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1、BRITISH STANDARD BS EN 13503-5:2001 Ophthalmic implants Intraocular lenses Part 5: Biocompatibility The European Standard EN 13503-5:2001 has the status of a British Standard ICS 11.040.40; 11.040.70 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Licensed Copy: sheffieldun sh
2、effieldun, na, Sun Oct 29 08:52:18 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 13503-5:2001 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 Ma
3、y 2001 BSI 05-2001 ISBN 0 580 37275 8 National foreword This British Standard is the official English language version of EN 13503-5:2001. The UK participation in its preparation was entrusted by Technical Committee CH/78, Ophthalmic optics, to Subcommittee CH/78/7, Eye implants, which has the respo
4、nsibility 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 document may be found in the BSI Standards Catalogue under the section
5、 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 are responsible for their correct application. Co
6、mpliance with a British Standard does not of itself confer immunity from legal obligations. 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 internatio
7、nal and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 20, an inside back cover and a back cover. The BSI copyright date displayed in this document indicates when the document was last
8、issued. Amendments issued since publication Amd. No. DateComments 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 13503-5 March 2001 ICS 11.040.70; 11.100 English version Ophthalmic implan
9、ts - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:1999, modified) Implants ophtalmiques - Lentilles intraoculaires - Partie 5: Biocompatibilit (ISO 11979-5:1999, modifi) Ophthalmische Implantate - Intraokularlinsen - Teil 5: Biokompatibilitt (ISO 11979-5:1999, modifiziert) This Europea
10、n Standard was approved by CEN on 4 February 2001. 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 alteration. Up-to-date lists and bibliographical references conc
11、erning such national standards may be obtained on application to the 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 by translation under the responsibility of a CEN member into its own l
12、anguage and notified to the Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden,
13、 Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2001 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Re
14、f. No. EN 13503-5:2001 E Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:52:18 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 2 EN 13503-5:2001 Contents 1Scope 5 2Normative references 5 3Terms and definitions5 4General requirements applying to the biological evaluation of intraocular lens
15、es5 5Physicochemical tests 6 5.1General6 5.2Test for extractables and hydrolytic stability .6 5.3Degradation tests.6 Annex A (normative) Test for extractables and hydrolytic stability 8 Annex B (normative) Test of photostability12 Annex C (normative) Nd-YAG laser exposure test 14 Annex D (normative)
16、 Ocular implantation test.15 Annex E (informative) Selected definitions.18 Annex ZA (informative) A-deviations.19 Bibliography20 Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:52:18 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 3 EN 13503-5:2001 Foreword This document has been prepared
17、by 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 September 2001, and conflicting national standards
18、shall be withdrawn at the latest by September 2001. EN 13503 was developed by CEN/TC 170, Ophthalmic 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
19、Part 2: Optical properties and test methods Part 3: Mechanical properties and test methods Part 4: 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 ma
20、in difference between both series of standards is that ISO 11979 is based on the reference to ISO 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. Modifications of this part of EN 13503 co
21、mpared with ISO 11979-5 are indicated as follows: - text which has been deleted is striked out; - text which has been changed or added is underlined. This Part 5 of EN 13503 contains four normative annexes, A to D, and one informative annex, Annex E. According to the CEN/CENELEC Internal Regulations
22、, 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, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United
23、Kingdom. Endorsement notice The text of the International Standard ISO 11979-5:1999 was approved by CEN as a European Standard with agreed commun modifications as given in the Foreword and indicated in the text by strike-out and underlining. NOTEA-deviations are given in Annex ZA (informative). Lice
24、nsed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:52:18 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 4 EN 13503-5:2001 Introduction EN ISO 10993-1 indicates the fundamental principles governing the biological evaluation of medical devices, the definition of categories based on the nature and
25、duration of contact with the body, and selection of appropriate tests. Other parts of EN ISO 10993 present biological test methods, tests for ethylene oxide residues, tests for degradation and principles for sample preparation. NOTE It always was and still is the intention of the Technical Committee
26、s 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 series, problems were encountered with normative references to the existing ISO 14155 and EN 540 horizontal st
27、andards 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 preparation of identical International and European Standards on the clinical investigation of intraocular lenses. As a
28、 result, two different standards series have had to be prepared. It is the intention of ISO/TC 172/SC 7 and CEN/TC 170 to revise these standards with the goal to end up with identical ones as soon as identical ISO and CEN horizontal standards on clinical investigations become available. Licensed Cop
