1、BSI Standards PublicationBS ISO 12609-2:2013Eyewear for protection againstintense light sources usedon humans and animalsfor cosmetic and medicalapplicationsPart 2: Guidance for useBS ISO 12609-2:2013 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of ISO 12609-2:2013
2、.It supersedes BS 8497-2:2008 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee PH/2, Eye protection.A list of organizations represented on this committee can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 all the nece
3、ssaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2013. Published by BSI StandardsLimited 2013ISBN 978 0 580 64150 3ICS 13.340.20Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was
4、published under the authority of theStandards Policy and Strategy Committee on 31 August 2013.Amendments issued since publicationDate Text affectedBS ISO 12609-2:2013 ISO 2013Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications Part 2:
5、 Guidance for usequipements ophtalmiques de protection contre les sources lumineuses intenses utilises sur les animaux et les humains pour des applications mdicales et cosmtiques Partie 2: Directives dutilisationINTERNATIONAL STANDARDISO12609-2First edition2013-07-15Reference numberISO 12609-2:2013(
6、E)BS ISO 12609-2:2013ISO 12609-2:2013(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 mechanical, including photocopyi
7、ng, 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 + 41 22 749 09 47E-mail
8、 copyrightiso.orgWeb www.iso.orgPublished in SwitzerlandBS ISO 12609-2:2013ISO 12609-2:2013(E) ISO 2013 All rights reserved iiiContents PageForeword iv1 Scope . 12 Terms and definitions . 13 Optical radiation hazards 23.1 Risk assessment . 23.2 Control measures 24 Eye protection 34.1 Protective eyew
9、ear 34.2 Filter protection factor (FPF) . 34.3 Luminous transmittance and colour perception . 45 User comfort and secondary safety issues 45.1 Peripheral leakage . 45.2 Secondary reflections from eyewear frame and filters 45.3 Quality of filters and clarity of vision 45.4 Exposure to bright flashes
10、below ELVs 45.5 Overheating of eyewear 55.6 Additional considerations for auto darkening filters 5Annex A (informative) Ocular exposure to optical radiation 6Annex B (informative) Retinal thermal hazard Assessment flowchart . 7Annex C (informative) Retinal thermal hazard Example calculation 8Annex D
11、 (informative) Protective eyewear for the patient/client 12Annex E (informative) Protective eyewear for the operator .13Annex F (informative) Filter protection factor .14Annex G (informative) Luminous transmittance 16Annex H (informative) Colour perception of ILS protective eyewear Example 17Bibliog
12、raphy .18BS ISO 12609-2:2013ISO 12609-2:2013(E)ForewordISO (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 mem
13、ber 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 El
14、ectrotechnical Commission (IEC) on all matters 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
15、 of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC 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 res
16、ponsible for identifying any or all such 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/patentsAny trade name used in this document is information given for
17、the convenience of users and does not constitute an endorsement.The committee responsible for this document is ISO/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 prote
18、ction against intense light sources used on humans and animals for cosmetic and medical applications: Part 1: Specification for products Part 2: Guidance for useiv ISO 2013 All rights reservedBS ISO 12609-2:2013INTERNATIONAL STANDARD ISO 12609-2:2013(E)Eyewear for protection against intense light so
19、urces used on humans and animals for cosmetic and medical applications Part 2: Guidance for use1 ScopeThis International Standard gives guidance and information to users, manufacturers, suppliers, and safety advisors on the selection and use of eye protectors for intense light source (ILS) equipment
20、 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 International Standard provides guidance on selection of an eye protector expected to cope with the m
21、ajority of applications and a more rigorous procedure for determining appropriate eye protection against spectral outputs from ILS equipment.This International Standard is not applicable to eye protectors for use with tanning equipment, ophthalmic instruments, or other medical/cosmetic devices, the
22、safety issues of which are addressed through other European and International Standards.2 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.2.1attenuationdecrease in the irradiance or radiant exposure as optical radiation passes through an absorbing or
23、 scattering medium2.2exposure limit valuesELVslevel of exposure to the eye or skin that is not expected to result in adverse biological effects2.3intense 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
24、 creating biological effects in humans and animalsNote 1 to entry: It can operate in continuous or pulsed regime.2.4ocular hazard distanceOHDdistance at which the beam irradiance, radiance, or radiant exposure equals the appropriate ocular ELVs2.5pulse durationtime increment measured between the hal
25、f peak (50 %) of power points at the leading and trailing edges of a pulse ISO 2013 All rights reserved 1BS ISO 12609-2:2013ISO 12609-2:2013(E)2.6pulse separationtime between the end of one pulse and the onset of the following pulse, measured at the 50 % trailing and leading edges2.7skin hazard dist
26、ancedistance at which the beam irradiance or radiant exposure equals the appropriate skin ELVs3 Optical radiation hazards3.1 Risk assessment3.1.1 The eye is at risk of injury from optical radiation in excess of the exposure limit values (ELVs) (see Annex A). A comparison of the predicted or measured
27、 radiation exposure with the applicable ELVs allows an assessment of a personal workplace exposure to optical radiation.3.1.2 The risk assessment should include the following.a) Determine the ELVs for exposure duration, type of hazard, and emitting device configuration.b) Determine the likely exposu
28、re level from the ILS taking account of the exposure scenario, e.g. expected use or foreseeable fault conditions.c) Compare the likely exposure levels with the ELVs.3.1.3 If other measures are insufficient or inadequate to control the risk of eye exposure in excess of any applicable ELVs, eye protec
