BS EN ISO 15004-2-2007 Ophthalmic instruments - Fundamental requirements and test methods - Light hazard protection《眼科仪器 基本要求和试验方法 光危害防护》.pdf

1、 g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58requirements and test methods Part 2: Light hazard protectionThe European Standard EN ISO 15004-2:2

2、007 has the status of a British StandardICS 11.040.70Ophthalmic instruments Fundamental BRITISH STANDARDBS EN ISO 15004-2:2007BS EN ISO 15004-2:2007This British Standard was published under the authority of the Standards Policy and Strategy Committee on 29 June 2007 BSI 2007ISBN 978 0 580 53959 6Ame

3、ndments issued since publicationAmd. No. Date Commentsrequest to its secretary.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.N

4、ational forewordThis British Standard was published by BSI. It is the UK implementation of EN ISO 15004-2:2007. Together with BS EN 15004-1:2006 it supersedes BS EN ISO 15004:1998 which is withdrawn.The UK participation in its preparation was entrusted by Technical Committee CH/172, Ophthalmic optic

5、s, to Subcommittee CH/172/6, Ophthalmic instruments.A list of organizations represented on this committee can be obtained on EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 15004-2February 2007ICS 11.040.70 Supersedes EN ISO 15004:1997 English VersionOphthalmic instruments - Fundamental requir

6、ements and testmethods - Part 2: Light hazard protection (ISO 15004-2:2007)Instruments ophtalmiques - Exigences fondamentales etmthodes dessai - Partie 2: Protection contre les dangersde la lumire (ISO 15004-2:2007)Ophthalmische Instrumente - Grundlegende Anforderungenund Prfverfahren - Teil 2: Schu

7、tz gegen Gefhrdung durchLicht (ISO 15004-2:2007)This European Standard was approved by CEN on 10 February 2007.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alter

8、ation. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the CEN 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 transl

9、ationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, Germany, Gr

10、eece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement

11、Centre: rue de Stassart, 36 B-1050 Brussels 2007 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 15004-2:2007: EForeword This document (EN ISO 15004-2:2007) has been prepared by Technical Committee ISO/TC 172 “Optics and optical

12、instruments“ in collaboration with Technical Committee CEN/TC 170 “Ophthalmic optics“, 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 August 2007, and con

13、flicting national standards shall be withdrawn at the latest by August 2007. This document supersedes EN ISO 15004:1997. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium,

14、 Bulgaria, 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 and United Kingdom. Endorsement notice The tex

15、t of ISO 15004-2:2007 has been approved by CEN as EN ISO 15004-2:2007 without any modifications. EN ISO 15004-2:2007Reference numberISO 15004-2:2007(E)INTERNATIONAL STANDARD ISO15004-2First edition2007-02-15Ophthalmic instruments Fundamental requirements and test methods Part 2: Light hazard protect

16、ion Instruments ophtalmiques Exigences fondamentales et mthodes dessai Partie 2: Protection contre les dangers de la lumire EN ISO 15004-2:2007ii iiiContents Page Foreword iv 1 Scope . 1 2 Normative references . 1 3 Terms, definitions and symbols 1 3.1 Terms and definitions. 1 3.2 Symbols . 5 4 Clas

17、sification. 6 5 Requirements 6 5.1 General. 6 5.2 Requirements for classification as a Group 1 instrument 6 5.3 Requirements for Group 2 instruments 7 5.4 Emission limits for determination of Group 1 classification . 7 5.5 Emission limits and guideline values for Group 2 instruments 11 6 Test method

18、s. 16 6.1 General. 16 6.2 Measurements made to classify instruments into Group 1 or Group 2 16 6.3 Group 2 instruments: Measurements.16 6.4 Determination of area. 17 6.5 Group 2 instruments: Determination of time and number of pulses to reach maximum exposure guidelines . 17 7 Information supplied b

19、y the manufacturer 18 Annex A (normative) Spectral weighting functions 20 Annex B (informative) Product-related International Standards for ophthalmic instruments to which ISO 15004-2 applies and which contain a specific light hazard section 26 Annex C (informative) Measurement instruments 27 Annex

20、D (normative) Measurement methods for radiance/irradiance 28 Annex E (informative) Guidance on the direct measurement of irradiance . 33 Annex F (informative) Classification flowchart . 35 Bibliography . 37 EN ISO 15004-2:2007iv Foreword ISO (the International Organization for Standardization) is a

21、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

22、 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 draft

23、ed 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 Stan

24、dard 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 15004-2 was prepared

25、 by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 7, Ophthalmic optics and instruments. This first edition, together with ISO 15004-1, cancels and replaces ISO 15004:1997. All reference to light hazard (definitions 3.4 to 3.9, subclause 6.3, subclause 7.5, Annexes A, C and D

26、of ISO 15004:1997) has essentially been moved to the present part of ISO 15004 and has been technically revised. ISO 15004 consists of the following parts, under the general title Ophthalmic instruments Fundamental requirements and test methods: Part 1: General requirements applicable to all ophthal

27、mic instruments Part 2: Light hazard protection EN ISO 15004-2:20071Ophthalmic instruments Fundamental requirements and test methods Part 2: Light hazard protection 1 Scope This part of ISO 15004 specifies fundamental requirements for optical radiation safety for ophthalmic instruments and is applic

28、able to all ophthalmic instruments that direct optical radiation into or at the eye and for which there is a specific light hazards requirement section within their respective International Standards, i.e. all ophthalmic instruments listed in Annex B. It is also applicable to all new and emerging op

