EN ISO 10343-2014 en Ophthalmic instruments - Ophthalmometers《眼科仪器 检眼仪(ISO 10343 2014)》.pdf

1、BSI Standards PublicationBS EN ISO 10343:2014Incorporating corrigendum August 2014BS EN ISO 10343:2014Ophthalmic instruments Ophthalmometers (ISO10343:2014)ISBN 978 0 580 87607 3Amendments/corrigenda issued since publicationDate Text affected30 September 2014 Implementation of CEN Correction Notice

2、23 July 2014: Date of withdrawal in EN foreword correctedBS EN ISO 10343:2014 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO10343:2014. It supersedes BS EN ISO 10343:2009 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalC

3、ommittee CH/172/6, Ophthalmic instruments.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards I

4、nstitution 2014. Published by BSI StandardsLimited 2014ISBN 978 0 580 76708 1ICS 11.040.70Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 July 2014.Amendments i

5、ssued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 10343 July 2014 ICS 11.040.70 Supersedes EN ISO 10343:2009English Version Ophthalmic instruments - Ophthalmometers (ISO 10343:2014) Instruments ophtalmiques - Ophtalmomtres (ISO 10343:2014) Ophthalmisch

6、e Instrumente - Ophthalmometer (ISO 10343:2014) This European Standard was approved by CEN on 24 April 2014. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any altera

7、tion. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC 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

8、by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia

9、, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDAR

10、DIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2014 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 10343:2014 EBS EN ISO 10343:2014EN ISO

11、 10343:2014 (E) 3 Foreword This document (EN ISO 10343:2014) 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 DIN. This European Standard shall be given the status o

12、f a national standard, either by publication of an identical text or by endorsement, at the latest by January 2014, and conflicting national standards shall be withdrawn at the latest by January 2014. Attention is drawn to the possibility that some of the elements of this document may be the subject

13、 of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 10343:2009. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement thi

14、s European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovaki

15、a, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 10343:2014 has been approved by CEN as EN ISO 10343:2014 without any modification. EN ISO 10343:2014 (E) 3 Foreword This document (EN ISO 10343:2014) has been prepared by Technical Committee IS

16、O/TC 172 “Optics and photonics” 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 Ja

17、nuary 2015, and conflicting national standards shall be withdrawn at the latest by January 2015. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such pate

18、nt rights. This document supersedes EN ISO 10343:2009. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finl

19、and, Former Yugoslav Republic of Macedonia, France, Germany Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of IS

20、O 10343:2014 has been approved by CEN as EN ISO 10343:2014 without any modification. EN ISO 10343:2014 (E) 3 Foreword This document (EN ISO 10343:2014) has been prepared by Technical Committee ISO/TC 172 “Optics and photonics” in collaborat on with Technical Committee CEN/TC 170 “Ophthalmic optics”

21、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 January 2015, and conflicting national standards shall be withdra n at the latest by January 2015. Attentio

22、n is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 10343:2009. According to the CEN-CENELEC Internal Regulations,

23、 the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, La

24、tvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 10343:2014 has been approved by CEN as EN ISO 10343:2014 without any modification. BS EN ISO 10343:201

25、4ISO 10343:2014(E) ISO 2014 All rights reserved iiiContents PageForeword iv1 Scope . 12 Normative references 13 Terms and definitions . 14 Requirements 24.1 General . 24.2 Radius of curvature measurements 24.3 Measurement of direction of principal meridians 34.4 Eyepiece adjustment (if applicable) .

26、 35 Test methods . 35.1 General . 35.2 Checking optical requirements . 36 Accompanying documents 47 Marking, labelling and packaging 4Annex A (informative) Test devices and test configuration for checking meridional axesand ophthalmometer position . 5Bibliography 7BS EN ISO 10343:2014ISO 10343:2014(

27、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 member body interested in a subject for which a

28、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 all matter

29、s 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 of ISO documents should be noted. This docum

30、ent 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 responsible for identifying any or all such pate

31、nt 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 the convenience of users and does not constit

32、ute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT), see the following URL: Foreword - Supplementary informationThe comm

33、ittee responsible for this document is ISO/TC 172, Optics and photonics, Subcommittee SC 7, Ophthalmic optics and instruments.This third edition cancels and replaces the second edition (ISO 10343:2009), which has been technically revised.iv ISO 2014 All rights reservedBS EN ISO 10343:2014INTERNATION

34、AL STANDARD ISO 10343:2014(E)Ophthalmic instruments Ophthalmometers1 ScopeThis International Standard, together with ISO 15004-1, specifies requirements and test methods for continuously or digitally indicating ophthalmometers. Certain types of ophthalmometer have sufficient resolution and range (se

