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1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 13503-3:2000 The Eu
2、ropean Standard EN 13503-3:2000 has the status of a British Standard ICS 11.040.70 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Ophthalmic implants Intraocular lenses Part 3: Mechanical properties and test methods Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:52
3、:18 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 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 October 2000 BSI 10-2000 ISBN 0 580 36035 0 BS EN 13
4、503-3:2000 Amendments issued since publication Amd. No.DateComments National foreword This British Standard is the official English language version of EN 13503-3:2000. It supersedes BS ISO 11979-3:1999 which is withdrawn. The UK participation in its preparation was entrusted by Technical Committee
5、CH/78, Ophthalmic optics, to Subcommittee CH/78/7, Eye implants, which has the responsibility to: aid enquirers to understand the text; present to the responsible European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related inte
6、rnational and European developments and promulgate them in the UK. 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 document may be f
7、ound in the BSI Standards Catalogue under the section entitled International Standards Correspondence Index, or by using the Find facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards
8、are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 38, an inside back cover and a back cover. The BSI
9、 copyright notice displayed in this document indicates when the document was last issued. Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:52:18 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 13503-3 June 2000 ICS 11.040.70 English version Op
10、hthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods (ISO 11979-3:1999, modified) Implants ophtalmiques - Lentilles intraoculaires - Partie 3: Proprits mcaniques et mthodes dessai (ISO 11979- 3:1999, modifi) Ophthalmische Implantate - Intraokularlinsen - Teil 3: Me
11、chanische Anforderungen und Prfverfahren (ISO 11979-3:1999, modifiziert) This European Standard was approved by CEN on 12 May 2000. 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 stan
12、dard without any alteration. Up-to-date lists and bibliographical references concerning such national standards 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 version in any other l
13、anguage made by translation under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greec
14、e, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Central Secretariat: rue de Stassart, 36 B-1050 Brussels 2000 CENAll rights of ex
15、ploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 13503-3:2000 E Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:52:18 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 2 EN 13503-3:2000 BSI 10-2000 Contents Foreword2 1Scope4 2Normative referenc
16、es4 3Terms and definitions5 4Requirements7 4.1General7 4.2Tolerances and dimensions7 4.3Compression force8 4.4Axial displacement in compression8 4.5Optic decentration8 4.6Optic tilt8 4.7Angle of contact8 4.8Compression force decay8 4.9Dynamic fatigue durability9 4.10Loop strength9 4.11Surface and bu
17、lk homogeneity9 5Supplementary information available from the manufacturer10 Annex A (normative)Measurement of compression force11 Annex B (normative)Measurement of axial displacement in compression14 Annex C (normative)Measurement of optic decentration16 Annex D (normative)Measurement of optic tilt
18、18 Annex E (normative)Measurement of angle of contact21 Annex F (normative)Measurement of compression force decay23 Annex G (normative)Testing of dynamic fatigue durability24 Annex H (informative)Measurement of loop pull strength26 Annex I (informative) Mechanical data analysis 27 Bibliography38 Lic
19、ensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:52:18 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 3 EN 13503-3:2000 BSI 10-2000 Foreword This European Standard has been prepared by Technical Committee CEN/TC 170, Ophthalmic optics, the secretariat of which is held by DIN. This European St
20、andard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by December 2000, and conflicting national standards shall be withdrawn at the latest by December 2000. European Standard EN 13503 was developed by CEN/TC 170, Ophthal
21、mic optics, in cooperation with ISO/TC 172/SC 7, Ophthalmic optics and instruments, and is published in several parts under the general title Ophthalmic implants - Intraocular lenses: Part 1: Vocabulary Part 2: Optical properties and test methods Part 3: Mechanical properties and test methods Part 4
22、: Labelling and information Part 5: Biocompatibility Part 6: Shelf-life and transport stability Part 7: Clinical investigations Part 8: Fundamental requirements EN 13503 is the modified ISO 11979. The main difference between both series of standards is that ISO 11979 is based on the reference to ISO
23、 14155 Clinical investigation of medical devices while EN 13503 is based on the reference to EN 540 Clinical investigation of medical devices for human subjects. Compared with ISO 11979-3 the present European Standard EN 13503-3 does not contain the informative annex detailing mechanical data analys
24、is (Annex I of ISO 11979-3). Modifications of ISO 11979-3 are indicated as follows: - text which has been deleted is striked out; - text which has been changed or added is underlined. Cross references to ISO 11979-3 are given where possible. This Part 3 of EN 13503 contains seven normative annexes,
25、A to G, and one informative annex, Annex H. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland,
26、 Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of the International Standard ISO 11979-3:1999 was approved by CEN as a European Standard with agreed common modifications as given in the Foreword and indicated in the t
27、ext by strike-out and underlining. Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:52:18 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 4 EN 13503-3:2000 BSI 10-2000 Introduction This part of ISO 11979 EN 13503 contains methods for which requirements are given and methods for which no req
28、uirements are formulated. The former are considered essential for the safety or performance of the intraocular lens, while the latter provide essential information to the ophthalmic surgeon or are used for other purposes. A special purpose is the use of mechanical data to assess the need for clinica
