DIN EN ISO 15004-2-2007 Ophthalmic instruments - Fundamental requirements and test methods - Part 2 Light hazard protection (ISO 15004-2 2007) English version of DIN EN ISO 15004-2.pdf

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1、June 2007DEUTSCHE NORM English price group 18No part of this standard may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11.040.70!,y“9862956www.d

2、in.deDDIN EN ISO 15004-2Ophthalmic instruments Fundamental requirements and test methods Part 2: Light hazard protection (ISO 15004-2:2007)English version of DIN EN ISO 15004-2:2007-06Ophthalmische Instrumente Grundlegende Anforderungen und Prfverfahren Teil 2: Schutz gegen Gefhrdung durch Licht (IS

3、O 15004-2:2007)Englische Fassung DIN EN ISO 15004-2:2007-06Together with DIN EN ISO15004-1:2006-09,supersedesDIN EN ISO 15004:1998-04www.beuth.deDocument comprises 44 pages 09.07DIN EN ISO 15004-2:2007-06 2 Start of validity This standard is valid from 1 June 2007. National foreword This standard in

4、cludes safety requirements. This standard has been prepared by Technical Committee ISO/TC 172 “Optics and photonics”, Subcommittee SC 7 “Ophthalmic optics and instruments” (Secretariat: DIN, Germany), in collaboration with Technical Committee CEN/TC 170 “Ophthalmic optics”. The responsible German bo

5、dy involved in its preparation was the Normenausschuss Feinmechanik und Optik (Optics and Precision Mechanics Standards Committee). The DIN Standard corresponding to the International Standard referred to in clause 2 of the EN is as follows: IEC 60825-1 DIN EN 60825-1 Amendments This standard differ

6、s from DIN EN ISO 15004:1998-04 as follows: a) All reference to light hazard (definitions 3.4 to 3.9, subclauses 6.3 and 7.5, and Annexes A, C and D) has been moved to DIN EN ISO 15004-2 and has been technically revised. b) All other specifications previously contained in DIN EN ISO 15004 have been

7、included in DIN EN ISO 15004-1. The requirements and tests for ignitability and the environmental requirements and tests have been amended. c) The revised EN ISO Standard has been adopted. Previous editions DIN EN ISO 15004: 1998-04 DIN EN ISO 15004-2:2007-06 3 National Annex NA (informative) Biblio

8、graphy DIN EN 60825-1, Safety of laser products Part 1: Equipment classification, requirements and users guide E DIN EN 62471, Photobiological safety of lamps and lamp systems DIN EN ISO 8612, Ophthalmic instruments Tonometers DIN EN ISO 9801, Ophthalmic instruments Trial case lenses DIN EN ISO 1034

9、1, Ophthalmic instruments Refractor heads DIN EN ISO 10342, Ophthalmic instruments Eye refractometers DIN EN ISO 10343, Ophthalmic instruments Ophthalmometers DIN EN ISO 10938, Ophthalmic instruments Chart projectors DIN EN ISO 10939, Ophthalmic instruments Slit-lamp microscopes DIN EN ISO 10940, Op

10、hthalmic instruments Fundus cameras DIN EN ISO 10942, Ophthalmic instruments Direct ophthalmoscopes DIN EN ISO 10943, Ophthalmic instruments Indirect ophthalmoscopes DIN EN ISO 10944, Ophthalmic instruments Synoptophores DIN EN ISO 12865, Ophthalmic instruments Retinoscopes DIN EN ISO 12866, Ophthal

11、mic instruments Perimeters DIN EN ISO 12867, Ophthalmic instruments Trial frames DIN EN ISO 15004-1, Ophthalmic instruments Fundamental requirements and test methods Part 1: General requirements applicable to all ophthalmic instruments DIN EN ISO 15253, Ophthalmic optics and instruments Optical devi

12、ces for enhancing low-vision DIN EN ISO 15254, Ophthalmic optics and instruments Electro-optical devices for enhancing low vision DIN EN ISO 19980, Ophthalmic instruments Corneal topographers DIN EN ISO 15004-2:2007-06 4 This page is intentionally blank EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NOR

13、MEN ISO 15004-2February 2007ICS 11.040.70 Supersedes EN ISO 15004:1997 English VersionOphthalmic instruments - Fundamental requirements and testmethods - Part 2: Light hazard protection (ISO 15004-2:2007)Instruments ophtalmiques - Exigences fondamentales etmthodes dessai - Partie 2: Protection contr

14、e les dangersde la lumire (ISO 15004-2:2007)Ophthalmische Instrumente - Grundlegende Anforderungenund Prfverfahren - Teil 2: Schutz 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 Interna

15、l Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. 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.T

16、his European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder 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 t

17、he national standards bodies of Austria, Belgium, 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

18、 and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement 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 150

