BS-8497-1-2008.pdf

BS 8497-1:2008 Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications Part 1: Specification for products ICS 13.340.20 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW BRITISH STANDARD Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boeing Co/5910770001 Not for Resale, 08/14/2008 20:09:46 MDTNo reproduction or networking permitted without license from IHS -,-,- Publishing and copyright information The BSI copyright notice displayed in this document indicates when the document was last issued. © BSI 2008 ISBN 978 0 580 58403 9 The following BSI references relate to the work on this standard: Committee reference PH/2/3 Draft for comment 07/30162194 DC Publication history First published March 2008 Amendments issued since publication Amd. no.DateText affected BS 8497-1:2008 Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boeing Co/5910770001 Not for Resale, 08/14/2008 20:09:46 MDTNo reproduction or networking permitted without license from IHS -,-,- © BSI 2008i BS 8497-1:2008 Contents Foreword ii Introduction 1 1Scope 1 2Normative references 1 3Terms and definitions 1 4Spectral transmittance 2 5Luminous transmittance 2 6Colour of the protective filters 3 7Material and surface defects 3 8Active filters 4 9Construction of eye protectors 4 10Labelling 4 11Information to be supplied by the manufacturer 5 Annexes Annex A (informative) Filter protection factor (FPF) 6 Annex B (informative) Calculation of FPF for protective eyewear Example 1 7 Annex C (informative) Calculation of FPF for protective eyewear Example 2 9 Annex D (informative) Spectral hazard weighting functions 12 Bibliography 15 List of figures Figure B.1 Spectral irradiance of ILS device A with different filtering attachments 7 Figure B.2 Transmittance of eyewear protective filters 1, 2, 3 and 4 8 Figure C.1 Spectral irradiance of ILS device B with interchangeable lamps 1, 2 and 3 9 Figure C.2 Spectral transmittance of eyewear protective filters 5, 6 and 7 10 List of tables Table B.1 FPF of filters 1, 2 3 and 4 and different filtering attachments of ILS device A 9 Table C.1 FPF of filters 5, 6 and 7 and interchangeable lamps 1, 2 and 3 of ILS device B 11 Table D.1 Ultra-violet hazard weighting function S() 12 Table D.2 Blue light hazard B() and retinal thermal hazard R() weighting functions 13 Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, pages 1 to 15 and a back cover. Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boeing Co/5910770001 Not for Resale, 08/14/2008 20:09:46 MDTNo reproduction or networking permitted without license from IHS -,-,- BS 8497-1:2008 ii© BSI 2008 Foreword Publishing information This British Standard is published by BSI and came into effect on 31 March 2008. It was prepared by Technical Committee PH/2/3, Eye protection against lasers. A list of organizations represented on this committee can be obtained on request to its secretary. Information about this document This is a new standard, which has been written to fill a need for the standardization of protective eyewear for users of intense light source equipment. Presentational conventions The provisions of this standard are presented in roman (i.e. upright) type. Its requirements are expressed in sentences in which the principal auxiliary verb is “shall”. Commentary, explanation and general informative material is presented in smaller italic type, and does not constitute a normative element. Contractual and legal considerations This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard cannot confer immunity from legal obligations. Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boeing Co/5910770001 Not for Resale, 08/14/2008 20:09:46 MDTNo reproduction or networking permitted without license from IHS -,-,- © BSI 20081 BS 8497-1:2008 Introduction Protective eyewear for intense light source (ILS) equipment protects against excessive exposure to optical radiation during normal operation of the equipment and foreseeable accidental exposure due to equipment malfunctioning or human error. This includes accidental and cumulative exposure, and discomfort associated with viewing bright reflections. 1 Scope This British Standard specifies performance, test methods 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 180 nm to 3 000 nm, with the exception of laser radiation. This standard is not applicable to eye protectors for use with tanning equipment, ophthalmic instruments or other medical/cosmetic devices, the safety issues of which are addressed through other European and British standards. 2 Normative references The following normative documents contain provisions which, through reference in this text, constitute provisions of this British Standard. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. For undated references, the latest edition of the publication referred to applies. BS EN 167:2002, Personal eye-protection Optical test methods BS EN 168:2002, Personal eye-protection Non-optical test methods 3 Terms and definitions For the purpose of this British Standard, the following terms and definitions apply. 3.1blue light hazard potential for a photochemically induced retinal injury resulting from optical radiation exposure in the wavelength range 300 nm to 700 nm 3.2filter protection factor (FPF) factor by which the filter attenuates the weighted ocular exposure NOTEMathematical expressions for FPF are given in Annex A and example calculations in Annex B and Annex C. 3.3infra-red eye lens hazard potential for a thermal injury to cornea and lens of the eye resulting from optical radiation exposure in the wavelength range 780 nm to 3 000 nm 3.4intense light source (ILS) device incorporating one or more non-laser sources of optical radiation of the wavelength range 180 nm to 3 000 nm and intended for creating biological effects in humans and animals NOTEIt may operate in continuous or pulsed regime. Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boeing Co/5910770001 Not for Resale, 08/14/2008 20:09:46 MDTNo reproduction or networking permitted without license from IHS -,-,- BS 8497-1:2008 2© BSI 2008 3.5retinal thermal hazard potential for a thermal retinal injury resulting from optical radiation exposure in the wavelength range 380 nm to 1 400 nm 3.6ultra-violet hazard potential for skin and ocular acute and chronic adverse effects resulting from optical radiation exposure in the wavelength range 180 nm to 400 nm 4 Spectral transmittance The spectral transmittance t() of the eye protector material shall be determined for normal incidence. The wavelength shall be determined within ±2 nm. Filters with angular dependent transmittance shall be measured at angles of incidence between 0° and 45°. 