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1、a Date: 22 August 2008 Origin: International Latest date for receipt of comments: 30 November 2008 Project no.: 2008/00708 Responsible committee: CH/172/7 Eye implants Interested committees: Title: Draft BS ISO 15798 Ophthalmic implants - Ophthalmic viscosurgical devices Supersession information: If
2、 this document is published as a standard, the UK implementation of it will supersede BSENISO15798 : 2001 and partially supersede. NONE If you are aware of a current national standard which may be affected, please notify the secretary (contact details below). WARNING: THIS IS A DRAFT AND MUST NOT BE
3、 REGARDED OR USED AS A BRITISH STANDARD. THIS DRAFT IS NOT CURRENT BEYOND 30 November 2008. This draft is issued to allow comments from interested parties; all comments will be given consideration prior to publication. No acknowledgement will normally be sent. See overleaf for information on comment
4、ing. No copying is allowed, in any form, without prior written permission from BSI except as permitted under the Copyright, Designs and Patent Act 1988 or for circulation within a nominating organization for briefing purposes. Electronic circulation is limited to dissemination by e-mail within such
5、an organization by committee members. Further copies of this draft may be purchased from BSI Customer Services, Tel: +44(0) 20 8996 9001 or email . British, International and foreign standards are also available from BSI Customer Services. Information on the co-operating organizations represented on
6、 the committees referenced above may be obtained from the responsible committee secretary. Cross-references The British Standards which implement International or European publications referred to in this draft may be found via the British Standards Online Service on the BSI web site http:/. Direct
7、tel: +44 (0)208 996 7462 Responsible Committee Secretary: Mr Simon Merriman (BSI) E-mail: Draft for Public Comment Head Office 389 Chiswick High Road London W4 4AL Telephone: +44(0)20 8996 9000 Fax: +44(0)20 8996 7001 Form 36 Version 8.0 DPC: 08/30178723 DC Licensed CopyChinese University of Hong K
8、ong, 21/10/2008 08:06, Uncontrolled Copy, (c) BSI b Introduction This draft standard is based on international discussions in which the UK has taken an active part. Your comments on this draft are invited and will assist in the preparation of the consequent standard. Comments submitted will be revie
9、wed by the relevant BSI committee before sending the consensus UK vote and comments to the international secretariat, which will then decide appropriate action on the draft and the comments received. If no comments are received to the contrary, then the UK will approve this draft. If the internation
10、al standard is approved, it is possible the text will be published as an identical British Standard. UK Vote Please indicate whether you consider the UK should submit a negative (with reasons) or positive vote on this draft. Submission The guidance given below is intended to ensure that all comments
11、 receive efficient and appropriate attention by the responsible BSI committee. Annotated drafts are not acceptable and will be rejected. All comments must be submitted, preferably electronically, to the Responsible Committee Secretary at the address given on the front cover. Comments should be compa
12、tible with Version 6.0 or Version 97 of Microsoft Word for Windows, if possible; otherwise comments in ASCII text format are acceptable. Any comments not submitted electronically should still adhere to these format requirements. All comments submitted should be presented as given in the example belo
13、w. Further information on submitting comments and how to obtain a blank electronic version of a comment form are available from the BSI web site at: http:/ Template for comments and secretariat observations Date: xx/xx/200x Document: ISO/DIS xxxxx 1 2 (3) 4 5 (6) (7) MB Clause No./ Subclause No./ An
14、nex (e.g. 3.1) Paragraph/ Figure/Table/ Note (e.g. Table 1) Type of com- ment Comment (justification for change) by the MB Proposed change by the MB Secretariat observations on each comment submitted 3.1 Definition 1 ed Definition is ambiguous and needs clarifying. Amend to read . so that the mains