29、y: sheffieldun sheffieldun, na, Sun Oct 29 08:52:18 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 5 EN 13503-5:2001 1 Scope This part of EN 13503 ISO 11979 specifies particular requirements for the the biological evaluation of intraocular lenses (IOLs) which are in addition to the requirements out
30、lined in the relevant parts of EN ISO 10993. It also gives guidance on conducting an ocular implantation test. 2 Normative references This European Standard incorporates by dated or undated references, provisions from other publications. These normative references are cited at the appropriate places
31、 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 refer
32、red to applies (including amendments). EN 1441 : 1997, Medical devices Risk analysis ISO 14971-1:1998, Medical devices - Risk management - Part 1: Application of risk analysis. EN ISO 10993-1: 1997, Biological evaluation of medical devices - Part 1: Evaluation and testing: EN 30993-6 ISO 10993-6 : 1
33、994, Biological evaluation of medical devices - Part 6: Tests for local effects after implantation. 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 1
34、3503-3 ISO 11979-3: 1999 Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods. 3 Terms and definitions For the purposes of this part of EN 13503 ISO 11979, the terms and definitions given in EN ISO 11979-1 apply. NOTE Some definitions from EN ISO 11979-1 are repr
35、oduced for information in Annex E. 4 General requirements applying to the biological evaluation of intraocular lenses An evaluation of biological safety shall be undertaken in accordance with the principles and requirements of EN ISO 10993-1. The evaluation of the biological safety of the test mater
36、ial shall include an assessment for risk in accordance with EN 1441 ISO 14971-1. The results of the tests described in clause 5 shall be included in the risk assessment. The material shall be either the final product or representative sample material which has undergone the same processing steps, in
37、cluding sterilization. Where representative sample material is used, the shape and size shall be justified. In addition, for each test material the results of the following physicochemical evaluations (see clause 5) shall be available. All extractions shall be performed using an aqueous solvent and
38、a lipophilic solvent, unless otherwise stated in the test method: a) extractables and hydrolytic stability; b) photostability against ultraviolet/visible (UV/Vis) irradiation; and c) stability against Nd-YAG laser exposure. Consideration of the need for an ocular implantation test shall be documente
39、d and justified. Where necessary, an ocular implantation test shall be conducted in line with the general principles in EN 30993-6 ISO 10993-6, supplemented as described in annex D. Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:52:18 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 6 EN 1
40、3503-5:2001 NOTEAs the mass of an intraocular lens is typically only about 20 mg, in general no systemic or chronic toxicity testing is required. 5 Physicochemical tests 5.1 General The objectives of this group of tests are: a) to quantify possible residues of synthesis and additives or impurities f
41、rom manufacturing; b) to quantify possible degradation products due to hydrolysis; c) to quantify leachable chemical components; and d) to facilitate an analysis of any risks introduced by toxic products which may result from processing, treatment in use, or ageing of the test material. 5.2 Test for
42、 extractables and hydrolytic stability The material shall be tested for extractables and hydrolytic stability in accordance with annex A, which specifies several different extraction conditions, including the extraction media, temperature and duration. For all conditions the following shall be obser
43、ved. ? The manufacturer shall be required to justify and document the reasons for selecting each solvent. ? The extraction media shall be qualitatively and quantitatively analysed for possible extractable components of the material, such as process contaminants, residual monomers, additives of any k
44、ind, and other extractable components. ? Before and after extraction, the test material shall be weighed and any change in mass shall be calculated. The test material underdoing hydrolysis testing shall be examined by light microscopy at 10x and by scanning electron microscopy (SEM) at 500x before a
45、nd after extraction. The test material shall be compared with nonhydrolysed material and shall exhibit no difference in surface appearance (e.g. bubbles, dendrites, breaks and fissures). Optical transmittance curves of the test material in the ultraviolet and visible spectral regions (UV/Vis) shall
46、be recorded before and after hydrolysis testing. By comparison of the spectra, assurance shall be obtained that no significant changes in spectral transmittance have occurred due to the testing. The results shall be evaluated to assess the risk for potentially harmful effects due to extractable comp
47、onents. The results of the tests described in annex A shall be recorded and included in the assessment for risk in accordance with EN 1441 ISO 14971-1 as discussed in clause 4. 5.3 Degradation tests 5.3.1 Test for photostability The test material shall be assessed for photostability in accordance wi
48、th annex B. The saline solution surrounding the test material during exposure shall be analysed for migrated components. No significant change shall be detected between the UV/Vis spectra of the test material before and after the exposure. For anterior chamber IOLs, it shall in addition be shown tha
49、t no significant change in mechanical properties of the irradiated test material has occurred, compared with non-irradiated test material. NOTEThe loops of implanted anterior chamber IOLs are exposed to radiation, hence the rationale for requiring mechanical testing after irradiation. Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:52:18 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Page 7 EN 13503-5:2001 5.3.2 Nd-YAG laser exposure test The effect of Nd-YAG laser exposure shall be tested in accordance with annex C. The physiological saline surrounding the