5 Luminous transmittance 5.1 The luminous transmittance (tV) of the protective filters intended for use by the ILS operator shall be determined as: where E() is the spectral radiance flux of the illumination source; V() is spectral luminous efficiency; is the wavelength interval of the measurements, in nm; t() is the spectral transmittance of filter material at wavelength . 5.2 Luminous transmittance, as determined in 5.1, shall be stated for a D65 standard illuminator. NOTEThere 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. 780 380 V 780 380 ( ) ( ) ( ) ( ) ( ) VtE t VE = = = = = Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boeing Co/5910770001 Not for Resale, 08/14/2008 20:09:46 MDTNo reproduction or networking permitted without license from IHS -,-,- © BSI 20083 BS 8497-1:2008 6 Colour of the protective filters 6.1 The Commision Internationale de L'Eclairage (CIE) colour co-ordinates (x, y) of the protective filters intended for use by the ILS operator shall be determined as: and where and , and are CIE colour matching functions; E() is the spectral radiance flux of the illumination source; V() is spectral luminous efficiency; is the wavelength interval of the measurements, in nm; t() is the spectral transmittance of filter material at wavelength . 6.2 The colour co-ordinates (x, y) shall be specified for a D65 standard illuminator in accordance with 6.1. NOTE 1The colour co-ordinates (x, y) of the protective filters might be optionally presented on a CIE chromaticity chart. NOTE 2There 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. 7 Material and surface defects When tested in accordance with BS EN 167:2002, Clause 5, eye protectors intended for use by ILS equipment operators shall have a clear field of vision at least ±40° in the vertical and horizontal directions for each eye. NOTEThere are no requirements for the field of vision, material and surface defects of the filters of eye protectors intended for use by ILS equipment patients/clients; these filters may be opaque. X x XYZ = + Y y XYZ = + xyz 780 380 ( ) ( ) ( )XEtx= 780 380 ( ) ( ) ( )YEty= 780 380 ( ) ( ) ( )ZEtz= Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boeing Co/5910770001 Not for Resale, 08/14/2008 20:09:46 MDTNo reproduction or networking permitted without license from IHS -,-,- BS 8497-1:2008 4© BSI 2008 8 Active filters 8.1 In the case of protective filters that exhibit a change of transmittance in response to an exposure to incident optical radiation, the time taken by the eye protector to reach its full attenuation (“dark state”) shall be determined and specified. 8.2 Active filters powered by mains or batteries shall fail to a safe state if the power supply is disconnected or malfunctions. 8.3 Active filters shall be tested to determine the maximum time to achieve full specified attenuation, for the whole spectral range of emission of the intended ILS equipment and angles of incidence between 0° and 45°. 9 Construction of eye protectors 9.1 Mirror-finish or high gloss filters and frames shall not be used. NOTESecondary reflections from frames or filters of protective eyewear, especially from concave surfaces, might increase the risk of uncontrolled exposure of the users. 9.2 Frames and side shields shall either: be opaque; or provide at least the same protection as the filter; and be designed in such a way as to prevent the leakage of optical radiation around the edges of protective eyewear. 9.3 The removal of individual filters from the frame shall only be possible with the use of special tools. If the filters consist of several individual filters (hybrid filters), they shall be assembled in such a way that they cannot be interchanged. NOTEHybrid filters should not delaminate after storage, when tested in accordance with BS EN 168:2002, Clause 5. 9.4 The resistance of filters and frames to ignition shall conform to BS EN 168:2002, Clause 7. 9.5 When tested in accordance with BS EN 168:2002, Clause 5 and Clause 6, the transmittance increase shall be no more than 5%. 10 Labelling Each ILS eye protector shall be clearly and permanently marked to indicate: a)model number; b)whether it is intended for the ILS patient/client only; c)manufacturers identification. If the information is marked on the filters, they shall not impair vision or the protective effect. Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boeing Co/5910770001 Not for Resale, 08/14/2008 20:09:46 MDTNo reproduction or networking permitted without license from IHS -,-,- © BSI 20085 BS 8497-1:2008 11 Information to be supplied by the manufacturer Each ILS eye protector shall be supplied with printed user information in the language(s) of the country in which the eye protector is sold. This information shall include: a)a clear statement of the model number of the eye protection; b)a reproduction of the labelling in accordance with Clause 10 and an explanation of its meaning; c)spectral transmittance of the filters in tabular or graphic form at 2 nm intervals; d)for eye protectors intended for use by an ILS operator, luminous transmittance in accordance with Clause 5; e)for eye protectors intended for use by an ILS operator, the CIE colour co-ordinates (x, y) of the protective filters in accordance with Clause 6, with optional presentation on a CIE chromaticity chart; f)for active filters, maximum time to achieve specified attenuation, in accordance with Clause 8; g)for active filters powered by electrical mains or batteries, specification of power settings and power tolerances; h)instructions for use, care, storage, cleaning and disinfection of the eye protector; i)instructions for inspection and guidance on when the eye protector should be replaced; j)the name and address of the manufacturer or supplier of the eye protector; k)certification mark, if applicable. Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boeing Co/5910770001 Not for Resale, 08/14/2008 20:09:46 MDTNo reproduction or networking permitted without license from IHS -,-,- BS 8497-1:2008 6© BSI 2008 Annex A (informative)Annex A (informative) Filter protection factor (FPF) A.1 Neither optical density or shade numbers are suitable for characterization of ILS protective filters as these characteristics do not take into account the difference in the effect of different wavelengths on the eye, whereas exposure limit values (ELVs) (taken from the Physical Agents (Artificial Optical Radiation) Directive) refer to effective, e.g. spectrally weighted, radiance values. A.2 FPF is defined as: (A1) for blue light hazards; (A2) for retinal thermal hazards; (A3) for actinic ultra-violet h