15、connector to which no connection . 6.4 Paragraph 2 te The use of the UV photometer as an alternative cannot be supported as serious problems have been encountered in its use in the UK. Delete reference to UV photometer. Microsoft and MS-DOS are registered trademarks, and Windows is a trademark of Mi
16、crosoft Corporation. Licensed CopyChinese University of Hong Kong, 21/10/2008 08:06, Uncontrolled Copy, (c) BSI THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS THEREFORE SUBJECT TO CHANGE AND MAY NOT BE REFERRED TO AS AN INTERNATIONAL STANDARD UNTIL PUBLISHED AS SUCH. IN ADDITION
17、 TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL, TECHNOLOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT INTERNATIONAL STANDARDS MAY ON OCCASION HAVE TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL TO BECOME STANDARDS TO WHICH REFERENCE MAY BE MADE IN NATIONAL REGULATIONS. RECIPIENTS OF THIS DRA
18、FT ARE INVITED TO SUBMIT, WITH THEIR COMMENTS, NOTIFICATION OF ANY RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE AND TO PROVIDE SUPPORTING DOCUMENTATION. DRAFT INTERNATIONAL STANDARD ISO/DIS 15798 International Organization for Standardization, 2008 INTERNATIONAL ORGANIZATION FOR STANDARDIZATION OR
19、GANISATION INTERNATIONALE DE NORMALISATION ISO/TC 172/SC 7 Voting begins on: 2008-08-14 Secretariat: DIN Voting terminates on: 2009-01-14 Ophthalmic implants Ophthalmic viscosurgical devices Implants ophtalmiques Dispositifs ophtalmiques viscolastiques Revision of first edition (ISO 15798:2001) ICS
20、11.040.70 ISO/CEN PARALLEL ENQUIRY The CEN Secretary-General has advised the ISO Secretary-General that this ISO/DIS covers a subject of interest to European standardization. In accordance with the ISO-lead mode of collaboration as defined in the Vienna Agreement, consultation on this ISO/DIS has th
21、e same effect for CEN members as would a CEN enquiry on a draft European Standard. Should this draft be accepted, a final draft, established on the basis of comments received, will be submitted to a parallel two-month FDIS vote in ISO and formal vote in CEN. In accordance with the provisions of Coun
22、cil Resolution 15/1993 this document is circulated in the English language only. Conformment aux dispositions de la Rsolution du Conseil 15/1993, ce document est distribu en version anglaise seulement. To expedite distribution, this document is circulated as received from the committee secretariat.
23、ISO Central Secretariat work of editing and text composition will be undertaken at publication stage. Pour acclrer la distribution, le prsent document est distribu tel quil est parvenu du secrtariat du comit. Le travail de rdaction et de composition de texte sera effectu au Secrtariat central de lIS
24、O au stade de publication. Licensed CopyChinese University of Hong Kong, 21/10/2008 08:06, Uncontrolled Copy, (c) BSI ISO/DIS 15798 ii ISO 2008 All rights reserved PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes licensing policy, this file may be printed or vie
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27、for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below. Copyright notice This ISO document is a Draft International Standard and is copyright-protected by ISO. Except as permitted under the applicab
28、le laws of the users country, neither this ISO draft nor any extract from it may be reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic, photocopying, recording or otherwise, without prior written permission being secured. Requests for permission to reprod
29、uce should be addressed to either ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Reproduction may be subject to royalty payments
30、or a licensing agreement. Violators may be prosecuted. Licensed CopyChinese University of Hong Kong, 21/10/2008 08:06, Uncontrolled Copy, (c) BSI ISO/DIS 15798 ISO 2008 All rights reserved iii Contents Page Foreword .v 1 Scope1 2 Normative references1 3 Terms and definitions.2 4 Intended performance
31、.4 5 Design attributes.4 5.1 General .4 5.2 Characterization of the components.4 5.2.1 Chemical description4 5.3 Characterization of the finished product4 5.3.1 General .4 5.3.2 Absolute complex viscosity.4 5.3.3 Chemical and biological contaminants.5 5.3.4 Concentration5 5.3.5 Elasticity.5 5.3.6 Mo