29、l investigation of modifications of existing models as described in ISO 11979-7 EN 13503-7 1. Because of the complexity of this analysis detailed descriptions and examples have been given in Annex I. Due to the wide variety of intraocular lens designs already on the market, it has not been possible
30、to devise test methods that are applicable to every design under all circumstances. It can be anticipated that new materials currently under development will result in drastically new designs that will require modified or other test methods. As with all standards, it is then up to the parties using
31、the standard to modify or develop corresponding methods and give rationale and validation for them in a spirit that is consistent with this International European Standard. In the cases where different tolerances have been given depending on material or design they reflect an already existing situat
32、ion with well established products. NOTE: It always was and still is the intention of the Technical Committees ISO/TC 172/SC 7 and CEN/TC 170 to prepare identical ISO and CEN (European Committee for Standardization) Standards on intraocular lenses. However, during the preparation of part 7 of this s
33、eries, problems were encountered with normative references to the existing ISO 14155 and EN 540 horizontal standards on clinical investigation of medical devices, which are similar but not identical. ISO and CEN principles concerning normative references made it impossible to continue the preparatio
34、n of identical European and International Standards on the clinical investigation of intraocular lenses. As a result, two different standards series have had to be prepared. It is the intention of CEN/TC 170 and ISO/TC 172/SC 7 to revise these standards with the goal to end up with identical ones as
35、 soon as identical ISO and CEN horizontal standards on clinical investigation become available. 1Scope This part of ISO 11979 EN 13503 specifies requirements and test methods for certain mechanical properties of intraocular lenses (IOLs). It is applicable to all types of IOLs intended for implantati
36、on in the anterior segment of the human eye, excluding corneal implants, provided that the test method is appropriate to the particular design. NOTE: For certain designs and certain applications, a specific test method described in this part of ISO 11979 EN 13503 may not be applicable. In such insta
37、nces the IOL manufacturer should devise corresponding test methods and provide validation and rationale for them. 2Normative references This European Standard incorporates by dated or undated references, provisions from other publications. These normative references are cited at the appropriate plac
38、es in the text and the publications are listed hereafter. For dated references, subsequent amendments to or revisions of any of these publications apply to this European Stan- dard only when incorporated in it by amendment or revision. For undated references the latest edition of the publication ref
39、erred to applies (including amendments). EN ISO 11979-1:1999, Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary. EN ISO 11979-2:1999, Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods. EN ISO 11979-4:2000, Ophthalmic implants - Intraocular lenses - Pa
40、rt 4: Labelling and information. Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:52:18 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 5 EN 13503-3:2000 BSI 10-2000 3Terms and definitions For the purposes of this part of ISO 11979 EN 13503, the terms and definitions given in EN ISO 11979-1
41、:1999 apply. For the convenience of the reader, some of these terms and definitions are reproduced here. 3.1 body central part of an intraocular lens incorporating the optic See Figure 1. 3.2 clear optic diameter of the circle, concentric with the optical axis of an intraocular lens, containing only
42、 features of the intraocular lens belonging to the optical design See Figure 1. 3.3 in situ in equilibrium with aqueous humour at 35 C See also EN ISO 11979-2:1999. 3.4 multipiece intraocular lens intraocular lens assembled from separate loop and body components NOTE: An intraocular lens with a body
43、 and two loops is often referred to as a three-piece intraocular lens. 3.5 one-piece intraocular lens intraocular lens in which the haptic is an integral part of the body 3.6 optic decentration lateral displacement of the optic due to compression of the haptic(s), measured as distance between the ge
44、ometric centre of the clear optic and the centre of a cylinder of a specified diameter to which the intraocular lens is confined See Figure C.1. 3.7 optic tilt angle between the optical axis of the intraocular lens in the uncompressed state and that in the compressed state, with the intraocular lens
45、 being confined to a specified diameter 3.8 overall diameter diameter of the cylinder circumscribing an intraocular lens, be it haptic or optic, with the axis of the cylinder coincident with the optical axis of the intraocular lens See Figure 1. Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29
46、 08:52:18 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 6 EN 13503-3:2000 BSI 10-2000 3.9 positioning hole hole, whether penetrating or not, intended to be used for clinical manipulation See Figure 1. 3.10 sagitta maximum distance between the planes, normal to the optical axis, which contact respe
47、ctively the most anterior and the most posterior points, be it haptic or optic, of an uncompressed intraocular lens See Figure 1. 3.11 vault height distance between the plane, normal to the optical axis, containing the vertex of the iris-proximal optical surface and the plane, normal to the optical
48、axis, containing the most iris-proximal point of the uncompressed haptic of an intraocular lens See Figure 1. NOTE 1: The iris-proximal side of the intraocular lens refers to the intended position as implanted. NOTE 2: The vault height is positive if the distance defined is in the direction towards
49、the retina as implanted, and negative if not. Key 1 Overall diameter 2 Positioning holes 3 Clear optic 4 Body 5 Vault height 6 Sagitta Figure 1 - Indicative illustration of some dimensional parameters of an intraocular lens Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:52:18 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 7 EN 13503-3:2000 BSI 10-2000 4Requirements 4.1General Properties of IOLs that do not change their dimensions after implantation shall be determined at 23 C 2 C and
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