29、hthalmic instruments that direct optical radiation into or at the eye. Where differences exist between this part of ISO 15004 and the light hazard requirements section of the respective vertical International Standard, then the vertical International Standard shall take precedence. NOTE The emission

30、 limits are based on the International Commission on Non-Ionizing Radiation Protection (ICNIRP) guidelines for human exposure to optical radiation. See Bibliography 1. This part of ISO 15004 does not apply to radiation that is in excess of limits specified in ISO 15004 and that is intended for treat

31、ment of the eye. This part of ISO 15004 classifies ophthalmic instruments into either Group 1 or Group 2 in order to distinguish instruments that are non-hazardous from those that are potentially hazardous. 2 Normative references The following referenced documents are indispensable for the applicati

32、on 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. IEC 60825-1:2001, Safety of laser products Part 1: Equipment classification, requirements and users guide 3 Terms, defi

33、nitions and symbols 3.1 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1.1 aperture aperture stop opening that defines the area over which average optical emission is measured NOTE For spectral irradiance measurements this opening is usually the

34、 entrance of a small sphere placed in front of the radiometer/spectroradiometer entrance slit. EN ISO 15004-2:20072 3.1.2 continuous wave radiation source CW radiation source radiation source that is operated with a continuous output for a time greater than 0,25 s (i.e. a non-pulsed radiation source

35、) 3.1.3 effective aperture portion of the aperture that limits the amount of light delivered to the retina NOTE For an obscured or noncircular aperture, it has an area equivalent to that of a non-obscured circular aperture. 3.1.4 emission limit maximum value of optical radiation output allowed 3.1.5

36、 endoilluminator device consisting of a light source and an associated fibre optic light guide that is intended for insertion into the eye to illuminate any portion of the interior of the eye 3.1.6 field of view conical solid angle as “seen” by the detector, such as the eye or the radiometer/spectro

37、radiometer, out of which the detector receives radiation NOTE The field of view denotes the angle over which radiance is averaged (sampled) and should not be confused with the angular subtense of the source which denotes source size. 3.1.7 Group 1 instrument ophthalmic instrument for which no potent

38、ial light hazard exists and that can be shown to fulfil the requirements of 5.2 3.1.8 Group 2 instrument ophthalmic instrument for which a potential light hazard exists and that does not fulfil the requirements of 5.2 3.1.9 irradiance E at a point on a surface quotient of the radiant power d inciden

39、t on an element of a surface containing the point, by the area dA of that element, i.e. ddEA= (1) NOTE Irradiance is expressed in units of watts per square centimetre, W/cm2. 3.1.10 manufacturer natural or legal person who places the ophthalmic instrument on the market 3.1.11 maximum intensity highe

40、st optical radiation emissions the instrument is capable of delivering under any and all conditions EN ISO 15004-2:200733.1.12 operation microscope stereo-microscope used for observation of surgical and other medical procedures, consisting of an illumination system and an observation system, includi

41、ng objective lens, variable or fixed power optical system, observation tube and eyepieces 3.1.13 optical radiation hazard risk of damage to the eye by exposure to optical radiant energy 3.1.14 photoretinitis retinal photochemically-induced injury resulting from a very intense retinal radiant exposur

42、e NOTE The term photic maculopathy is also used to describe photoretinitis in the fovea-macular area of the retina. 3.1.15 pulsed light source light source that delivers its energy in the form of a single pulse or a train of pulses where each pulse has a duration of less than 0,25 s NOTE 1 A light s

43、ource with a continuous train of pulses or modulated radiant energy where the peak radiated power is at least ten times the minimum radiated power is considered to be a pulsed light source. NOTE 2 The pulse duration is the interval of time between the first and last instants at which the instantaneo

44、us value of a pulse reaches a specified fraction of its pulse magnitude or a specified threshold. 3.1.16 radiance L in a given direction at a given point of a real or imaginary surface quantity defined by the formula ddcosdLA =(2) where d is the radiant power transmitted by an elementary beam passin

45、g through the given point and propagating in the solid angle d containing the given direction; dA is the area of a section of that beam containing the given point; is the angle between the normal to that section and the direction of the beam. NOTE 1 The same definition holds for the time-integrated

46、radiance Liif, in the equation for L, the radiant power d is replaced by the radiant energy dQ. NOTE 2 Radiance is expressed in watts per steradian square centimetre, W/(srcm2); time-integrated radiance is expressed in Joules per steradian square centimetre, J/(srcm2). 3.1.17 radiant exposure H at a

47、 point of a surface, for a given duration quotient of the radiant energy, dQ, incident on an element of a surface containing the point over the given duration by unit area dA of that element ddQHA= (3) EN ISO 15004-2:20074 Equivalently, the radiant exposure is defined as the integral of the irradian

48、ce, E, at a given point over a given duration, t dtH Et=(4) NOTE Radiant exposure is expressed in Joules per square centimetre, J/cm2. 3.1.18 scanning laser radiation laser radiation having a time-varying direction, origin or pattern of propagation with respect to a stationary frame of reference 3.1

49、.19 spectral irradiance Equotient of the spectral radiant power d () in a wavelength interval d, incident on an element of a surface, by the area dA of that element and by the wavelength interval d ( )dddEA=(5) NOTE Spectral irradiance is expressed in watts per square centimetre nanometre, W/(cm2.nm). 3.1.20 spectral radiance Lfor a wavelength interval d, in a given direction at a given point ratio of the spectral radiant power d () passing through that point and propa