1、 Collection of SANS standards in electronic format (PDF) 1. Copyright This standard is available to staff members of companies that have subscribed to the complete collection of SANS standards in accordance with a formal copyright agreement. This document may reside on a CENTRAL FILE SERVER or INTRA
2、NET SYSTEM only. Unless specific permission has been granted, this document MAY NOT be sent or given to staff members from other companies or organizations. Doing so would constitute a VIOLATION of SABS copyright rules. 2. Indemnity The South African Bureau of Standards accepts no liability for any
3、damage whatsoever than may result from the use of this material or the information contain therein, irrespective of the cause and quantum thereof. ICS 11.100 ISBN 0-626-16050-2 SANS 10993-3:2004Edition 1ISO 10993-3:2003Edition 2SOUTH AFRICAN NATIONAL STANDARD Biological evaluation of medical devices
4、 Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity This national standard is the identical implementation of ISO 10993-3:2003 and is adopted with the permission of the International Organization for Standardization. Published by Standards South Africa 1 dr lategan road groenk
5、loof private bag x191 pretoria 0001 tel: 012 428 7911 fax: 012 344 1568 international code + 27 12 www.stansa.co.za Standards South Africa SANS 10993-3:2004 Edition 1 ISO 10993-3:2003 Edition 2 Table of changes Change No. Date Scope Abstract Specifies strategies for hazard identification and tests o
6、n medical devices for the following biological aspects: genotoxicity, carcinogenicity, and reproductive and developmental toxicity. This part of SANS 10993 is applicable for evaluation of a medical device whose potential for genotoxicity, carcinogenicity or reproductive toxicity has been identified.
7、 Keywords bioassay, carcinogens, definitions, dental equipment, dental instruments, genotoxic, genotoxical materials, genotoxicity, implants (surgical), medical equipment, medical sciences, medicine, surgical equipment, surgical implants, testing, toxicity. National foreword This South African stand
8、ard was approved by National Committee StanSA SC 5140.37E, Medical devices Healthcare devices and materials for use in clinics and hospitals, in accordance with procedures of Standards South Africa, in compliance with annex 3 of the WTO/TBT agreement. Reference numberISO 10993-3:2003(E)ISO 2003INTER
9、NATIONAL STANDARD ISO10993-3Second edition2003-10-15Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity valuation biologique des dispositifs mdicaux Partie 3: Essais concernant la gnotoxicit, la cancrognicit et la toxicit sur la reproduc
10、tion ISO 10993-3:2003(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. I
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13、dress given below. ISO 2003 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or IS
14、Os 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 Published in Switzerland ii ISO 2003 All rights reservedISO 10993-3:2003(E) ISO 2003 All rights reserved iiiCont
15、ents Page Foreword iv Introduction . vi 1 Scope 1 2 Normative references . 1 3 Terms and definitions. 2 4 Genotoxicity tests . 3 4.1 General. 3 4.2 Test strategy 3 4.3 Sample preparation. 4 4.4 Test methods. 4 4.4.1 In vitro genotoxicity tests. 4 4.4.2 In vivo genotoxicity tests . 4 5 Carcinogenicit
16、y tests 5 5.1 General. 5 5.2 Test strategy 5 5.3 Sample preparation. 5 5.4 Test methods. 5 6 Reproductive and developmental toxicity tests 6 6.1 General. 6 6.2 Test strategy 6 6.3 Sample preparation. 6 6.4 Test methods. 7 7 Test report 7 Annex A (informative) Cell transformation test system . 8 Anne
17、x B (informative) Rationale of test systems 9 Annex C (informative) Role of implantation carcinogenicity studies 11 Bibliography . 13 ISO 10993-3:2003(E) iv ISO 2003 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards b
18、odies (ISO member 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 organizati
19、ons, governmental 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
20、 ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. 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 t
21、he member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 10993-3 was prepared by Technical Committee ISO/TC 194, Biologic
22、al evaluation of medical devices. This second edition cancels and replaces the first edition (ISO 10993-3:1992), which has been technically revised. ISO 10993 consists of the following parts, under the general title Biological evaluation of medical devices: Part 1: Evaluation and testing Part 2: Ani
23、mal welfare requirements Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity Part 4: Selection of tests for interactions with blood Part 5: Tests for in vitro cytotoxicity Part 6: Tests for local effects after implantation Part 7: Ethylene oxide sterilization residuals Part 8:
24、Selection and qualification of reference materials for biological tests Part 9: Framework for the identification and quantification of potential degradation products Part 10: Tests for irritation and delayed-type hypersensitivity Part 11: Tests for systemic toxicity Part 12: Sample preparation and r
25、eference materials Part 13: Identification and quantification of degradation products from polymeric medical devices Part 14: Identification and quantification of degradation products from ceramics ISO 10993-3:2003(E) ISO 2003 All rights reserved v Part 15: Identification and quantification of degra
26、dation products from metals and alloys Part 16: Toxicokinetic study design for degradation products and leachables Part 17: Establishment of allowable limits for leachable substances Part 18: Chemical characterization of materials Future parts will deal with other relevant aspects of biological test
27、ing. ISO 10993-3:2003(E) vi ISO 2003 All rights reservedIntroduction The basis for biological evaluation of medical devices is often empirical and driven by the relevant concerns for human safety. The risk of serious and irreversible effects, such as cancer or second-generation abnormalities, is of
28、particular public concern. It is inherent in the provision of safe medical devices that such risks be minimized to the greatest extent feasible. The assessment of mutagenic, carcinogenic and reproductive hazards is an essential component of the control of these risks. Not all test methods for the as