19、04-2:2007: EContents Page 1 Scope . 2 Normative references . 3 Terms, definitions and symbols 3.1 Terms and definitions. 3.2 Symbols . 4 Classification. 5 Requirements 5.1 General. 5.2 Requirements for classification as a Group 1 instrument 5.3 5.4 5.5 Emission limits and guideline values for Group

20、2 instruments 6 Test methods.6.1 General.6.2 Measurements made to classify instruments into Group 1 or Group 2 6.3 6.4 Determination of area.6.5 Group 2 instruments: Determination of time and number of pulses to reach maximum exposure guidelines .7 Information supplied by the manufacturer Annex A (n

21、ormative) Spectral weighting functionsAnnex B (informative) Product-related International Standards for ophthalmic instruments to which ISO 15004-2 applies and which contain a specific light hazard sectionAnnex C (informative) Measurement instruments Annex D (normative) Measurement methods for radia

22、nce/irradiance Annex E (informative) Guidance on the direct measurement of irradiance .Bibliography . 2 EN ISO 15004-2:2007 (E) 89999101014 191919 19 20 . 34444ForewordRequirements for Group 2 instrumentsEmission limits for determination of Group 1 classification .Group 2 instruments: Measurements.

23、20 212329 3031 3638 40Annex F (informative) Classification flowchart . Foreword This document (EN ISO 15004-2:2007) has been prepared by Technical Committee ISO/TC 172 “Optics and photonics” in collaboration with Technical Committee CEN/TC 170 “Ophthalmic optics”, the secretariat of which is held by

24、 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 conflicting national standards shall be withdrawn at the latest by August 2007. This document supersedes EN ISO 15004:1997. A

25、ccording to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, L

26、atvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Endorsement notice The text of ISO 15004-2:2007 has been approved by CEN as EN ISO 15004-2:2007 without any modifications. 3 EN ISO 15004-2:2007 (E)

27、 1 Scope This part of ISO 15004 specifies fundamental requirements for optical radiation safety for ophthalmic instruments and is applicable 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

28、 respective International Standards, i.e. all ophthalmic instruments listed in Annex B. It is also applicable to all new and emerging ophthalmic instruments that direct optical radiation into or at the eye. Where differences exist between this part of ISO 15004 and the light hazard requirements sect

29、ion of the respective vertical International Standard, then the vertical International Standard shall take precedence. NOTE The emission limits are based on the International Commission on Non-Ionizing Radiation Protection (ICNIRP) guidelines for human exposure to optical radiation. See Bibliography

30、 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 treatment 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

31、from those that are potentially hazardous. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amen

32、dments) applies. IEC 60825-1:2001, Safety of laser products Part 1: Equipment classification, requirements and users guide 3 Terms, definitions 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 tha

33、t defines the area over which average optical emission is measured NOTE For spectral irradiance measurements this opening is usually the entrance of a small sphere placed in front of the radiometer/spectroradiometer entrance slit. 4 EN ISO 15004-2:2007 (E) 3.1.2 continuous wave radiation source CW r

34、adiation 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) 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

35、 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 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 po

36、rtion 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/spectroradiometer, 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 c

37、onfused with the angular subtense of the source which denotes source size. 3.1.7 Group 1 instrument ophthalmic instrument for which no potential 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 haza

38、rd 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 incident 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 cen

39、timetre, W/cm2. 3.1.10 manufacturer natural or legal person who places the ophthalmic instrument on the market 3.1.11 maximum intensity highest optical radiation emissions the instrument is capable of delivering under any and all conditions 5 EN ISO 15004-2:2007 (E) 3.1.12 operation microscope stere

40、o-microscope used for observation of surgical and other medical procedures, consisting of an illumination system and an observation system, including 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 ex

41、posure to optical radiant energy 3.1.14 photoretinitis retinal photochemically-induced injury resulting from a very intense retinal radiant exposure 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 sour

42、ce 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 source 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 con

43、sidered 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 instantaneous 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

44、 of a real or imaginary surface quantity defined by the formula ddcosdLA =(2) where d is the radiant power transmitted by an elementary beam passing 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 gi

45、ven 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 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 squar

46、e centimetre, W/(srcm2); time-integrated radiance is expressed in Joules per steradian square centimetre, J/(srcm2). 3.1.17 radiant exposure H at a 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 dur

47、ation by unit area dA of that element ddQHA= (3) 6 EN ISO 15004-2:2007 (E) Equivalently, the radiant exposure is defined as the integral of the irradiance, 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 scanni

48、ng laser radiation laser radiation having a time-varying direction, origin or pattern of propagation with respect to a stationary frame of reference 3.1.19 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

49、 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 propagating within the solid angle d in the given direction, to the product of the wavelength interval d and the areas of a section of that beam on a plane pe