35、e Table 2) to adequately measure the radii of curvature of contact lenses complying with ISO 18369-3:2006, 4.1.3, and Clause 5. It is assumed that the local corneal front surface and both contact lens surfaces are spherical or toroidal.This International Standard takes priority over ISO 15004-1, if

36、differences exist.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (in

37、cluding any amendments) applies.ISO 8429, Optics and optical instruments Ophthalmology Graduated dial scaleISO 15004-1:2006, Ophthalmic instruments Fundamental requirements and test methods Part 1: General requirements applicable to all ophthalmic instrumentsIEC 60601-1, Medical electrical equipment

38、 Part 1: General requirements for basic safety and essential performance3 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.3.1ophthalmometerinstrument designed to measure and indicate the radii of curvature and principal meridians of the human corneas

39、 central area and of contact lenses3.2distance-dependent ophthalmometerophthalmometer in which the result of measurement is influenced by the distance between the instrument and the surface to be measured3.3toroidal surfacesurface having two orthogonal, circular “principal meridians”, one maximum an

40、d one minimum, and generated by a circular arc rotating about an axis which is in the same plane as the arc but which does not pass through its centre of curvature3.4principal curvature directiondirection in which the radius of curvature of the reflecting surface to be measured is at its minimum or

41、maximum ISO 2014 All rights reserved 1BS EN ISO 10343:2014ISO 10343:2014(E)3.5keratometric constantconversion value equal to 337,5 used to convert corneal curvature from inverse millimetres (mm1) to keratometric dioptresSOURCE: ISO 19980:2012, 3.113.6keratometric dioptresKDvalue of curvature, expres

42、sed in inverse millimetres (mm1), multiplied by the keratometric constant 337,5SOURCE: ISO 19980:2012, 3.124 Requirements4.1 GeneralThe ophthalmometer shall conform to the requirements specified in ISO 15004-1.4.2 Radius of curvature measurementsThe ophthalmometer shall conform to requirements given

43、 in Table 1 or Table 2. Conformity shall be verified as described in 5.2. If the instrument conforms to the requirement of Table 1 it is a “Type B” ophthalmometer. If the instrument conforms to the requirements of Table 2 it is a “Type A” ophthalmometer. Type A and Type B ophthalmometers have suffic

44、ient resolution and range to adequately measure human corneas. Type A ophthalmometers have sufficient resolution and range (see Table 2) to adequately measure the radii of curvature of contact lenses complying with ISO 18369-3:2006, 4.1.3, and Clause 5. It is assumed that the local corneal front sur

45、face and both contact lens surfaces are spherical or toroidal.Table 1 Requirements for measurement of radius of curvature and curvature for Type B ophthalmometers (applicable to human corneas only)Criterion RequirementMeasuring range 6,5 mm to 9,4 mm (52,0 KD to 36,0 KD)Indications given in terms of

46、 radii of curvaturecontinuously indicating instrumentsscale interval of 0,1 mm (0,25 KD)digitally indicating instru-mentsincrement 0,02 mm (0,125 KD)Measurement accuracy (twice the standard deviation, i.e. 2)0,05 mm2 ISO 2014 All rights reservedBS EN ISO 10343:2014ISO 10343:2014(E)Table 2 Requiremen

47、ts for measurement of radius of curvature and curvature for Type A ophthalmometers (applicable to contact lenses and human corneas)Criterion RequirementMeasuring range 6,5 mm to 9,4 mm (52,0 KD to 36,0 KD)Indications given in terms of radii of curvaturecontinuously indicating instrumentsscale interv

48、al of 0,02 mm (0,125 KD)digitally indicating instru-mentsincrement 0,02 mm (0,125 KD)Measurement accuracy (twice the standard deviation, i.e. 2)0,025 mm4.3 Measurement of direction of principal meridiansThe ophthalmometer shall conform to requirements given in Table 3. Conformity shall be verified a

49、s described in 5.2.Table 3 Requirements for measurement of direction of principal meridiansCriterion RequirementMeasuring range 0 to 180Meridian direction read-ingcontinuously indicating scales scale interval 5digitally indicating scales increment 1Measurement accuracy using test device (twice the standard deviation, i.e. 2)for principal meridional dif-ferences in radii of curva-ture 0,3 mm4for principal meridional dif-ferences in radii of curva-ture 0,3 mm2Angular indications shall be in accordance with ISO 8429.4.4 Eyepie