contre les sources lumineuses intenses utilises sur les animaux et les humains pour des applications mdicales et cosmtiques Partie 1: Spcifications des produitsINTERNATIONAL STANDARDISO12609-1First edition2013-07-15Reference

6、numberISO 12609-1:2013(E)BS ISO 12609-1:2013ISO 12609-1:2013(E)ii ISO 2013 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2013All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanica

7、l, 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 copyright officeCase postale 56 CH-1211 Geneva 20Tel. + 41 22 749 01 11Fax

8、+ 41 22 749 09 47E-mail copyrightiso.orgWeb www.iso.orgPublished in SwitzerlandBS ISO 12609-1:2013ISO 12609-1:2013(E) ISO 2013 All rights reserved iiiContents PageForeword iv1 Scope . 12 Normative references 13 Terms and definitions . 14 Transmittance . 24.1 General . 24.2 F-classification . 24.3 B-

9、classification 34.4 Luminous transmittance 45 Colour recognition 45.1 General . 45.2 Colour of the protective filters. 56 Auto darkening filters . 57 Construction of eye protectors . 67.1 General . 67.2 Frames and side shields 67.3 Materials . 67.4 Adjustment . 67.5 Removal of filters 77.6 Material

10、and surface quality 77.7 Field of view 77.8 Optical properties . 77.9 Resistance to ignition 87.10 Resistance to ageing by UV radiation 87.11 Resistance to thermal ageing 88 Labelling 89 Information to be supplied by the manufacturer . 9Annex A (informative) Filter protection factor (FPF) 10Annex B

11、(informative) Calculation of FPF for protective eyewear Example 1 .12Annex C (informative) Calculation of FPF for protective eyewear Example 2 .15Annex D (informative) Spectral hazard weighting functions .18Annex E (normative) Test method for narrow angle scattering (diffusion of light) 21Annex F (n

12、ormative) Test for resistance to ignition 27Annex G (normative) Test for resistance to ultraviolet radiation .28Annex H (normative) Test for stability at elevated temperature .29Bibliography .30BS ISO 12609-1:2013ISO 12609-1:2013(E)ForewordISO (the International Organization for Standardization) is

13、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 represent

14、ed on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.The procedures used to develop t

15、his document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC

16、Directives, Part 2. www.iso.org/directivesAttention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the developm

17、ent of the document will be in the Introduction and/or on the ISO list of patent declarations received. www.iso.org/patentsAny trade name used in this document is information given for the convenience of users and does not constitute an endorsement.The committee responsible for this document is ISO/

18、TC 94, Personal safety Protective clothing and equipment, Subcommittee SC 6, Eye and face protection.ISO 12609 consists of the following parts, under the general title Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications: Part 1: Speci

19、fication for products Part 2: Guidance for useiv ISO 2013 All rights reservedBS ISO 12609-1:2013INTERNATIONAL STANDARD ISO 12609-1:2013(E)Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications Part 1: Specification for products1 ScopeThi

20、s part of ISO 12609 specifies performance and labelling of eye protectors used for ILS equipment used on humans and animals for cosmetic and medical applications against excessive exposure to optical radiation in the spectral range 250 nm to 3 000 nm, with the exception of laser radiation.This part

21、of ISO 12609 provides a specification for an eye protector expected to cope with the majority of applications. A more rigorous procedure for determining appropriate eye protection against spectral outputs from ILS equipment is described in the annexes.This part of ISO 12609 is not applicable to eye

22、protectors for use with tanning equipment, ophthalmic instruments or other medical/cosmetic devices, the safety issues of which are addressed through other European and International standards.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this docu

23、ment and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) appliesISO 12311:2013, Personal protective equipment Test methods for sunglasses and related equipmen

24、t3 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.3.1blue light hazardpotential for a photochemically induced retinal injury resulting from optical radiation exposure in the wavelength range 300 nm to 700 nm3.2filter protection factorFPFfactor by wh

25、ich the filter attenuates the weighted ocular exposureNote 1 to entry: Mathematical expressions for FPF are given in Annex A and example calculations in Annex B and Annex C.3.3infra-red lens hazardpotential for a thermal injury to cornea and lens of the eye resulting from optical radiation exposure

26、in the wavelength range 780 nm to 3 000 nm ISO 2013 All rights reserved 1BS ISO 12609-1:2013ISO 12609-1:2013(E)3.4intense light sourceILSdevice incorporating one or more non-laser sources of optical radiation of the wavelength range 250 nm to 3 000 nm and intended for creating biological effects in

27、humans and animalsNote 1 to entry: It can operate in a continuous or pulsed regime.3.5retinal thermal hazardpotential for a thermal retinal injury resulting from optical radiation exposure in the wavelength range 380 nm to 1 400 nm3.6ultraviolet hazardpotential for skin and ocular acute and chronic

28、adverse effects resulting from optical radiation exposure in the wavelength range 250 nm to 400 nm4 Transmittance4.1 GeneralThe spectral transmittance of the ILS eye protector at the wavelengths between 250 nm and 3 000 nm shall be specified.The spectral transmittance () of the eye protector materia

29、l shall be determined for normal incidence. The wavelength shall be determined at not more than 10 nm intervals with the central wavelength known to within 2 nm from 250 to 800 nm and within 4 nm above 800 nm. The bandwidth of the detector (full width half maximum) shall not exceed 5 nm.Filters with

30、 angular dependent transmittance shall be measured at angles of incidence between at least 0 and 30.In addition, ILS eyewear may be designated F- or B- scale numbers according to 4.2 and/or 4.3.4.2 F-classificationILS eyewear may be designated F-scale number using the F-classification scheme describ