29、tion should be worn. The appropriate F-#, B-#, and/or filter protection factor should be determined at a distance of 200 mm from the ILS. If such eye protection is not available, a calculation using measured spectrally weighted radiance or irradiance has to be carried out in order to verify the suit
30、ability of a specific eyewear for a specific ILS source.NOTE Personnel who might be at risk include the patient/client, ILS equipment operator, assisting staff, and others.3.1.4 See Annex B for a retinal thermal hazard assessment and Annex C for a worked example calculation.3.2 Control measures3.2.1
31、 Any person who is present within the ocular and skin hazard distance should be protected against eye or skin exposure to optical radiation above any applicable ELVs.3.2.2 The extent of the skin and ocular hazard distance might vary according to the type of ILS equipment used and the optical propert
32、ies of the output optics attachments.3.2.3 Exposure to optical radiation should be reduced, as far as reasonably practicable, by means of physical safeguards, such as engineering controls. Personal protection should only be used when engineering and administrative controls are impracticable or incom
33、plete, in accordance with Figure 1.2 ISO 2013 All rights reservedBS ISO 12609-2:2013ISO 12609-2:2013(E)Hierarchy of control measuresEngineering controlsAdministrative controlsPersonal protective equipmentContainmentEnclosuresInterlocksHousingScreensAssessment of hazardsLocal rules and proceduresCont
34、ingency plansSupervisionTrainingAccess controlFigure 1 Hierarchy of control measures4 Eye protection4.1 Protective eyewear4.1.1 Reduction of unintended exposure should be included in the design specifications of the ILS equipment. Exposure to optical radiation should be reduced, as far as reasonably
35、 practicable, by means of physical safeguards, such as engineering controls.4.1.2 When the treatment region is close to the eye, the patients or clients protective eyewear should be selected carefully, as there will be a significant risk of exposure in excess of the ELVs. Consideration should also b
36、e given to the good fit of safety eyewear to prevent penetration of optical radiation from around the frame.4.1.3 Different types of eye protection might be required for patients/clients, ILS equipment operators, and supporting personnel.4.1.4 An unambiguous and robust method of marking the ILS prot
37、ective eyewear should be employed to ensure that there is a clear link to the particular ILS equipment device for which it has been specified, and to facilitate this, a simplified classification scheme has been introduced.4.1.5 A checklist to help select protective eyewear for the patient/client is
38、given in Annex D.4.1.6 A checklist to help select protective eyewear for the operator is given in Annex E.4.2 Filter protection factor (FPF)4.2.1 ELVs should be used to determine the required attenuation level of ILS protective filters because they refer to effective, i.e. spectrally weighted, value
39、s.4.2.2 Optical density or shade numbers should not be used for the characterization of ILS protective filters as they do not take into account the difference in the effect of different wavelengths on the eye.4.2.3 FPF is a factor by which the protective filter attenuates the weighted ocular exposur
40、e. If the risk assessment demonstrates that ocular exposure limits are exceeded, the FPF of the protective eyewear ISO 2013 All rights reserved 3BS ISO 12609-2:2013ISO 12609-2:2013(E)should be adequate to ensure the exposure limit is not exceeded (see Annex F). This excess factor is likely to be dif
41、ferent for a patient/client and operator; therefore, the FPF of protective eyewear for patient and operator would be different.4.3 Luminous transmittance and colour perception4.3.1 The luminous transmittance and the colour of the environment as seen through ILS protective filters (perceived colour)
42、are important characteristics of protective eyewear which enable the operator to perform treatment without compromising non-optical radiation safety (see Annex G and Annex H).4.3.2 Perceived colour depends on the spectral characteristics of the protective filter and illumination source. Thus, treatm
43、ent might be performed under general light conditions (white light) or operating procedures might require an operator to observe the patient/client and control the equipment illuminated with radiation from ILS equipment.In these two cases, the colour of the environment (for example, equipment contro
44、ls and blood) might appear different when seen through the same protective eyewear.4.3.3 Colour is described as a (x, y) Commission Internationale de LEclairage (CIE) colour coordinate and might be presented in a CIE chromaticity chart (see Annex H). The (x, y) CIE coordinates take into account spec
45、tral characteristics of the filter and illumination source.5 User comfort and secondary safety issues5.1 Peripheral leakageConsideration should be given to the good fit of safety eyewear to prevent penetration of optical radiation from around the frame. This should be tested using a bright light pri
46、or to each use.NOTE A patients aversion response might be altered due to anaesthesia, sedation, or other drugs.5.2 Secondary reflections from eyewear frame and filtersSecondary reflections from frames or filters of protective eyewear might increase the risk of uncontrolled exposure of the user or ot
47、hers; therefore, mirror-finish or high gloss filters and frames should not be used.5.3 Quality of filters and clarity of vision5.3.1 Quality of filters of protective eyewear and clarity of vision should not limit the intended use of the ILS equipment; therefore, these characteristics are essential f
48、or an operator and unimportant for a patient/client. Patient/client protective eyewear may be opaque.5.3.2 Filters of operators eyewear should be free from any material or surface defects which are likely to impair the intended use, such as bubbles, scratches, inclusions, dull spots, scoring, excess
49、ive colouration, or other defects.5.4 Exposure to bright flashes below ELVs5.4.1 For lower exposure levels (below ELVs), visual effects due to the temporary visual impairment might pose secondary safety hazards. Transient visual effects include disability (dazzle or veiling) glare, discomfort glare, startle (distraction), and after-images (flash blindness) (see Annex A).5.4.2 Exposure to bright flashes cannot be corrected by the passive attenuation filters because passive filters attenuate ambient and flash level simultaneously. To reduce t
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