BS-EN-ISO-11979-2-2000.pdf
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1、BRITISH STANDARD BS EN ISO 11979-2:2000 Incorporating Corrigendum No. 1 Ophthalmic implants Intraocular lenses Part 2: Optical properties and test methods The European Standard EN ISO 11979-2:1999 has the status of a British Standard ICS 11.040.70 ? Licensed Copy: sheffieldun sheffieldun, na, Sat No
2、v 18 01:34:04 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 11979-2:2000 This British Standard, having been prepared under the direction of the Health and Environment Sector Committee, was published under the authority of the Standards Committee and comes into effect on 15 May 2000 BSI 2006 I
3、SBN 0 580 35981 6 National foreword This British Standard is the official English language version of EN ISO 11979-2:1999, including Technical Corrigendum November 2003. It is identical with ISO 11979-2:1999. The UK participation in its preparation was entrusted by Technical Committee CH/8, Ophthalm
4、ic optics, to Subcommittee CH/78/7, Eye implants, which has the responsibility to: A list of organizations represented on this subcommittee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this d
5、ocument may be found in the BSI Catalogue under the section entitled “International 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 contra
6、ct. Users are responsible for its correct application. Compliance with a British 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
7、 change, and keep UK interests informed; monitor related international and European developments and promulgate them in the UK. Summary of pages This 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 to v, a blank p
8、age, pages 1 to 20, the annex ZA page, the annex ZB page, and inside back cover and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. DateComments 16077 Corrigendum No. 1 31 July 2006Changes to
9、subclause 4.4 Licensed Copy: sheffieldun sheffieldun, na, Sat Nov 18 01:34:04 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Incorporating Corrigendum November 2003 Licensed Copy: sheffieldun sheffieldun, na, Sat Nov 18 01:34:04 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 11979-2:1999 Licensed Cop
10、y: sheffieldun sheffieldun, na, Sat Nov 18 01:34:04 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Reference number ISO 11979-2:1999(E) INTERNATIONAL STANDARD ISO 11979-2 First edition 1999-12-15 Ophthalmic implants Intraocular lenses Part 2: Optical properties and test methods Implants ophtalmiques Len
11、tilles intraoculaires Partie 2: Proprits optiques et mthodes dessai EN ISO 11979-2:1999 Licensed Copy: sheffieldun sheffieldun, na, Sat Nov 18 01:34:04 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii EN ISO 11979-2:1999 Licensed Copy: sheffieldun sheffieldun, na, Sat Nov 18 01:34:04 GMT+00:00 2006, Un
12、controlled Copy, (c) BSI iii Contents Page Foreword.iv Introduction.v 1 Scope 1 2 Normative references1 3 Terms and definitions .1 4 Requirements.2 4.1 General2 4.2 Dioptric power2 4.3 Imaging quality.2 4.4 Spectral transmittance3 Annex A (normative) Measurement of dioptric power 4 Annex B (normativ
13、e) Measurement of resolution efficiency10 Annex C (normative) Measurement of MTF12 Annex D (informative) Precision of dioptric power determination.16 Annex E (informative) Precision of imaging quality determination.17 Annex F (informative) Verification of ray trace calculations.18 Annex G (informati
14、ve) Selected definitions19 Bibliography20 EN ISO 11979-2:1999 Licensed Copy: sheffieldun sheffieldun, na, Sat Nov 18 01:34:04 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iv Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO me
15、mber 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 on that committee. International organizations, governme
16、ntal 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 drafted in accordance with the rules given in the ISO/IEC Dire
17、ctives, Part 3. Draft International Standards adopted by the technical committees are 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 el
18、ements of this part of ISO 11979 may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. International Standard ISO 11979-2 was prepared by Technical Committee ISO/TC 172,Optics and optical instruments, Subcommittee SC 7,Ophthalmic optics
19、 and instruments. ISO 11979 consists of the following parts, under the general titleOphthalmic implants Intraocular lenses: ?Part 1: Vocabulary ?Part 2: Optical properties and test methods ?Part 3: Mechanical properties and test methods ?Part 4: Labelling and information ?Part 5: Biocompatibility ?P
20、art 6: Shelf-life and transport stability ?Part 7: Clinical investigations ?Part 8: Fundamental requirements Annexes A, B and C form a normative part of this part of ISO 11979. Annexes D, E, F and G are for information only. EN ISO 11979-2:1999 Licensed Copy: sheffieldun sheffieldun, na, Sat Nov 18
21、01:34:04 GMT+00:00 2006, Uncontrolled Copy, (c) BSI v Introduction This part of ISO 11979 contains several test methods for which associated requirements are given and one test method for which no requirement is formulated. The former are directly connected to the optical functions of intraocular le
22、nses. The latter, the test for spectral transmittance, has been provided for those interested in information about UV transmission and in specific situations, e.g. when using laser light sources for medical diagnosis and treatment. Extensive interlaboratory testing has been carried out before settin
23、g the limits specified. Some basic problems were encountered. The accuracy in the determination of dioptric power has an error that is not negligible in relation to the half-dioptre steps in which intraocular lenses are commonly labelled. The dioptric power tolerances take this fact into account. He
24、nce the limits set may lead to some overlap into the next labelled power, especially for high dioptre lenses. Reference 1 gives further discussion on this subject. The majority of lenses hitherto implanted have been made from poly(methyl methacrylate) (PMMA), and were qualified using the method desc
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