31、ed in Table 1.NOTE The F-numbers in Table 1 are related to the shade numbers with some relaxation in the infrared region.Luminous transmittance shall be determined according to 4.4.2 ISO 2013 All rights reservedBS ISO 12609-1:2013ISO 12609-1:2013(E)Table 1 Transmittance requirements for general purp

32、ose ILS filtersScale num-berMaximum spectral transmittance in the ultraviolet spectral range()Luminous transmittancevMaximum mean transmittance in the infrared spectral rangeNIR250 nm to 315 nm %315 nm to 380 nm %380 nm to 450 nmMaximum %Minimum %780 nm to 3 000 nm %F-1 0,1 0,4 v100 43,2 50F-2 0,1 0

33、,4 v43,2 17,8 50F-3 0,1 0,4 v17,8 8,5 50F-4 0,1 0,4 v8,5 3,2 50F-5 0,1 0,4 v3,2 1,2 50F-6 0,1 0,4 v1,2 0,44 504.3 B-classificationIn many types of ILS it is the blue component of light that poses the greatest risk. To take account of this, a blue light B-classification scheme described in Table 2 ma

34、y be used.Blue light transmittance Bshould be determined as: BEB dEBd=()()()()()%380550380550100 whereE() is the spectral irradiance of the CIE Standard Illuminant D65, in W m2nm1;B() is blue light hazard weighting function (see Annex D);() is the spectral transmittance of filter material at wavelen

35、gth ; is the wavelength interval of the measurements, in nm. ISO 2013 All rights reserved 3BS ISO 12609-1:2013ISO 12609-1:2013(E)Table 2 Transmittance requirements for blue light ILS filtersScale num-berMaximum spectral transmittance in the ultraviolet spectral range UV()Blue light transmittance BMa

36、ximum mean transmittance in the infrared spectral range NIR()250 nm to 315 nm %315 nm to 380 nm %380 nm to 450 nmMaximum %Minimum %780 nm to 3 000 nm %B-1 0,1 0,4 B100 43,2 50B-2 0,1 0,4 B43,2 17,8 50B-3 0,1 0,4 B17,8 8,5 50B-4 0,1 0,4 B8,5 3,2 50B-5 0,1 0,4 B3,2 1,2 50B-6 0,1 0,4 B1,2 0,44 504.4 Lu

37、minous transmittanceThe luminous transmittance Vof the protective filters intended for use by the ILS operator shall be determined as: VEV dEVd=()()()()()380780380780whereE() is the spectral irradiance of the CIE Standard Illuminant D65, in W m2nm1;V() is spectral luminous efficiency; is the wavelen

38、gth interval of the measurements, in nm;() is the spectral transmittance of filter material at wavelength .NOTE There are no requirements for the luminous transmittance of the filters of eye protectors intended for use by ILS equipment patients/clients; these filters may be opaque.5 Colour recogniti

39、on5.1 GeneralThere are no requirements for colour neutrality.If colour neutrality is claimed, spectral transmittance between 450 nm and 650 nm shall be uniform within 20 % of the mean transmittance value in this range.4 ISO 2013 All rights reservedBS ISO 12609-1:2013ISO 12609-1:2013(E)5.2 Colour of

40、the protective filtersThe Commission Internationale de LEclairage (CIE) colour coordinates (x, y) of the protective filters intended for use by the ILS operator shall be determined as:xXXYZ=+andyYXYZ=+whereXExd= ()()()380780YEyd= ()()()380780ZEzd= ()()()380780andxy z,andare CIE colour matching funct

41、ions;E() is the spectral irradiance of the CIE Standard Illuminant D65, in W m2nm1; is the wavelength interval of the measurements, in nm;() is the spectral transmittance of filter material at wavelength .NOTE 1 The colour coordinates (x, y) of the protective filters might be optionally presented on

42、 a CIE chromaticity chart.NOTE 2 There are no requirements for the colour perception of the filters of eye protectors intended for use by ILS equipment patients/clients; these filters may be opaque.6 Auto darkening filtersAuto darkening filters shall provide the required levels of IR and UV protecti

43、on specified in Tables 1 and 2 in light and dark states.In the case of protective filters that exhibit a change of luminous transmittance in response to an exposure to incident optical radiation, the time taken by the eye protector to reach 3x the minimum luminous transmittance (“dark state”) shall

44、be determined.Auto darkening filters powered by mains, batteries or photoelectric cells shall reduce the luminous transmittance (380 nm to 780 nm) to maximum of 30 % if the power supply is disconnected or malfunctions.The minimum luminous transmittance in the light and dark states of auto darkening

45、filters shall be specified, for the angles of incidence at least between 0 and 30. ISO 2013 All rights reserved 5BS ISO 12609-1:2013ISO 12609-1:2013(E)7 Construction of eye protectors7.1 GeneralMirror-finish or metalized finishes on filters or frames shall not be used.NOTE Secondary reflections from

46、 frames or filters of protective eyewear, especially from concave surfaces, might increase the risk of uncontrolled exposure of the users.7.2 Frames and side shieldsFrames and side shields through which exposure to incident optical radiation could occur to the eyes shall give at least the same prote

47、ction as the filters and shall be designed to prevent the leakage of optical radiation around the edges of protective eyewear.7.3 MaterialsWhen assessed in accordance with visual inspection, for those parts of the eye protector that come into contact with the skin, materials shall not be used which

48、are known to be likely to cause skin irritation or any adverse effect on health.Substances recommended for cleaning, maintenance or disinfection shall have no adverse effect on the eye protector and shall be known not to be likely to have any adverse effect upon the wearer, when applied in accordanc

49、e with the eye protector manufacturers instructions.Information claiming that the product is innocuous shall be examined.The following are examples of documents that shall be provided for examination: materials specifications; 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; in