EN ISO 12865-2006 en Ophthalmic instruments - Retinoscopes《眼科仪器 视网膜检影镜 ISO 12865-2006》.pdf

1、BRITISH STANDARDBS EN ISO 12865:2006Ophthalmic instruments RetinoscopesThe European Standard EN ISO 12865:2006 has the status of a British StandardICS 11.040.70g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44

2、g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58BS EN ISO 12865:2006This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 August 2006 BSI 2006ISBN 0 580 48753 9National forewordThis British Standard is the official English language v

3、ersion of EN ISO 12865:2006. It is identical with ISO 12865:2006. It supersedes BS EN ISO 12865:1998 which is withdrawn.The UK participation in its preparation was entrusted by Technical Committee CH/172, Ophthalmic optics to Subcommittee CH/172/6, Ophthalmic instruments, which has the responsibilit

4、y to: A list of organizations represented on this subcommittee can be obtained on request to its secretary.Cross-referencesThe British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “Internati

5、onal Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online.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

6、 Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep UK interests informed; monitor related international and Europ

7、ean developments and promulgate them in the UK.Summary of pagesThis document comprises a front cover, an inside front cover, the EN ISO title page, the EN ISO foreword page, the ISO title page, pages ii and iii, a blank page, pages 1 to 3 and a back cover.The BSI copyright notice displayed in this d

8、ocument indicates when the document was last issued.Amendments issued since publicationAmd. No. Date CommentsEUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 12865July 2006ICS 11.040.70 Supersedes EN ISO 12865:1998 English VersionOphthalmic instruments - Retinoscopes (ISO 12865:2006)Instruments

9、 ophtalmiques - Rtinoscopes (ISO12865:2006)Ophthalmische Instrumente - Skiaskopes (ISO12865:2006)This European Standard was approved by CEN on 30 June 2006.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the st

10、atus of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the Central Secretariat or to any CEN member.This European Standard exists in three official versions (English, French, German). A v

11、ersion in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Eston

12、ia, 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.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHE

13、S KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Brussels 2006 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 12865:2006: EForeword This document (EN ISO 12865:2006) has been prepared by Technical Committee ISO/

14、TC 172 “Optics and optical 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 lat

15、est by January 2007, and conflicting national standards shall be withdrawn at the latest by January 2007. This document supersedes EN ISO 12865:1998. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this Europea

16、n Standard: Austria, Belgium, 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. Endorse

17、ment notice The text of ISO 12865:2006 has been approved by CEN as EN ISO 12865:2006 without any modifications. EN ISO 12865:2006Reference numberISO 12865:2006(E)INTERNATIONAL STANDARD ISO12865Second edition2006-07-01Ophthalmic instruments RetinoscopesInstruments ophtalmiques Skiascopes EN ISO 12865

18、:2006ii iiiForeword ISO (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 member body interested in a subject fo

19、r 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 Electrotechnical Commission (IEC) on

20、all matters of electrotechnical standardization. International Standards are drafted 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 ar

21、e circulated to the member bodies for voting. Publication as an International Standard 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 r

22、esponsible for identifying any or all such patent rights. ISO 12865 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 7, Ophthalmic optics and instruments. This second edition cancels and replaces the first edition (ISO 12865:1998), which has been technically revi

23、sed. EN ISO 12865:2006blank1Ophthalmic instruments Retinoscopes 1 Scope This International Standard, together with ISO 15004-1, specifies minimum requirements and test methods for hand-held streak and spot retinoscopes for use in objective determination of the refractive errors of the eye. This Inte

24、rnational Standard takes precedence over ISO 15004-1, if differences exist. 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 refere

25、nced document (including any amendments) applies. ISO 15004-1, Ophthalmic instruments Fundamental requirements and test methods Part 1: General requirements applicable to all ophthalmic instruments IEC 60601-1:2005, Medical electrical equipment Part 1: General requirements for basic safety and essen

26、tial performance 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 retinoscope ophthalmic instrument designed to assess objectively refractive errors of the eye by reflecting a beam of light into it from a mirror and observing the movement of t

