EN ISO 12866-1999 en Ophthalmic Instruments - Perimeters (Incorporates Amendment A1 2008)《眼科仪器 视野镜 包含修改件A1-2008》.pdf

1、NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW +A1:2008National foreword This British Standard is the UK implementation of EN ISO 12866:1999+A1:2008. It is identical with ISO 12866:1999, in- corporating am

2、endment 1:2008. It supersedes BS EN ISO 12866:1999 which is withdrawn. The start and finish of text introduced or altered by amendment is in- dicated in the text by tags. Tags indicating changes to ISO text carry the number of the ISO amendment. For example, text altered by ISO amendment 1 is indica

3、ted by !“. The UK participation in its preparation was entrusted to Technical Committee CH/172, Ophthalmic optics, to Subcommittee CH/172/6, Ophthalmic instruments. A list of organizations represented on this subcommittee can be obtained on request to its secretary. This publication does not purport

4、 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. BS EN ISO 12866:1999+A1:2008 This British Standard, having been prepared under the direction of the Health and

5、Environment Sector Committee, was published under the authority of the Standards Committee and comes into effect on 15 September 1999 BSI 2009 ISBN 978 0 580 69251 2 Amendments/corrigenda issued since publication Date Comments 30 September 2009 Implementation of ISO amendment 1:2008 with CEN endorse

6、ment A1:2008:1999+A1 November 2008This document (EN ISO 12866:1999/A1:2008) has been prepared by Technical Committee ISO/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 Amendment to the Eu

7、ropean Standard EN ISO 12866:1999 shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by May 2009, and conflicting national standards shall be withdrawn at the latest by May 2009. Attention is drawn to the possibility that som

8、e 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. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to impl

9、ement this European Standard: 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

10、 and the United Kingdom. Endorsement notice The text of ISO 12866:1999/Amd.1:2008 has been approved by CEN as a EN ISO 12866:1999/A1:2008 without any modification. BS EN ISO 12866:1999+A1:2008 EN ISO 12866:1999 Foreword to amendment A1 BS EN ISO 12866:1999+A1:2008 EN ISO 12866:1999BS EN ISO 12866:19

11、99+A1:2008 EN ISO 12866:1999 7 7 7 7 7 7 7 7 8 9 11 8 Annex C (normative) Minimum requirements for a normative database .12 BS EN ISO 12866:1999+A1:2008 EN ISO 12866:1999BS EN ISO 12866:1999+A1:2008 EN ISO 12866:1999ISO 15004-1:2006, Ophthalmic instruments Fundamental requirements and test methods P

12、art 1: General requirements applicable to all ophthalmic instruments IEC 60601-1:2005, Medical electrical equipment Part 1: General requirements for basic safety and essential performance ! “ BS EN ISO 12866:1999+A1:2008 EN ISO 12866:1999BS EN ISO 12866:1999+A1:2008 EN ISO 12866:1999BS EN ISO 12866:

13、1999+A1:2008 EN ISO 12866:1999BS EN ISO 12866:1999+A1:2008 EN ISO 12866:1999BS EN ISO 12866:1999+A1:2008 EN ISO 12866:19994.4.3 For typical stimulus and background parameters the instrument shall be capable of comparing the result of each tested location with the age-specific normal value. NOTE Typi

14、cal parameters are those that are recommended by the manufacturer for routine use. 4.4.4 The version of the normal value table shall be specified by an ordinal version number and the date of issue of this table. Specification shall include the size and the age range of the normative database. The no

15、rmative database shall fulfill the minimum requirements given in Annex C. 4.4.5 Printouts shall contain the version number of the normal value table used. 4.4.6 When new normal value table versions are implemented into an instrument by software update or other means, the user shall be notified. ! “

16、BS EN ISO 12866:1999+A1:2008 EN ISO 12866:1999 6BS EN ISO 12866:1999+A1:2008 EN ISO 12866:1999 76 Accompanying documents The perimeter shall be accompanied by documents containing instructions for use. In addition to the requirements laid down in 4.2.3, 4.2.4, 4.2.5, 4.4.1, 4.4.2 and 4.4.4 this info

17、rmation shall contain: a) name and address of the manufacturer; b) if appropriate, a statement that the perimeter in its original packaging conforms to the transport conditions as specified in 5.3 of ISO 15004-1:2006; c) any additional documents as specified in 7.9 of IEC 60601-1:2005; d) specificat

18、ion of examination strategies. ! “ BS EN ISO 12866:1999+A1:2008 EN ISO 12866:1999 8BS EN ISO 12866:1999+A1:2008 EN ISO 12866:1999 9BS EN ISO 12866:1999+A1:2008 EN ISO 12866:1999 10BS EN ISO 12866:1999+A1:2008 EN ISO 12866:1999 11Annex C (normative) Minimum requirements for a normative database Norma

19、l values for perimeters shall be based on a study that fulfils the following criteria: a) Predefined criteria for healthy eyes that are included in the database, covering at least the following items: minimum visual acuity; maximum spherical and cylindrical correction; pathological conditions that l

20、ead to exclusion, independent of whether they are previously known or detected in the course of examination, and that are based on findings other than the visual field; b) predefined criteria for the minimum experience in perimetric testing; c) predefined method to choose the eye to be examined; onl

21、y one eye of each subject can be included; d) predefined criteria of unreliable examinations, which may cover the following items: fixation behaviour; false positive responses; false negative responses; e) no exclusion of examinations for reasons other than the predefined criteria; NOTE Exclusion of

22、 examinations based only on the results is not allowed. The exclusion of examinations based on pathological conditions that are found with the help of the result and that fulfil predefined criteria of exclusion is allowed. f) a minimum sample size of 60 eyes; g) a minimum of ten eyes of subjects you

23、nger than 30 years; h) a minimum of ten eyes of subjects older than 60 years. ! “ BS EN ISO 12866:1999+A1:2008 EN ISO 12866:1999 12BS EN ISO 12866:1999+A1:2008 EN ISO 12866:1999BSI Group Headquarters 389 Chiswick High Road, London, W4 4AL, UK Tel +44 (0)20 8996 9001 Fax +44 (0)20 8996 7001 standard

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