29、sessment of genotoxicity, carcinogenicity or reproductive toxicity are equally well developed, nor is their validity well established for the testing of medical devices. Significant issues in test sample size and preparation, scientific understanding of disease processes and test validation can be c
30、ited as limitations of available methods. For example, the biological significance of solid state carcinogenesis is poorly understood. It is expected that ongoing scientific and medical advances will alter our understanding of and approaches to these important toxicity test methods. At the time this
31、 part of ISO 10993 was prepared, the test methods proposed were those most acceptable. Scientifically sound alternatives to the proposed testing may be acceptable insofar as they address relevant matters of safety assessment. In the selection of tests needed to evaluate a particular medical device,
32、there is no substitute for a careful assessment of expected human uses and potential interactions of the medical device with various biological systems. These considerations will be particularly important in such areas as reproductive and developmental toxicology. This part of ISO 10993 presents tes
33、t methods for the detection of specific biological hazards, and strategies for the selection of tests, where appropriate, that will assist in hazard identification. Testing is not always necessary or helpful in hazard identification but, where it is appropriate, it is important that maximum test sen
34、sitivity be achieved. Most tests included in this part of ISO 10993 refer to Guidelines for Testing of Chemicals, prepared by the Organization for Economic Cooperation and Development (OECD). The interpretation of findings and their implications for human health effects are beyond the scope of this
35、part of ISO 10993. Because of the multitude of possible outcomes and the importance of factors such as extent of exposure, species differences and mechanical or physical considerations, risk assessment has to be performed on a case-by-case basis. INTERNATIONAL STANDARD ISO 10993-3:2003(E) ISO 2003 A
36、ll rights reserved 1Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity 1 Scope This part of ISO 10993 specifies strategies for hazard identification and tests on medical devices for the following biological aspects: genotoxicity, carcin
37、ogenicity, and reproductive and developmental toxicity. This part of ISO 10993 is applicable for evaluation of a medical device whose potential for genotoxicity, carcinogenicity or reproductive toxicity has been identified. NOTE Guidance on selection of tests is provided in ISO 10993-1. 2 Normative
38、references The following referenced documents are indispensable for the application 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 10993-1:1997, Biological evaluatio
39、n of medical devices Part 1: Evaluation and testing ISO 10993-2:1992, Biological evaluation of medical devices Part 2: Animal welfare requirements ISO 10993-6:1994, Biological evaluation of medical devices Part 6: Tests for local effects after implantation ISO 10993-12:2002, Biological evaluation of
40、 medical devices Part 12: Sample preparation and reference materials ISO 10993-18, Biological evaluation of medical devices Part 18: Chemical characterization of materials. OECD 4141), Prenatal Development Toxicity Study OECD 415, One-Generation Reproduction Toxicity Study OECD 416, Two-Generation R
41、eproduction Toxicity 1) Organization for Economic Cooperation and Development. ISO 10993-3:2003(E) 2 ISO 2003 All rights reservedOECD 421, Reproduction/Developmental Toxicity Screening Test OECD 451, Carcinogenicity Studies OECD 453, Combined Chronic Toxicity/Carcinogenicity Studies OECD 471, Bacter
42、ial Reverse Mutation Test OECD 473, In vitro Mammalian Chromosome Aberration Test OECD 476, In vitro Mammalian Cell Gene Mutation Test 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 10993-1, ISO 10993-12 and the following apply. 3.1 carcinogenicity
43、test test to determine the tumorigenic potential of medical devices, materials and/or extracts using either single or multiple exposures over a major portion of the life span of the test animal NOTE These tests may be designed to examine both chronic toxicity and tumorigenicity in a single experimen
44、tal study. When chronic toxicity and carcinogenicity are evaluated within a single study, care in study design with emphasis on dose selection should be exercised. This will help to ensure that premature mortality from chronic/cumulative toxicity does not compromise the statistical evaluation of ani
45、mals that survive until scheduled study termination (i.e. normal life-span). 3.2 energy-depositing medical device device intended to exert its therapeutic or diagnostic effect by the delivery of electromagnetic radiation, ionizing radiation or ultrasound NOTE This does not include medical devices th
46、at deliver simple electrical current, such as electrocautery medical devices, pacemakers or functional electrical stimulators. 3.3 genotoxicity test test using mammalian or non-mammalian cells, bacteria, yeasts or fungi to determine whether gene mutations, changes in chromosome structure, or other D
47、NA or gene changes are caused by the test samples NOTE These tests can include whole animals. 3.4 maximum tolerated dose MTD maximum dose that a test animal can tolerate without any adverse physical effects 3.5 reproductive and developmental toxicity test test to evaluate the potential effects of te
48、st samples on reproductive function, embryonic morphology (teratogenicity), and prenatal and early postnatal development ISO 10993-3:2003(E) ISO 2003 All rights reserved 34 Genotoxicity tests 4.1 General Before a decision to perform a genotoxicity test is made, ISO 10993-1 and the chemical character
49、ization of materials (ISO 10993-18) shall be taken into account. The rationale for a test programme, taking into consideration all relevant factors, shall be documented. ISO 10993-1 indicates circumstances where the potential for genotoxicity is a relevant hazard for consideration in an overall biological safety evaluation (see ISO 10993-1:1997, Table 1). Testing for genotoxicity, however, is not necessary for medical devices, and components thereof, made only from materials known to
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