27、he retinal reflex across the pupil NOTE A retinoscope usually consists of an illuminating system that produces a beam of light including a mirror with either a semi-reflective or a perforated highly-reflective coating, a viewing system and a power supply for the light source. 3.2 streak retinoscope

28、retinoscope capable of producing a beam of light of rectangular cross-section with adjustable focusing and orientation 3.3 spot retinoscope retinoscope capable of producing a beam of light of approximately circular cross-section NOTE The spot image focus can be adjustable. EN ISO 12865:20062 4 Requi

29、rements 4.1 General The retinoscope shall conform to the requirements specified in ISO 15004-1. The retinoscope shall conform to the specific requirements specified in 4.2 to 4.3. These requirements shall be verified as specified in Clause 5. 4.2 Optical and mechanical requirements The requirements

30、specified in Table 1 apply. Table 1 Requirements for optical and mechanical specifications Retinoscope Criterion Requirement Rotation W 190 Distance from the instrument to which the real imageaof the lamp filament is adjustable u 450 mm Distance from the instrument to which the virtual imageaof the

31、lamp filament is adjustable u 450 mm Length of streak imagebW 30 mm Width of streak imagebu 1,5 mm Deviation from linearity of the streak image at the focusbu 2 mm Streak retinoscope Rotational decentring of centre of streak imagebu 10 mm Distance of virtual imageaof lamp filament u 1 000 mm Spot re

32、tinoscope Spot diameter at 500 mm distanceau 25 mm aAll distances are measured from the light exit of the instrument. bWhen focused at 500 mm. 4.3 Construction and function 4.3.1 General a) When projecting the light beam onto a white surface and looking through the instrument, no internal reflection

33、 or scattered light shall be visible. b) The light beam luminous intensity shall be adjustable, continuously or in steps, from zero to its maximum. 4.3.2 Streak retinoscopes a) The streak image shall be continuously rotatable within the limits specified in Table 1. b) The streak imaging bundle of li

34、ght shall be continuously adjustable from convergent to divergent within the image distances specified in Table 1. c) The streak image shall be evenly illuminated and free from discoloration and distortion. NOTE An index stop at the infinite focus is optional. EN ISO 12865:200634.3.3 Spot retinoscop

35、es a) The spot image shall be circular, evenly illuminated and free from discolouration. b) If focusable, the imaging bundle shall be continuously adjustable from convergent to divergent within the image distances specified in Table 1 for streak retinoscopes. 5 Test methods 5.1 All tests described i

36、n this International Standard are type tests. 5.2 The requirements specified in 4.2 shall be verified by use of measuring devices with accuracy better than 10 % of the smallest value to be determined. 5.2.1 Concerning virtual image distance, check compliance with Table 1 by placing a) a +3,00 D lens

37、 at the light exit of a streak retinoscope; or b) a +2,00 D lens at the light exit of a spot retinoscope, and determine whether it is possible to produce a sharp image of the streak or spot, respectively, at a distance of 1 000 mm or less from the retinoscope. 5.2.2 The requirements specified in 4.3

38、.1 to 4.3.3 shall be checked by observation. 6 Accompanying documents The retinoscope shall be accompanied by documents containing instructions for use. In particular this information shall contain: a) name and address of the manufacturer; b) if appropriate, a statement that the retinoscope in its o

39、riginal packaging conforms to the transport conditions as specified in ISO 15004-1; c) any additional documents as specified in 7.9 of IEC 60601-1:2005; d) a reference to this International Standard (ISO 12865:2006), if the manufacturer or supplier claims compliance with it. 7 Marking The retinoscop

40、e shall be permanently marked with at least the following information: a) name of manufacturer or supplier; b) name and model of retinoscope; c) marking as required by IEC 60601-1. EN ISO 12865:2006BS EN ISO 12865:2006BSI389 Chiswick High RoadLondonW4 4ALBSI British Standards InstitutionBSI is the i

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