32、lecular mass distribution.5 5.3.7 Osmolality5 5.3.8 Particulates5 5.3.9 pH6 5.3.10 Refractive index.6 5.3.11 Shear viscosity6 5.3.12 Spectral transmittance6 6 Design evaluation7 6.1 General .7 6.2 Evaluation of biological safety.7 6.2.1 General .7 6.2.2 Bacterial endotoxins test7 6.2.3 Clearance of
33、residual OVD from the anterior chamber.7 6.2.4 Degradation and toxicokinetics.7 6.2.5 Evaluation of inflammation and intraocular pressure.7 6.3 Clinical evaluation.8 6.3.1 General .8 6.3.2 Clinical investigation design8 6.3.3 Corneal endothelial cell density 9 6.3.4 Postoperative inflammation .9 6.3
34、.5 Post-operative intra-ocular pressure change.9 6.3.6 Adverse events9 7 Sterilization10 8 Product stability 10 9 Integrity and performance of the delivery system.10 10 Packaging.10 10.1 Protection from damage during storage and transport 10 10.2 Maintenance of sterility in transit11 11 Information
35、to be supplied by the manufacturer .11 Annex A (normative) Intraocular implantation test.13 A.1 General .13 Licensed CopyChinese University of Hong Kong, 21/10/2008 08:06, Uncontrolled Copy, (c) BSI ISO/DIS 15798 iv ISO 2008 All rights reserved A.2 Test material 13 A.3 Control material 13 A.4 Test p
36、rocedure 13 A.5 Test evaluation 14 A.5.1 Intraocular pressure evaluation 14 A.5.2 Inflammatory response evaluation . 14 A.6 Test report. 15 Annex B (informative) Patient numbers for clinical investigation of intra-ocular pressure. 16 Bibliography. 17 Licensed CopyChinese University of Hong Kong, 21/
37、10/2008 08:06, Uncontrolled Copy, (c) BSI ISO/DIS 15798 ISO 2008 All rights reserved v Foreword ISO (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 t
38、hrough 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, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO colla
39、borates 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 Directives, Part 2. The main task of technical committees is to prepare International Sta
40、ndards. 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 elements o
41、f this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 15798 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 7, Ophthalmic optics and instruments and by Technical Committee CEN/TC
42、 170, Ophthalmic optics in collaboration. This second edition cancels and replaces the first edition (EN ISO 15798:2001) which has been technically revised. Licensed CopyChinese University of Hong Kong, 21/10/2008 08:06, Uncontrolled Copy, (c) BSI Licensed CopyChinese University of Hong Kong, 21/10/
43、2008 08:06, Uncontrolled Copy, (c) BSI DRAFT INTERNATIONAL STANDARD ISO/DIS 15798 ISO 2008 All rights reserved 1 Ophthalmic implants Ophthalmic viscosurgical devices 1 Scope This International Standard applies to ophthalmic viscosurgical devices (OVDs), a class of non-active surgical implants with v
44、iscous and/or viscoelastic properties, intended for use during surgery in the anterior segment of the human eye. OVDs are designed to create and maintain space, to protect intra-ocular tissues and to manipulate tissues during surgery. This International Standard defines requirements with regard to s
45、afety for the intended performance, design attributes, preclinical and clinical evaluation, sterilization, product packaging, product labelling and information supplied by the manufacturer of these devices. 2 Normative references The following referenced documents are indispensable for the applicati
46、on of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing ISO 10993-2, Biological evaluation
47、 of medical devices Part 2: Animal welfare requirements ISO 10993-6, Biological evaluation of medical devices Part 6: Tests for local effects after implantation ISO 10993-9, Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation prod
48、ucts ISO 10993-16, Biological evaluation of medical devices Part 16: Toxicokinetic study design for degradation products and leachables ISO 11135-1, Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process fo
49、r medical devices ISO 11137, Sterilization of health care products Requirements for validation and routine control Radiation sterilization ISO 11607-1, Packaging for terminally sterilized medical devices ISO 13408-1, Aseptic processing of health care products Part 1: General requirements ISO 14155-1, Clinical investigation of medical devic