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. ISBN 978-0-626-20435-8 SANS 10993-10:2004Edition 1 and ISO amdt 1ISO 10993-10:2002Edition 2 and amdt 1 SOUTH AFRICAN NATIONAL STANDARD Biological evaluat
4、ion of medical devices Part 10: Tests for irritation and delayed-type hypersensitivity This national standard is the identical implementation of ISO 10993-10:2002 and ISO amendment 1, and is adopted with the permission of the International Organization for Standardization. Published by Standards Sou
5、th Africa 1 dr lategan road groenkloof 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 10993-10:2004 Edition 1 and ISO amdt 1 ISO 10993-10:2002 Edition 2 and amdt 1 Table of changes Change No. Date Scope ISO a
6、mdt 1 2006 Amended to correct information in the scope regarding the use of devices, to modify the definition of solvent (3.16), to clarify a requirement in the step-wise approach (4(d) and to add a note to this requirement, to correct time periods for clinical observation and grading of skin reacti
7、ons (6.4.4.3.5) and for the response rate results given in the test report of the human skin irritation test (6.4.5.3(e), to correct the editorial errors in the preliminary tests for the maximization test for delayed hypersensitivity (7.4.4.2) and in the induction phase of the main test of the close
8、d-patch test for delayed hypersensitivity (7.5.4.3.1), to change the title for annex B and the general requirement (B.1) accordingly, to correct information regarding the degree of opacity of the cornea in table B.2, to correct editorial errors in the test procedure in B.4.6 and in the macroscopic e
9、valuation in the assessment of results (B.4.8.1 and B.5.8.1), to give the corrected full title of RTECS (C.1), and to correct an editorial error regarding the OECD draft guideline (C.1). National foreword This South African standard was approved by National Committee StanSA SC 5140.37E, Medical devi
10、ces 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. This SANS document was published in January 2008. This SANS document supersedes SANS 10993-10:2004 (edition 1). Referen
11、ce numberISO 10993-10:2002/Amd.1:2006(E)ISO 2006INTERNATIONAL STANDARD ISO10993-10Second edition2002-09-01AMENDMENT 12006-07-15Biological evaluation of medical devices Part 10: Tests for irritation and delayed-type hypersensitivity AMENDMENT 1 valuation biologique des dispositifs mdicaux Partie 10:
12、Essais dirritation et dhypersensibilit retarde AMENDEMENT 1 SANS 10993-10:2004This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 10993-10:2002/Amd.1:2006(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adob
13、es 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. In downloading this file, parties accept therein the responsibility of not infringing Adobes licensing policy.
14、 The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care
15、 has been taken to ensure that the file is suitable 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. ISO 2006 All rights reserved. Unless otherwise specified, no part of this publication may
16、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 ISOs member body in the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. +
17、 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2006 All rights reservedSANS 10993-10:2004This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 10993-10:2002/Amd.1:2006(E) ISO 2006
18、All rights reserved iiiForeword 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 through ISO technical committees. Each member body interested in
19、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 collaborates closely with the International Electrotechnical Commissi
20、on (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 Standards. Draft International Standards adopted by the technical c
21、ommittees 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 of this document may be the subject of patent rights. ISO shall n
22、ot be held responsible for identifying any or all such patent rights. Amendment 1 to ISO 10993-10:2002 was prepared by Technical Committee ISO/TC 194, Biological evaluation of medical devices. SANS 10993-10:2004This s tandard may only be used and printed by approved subscription and freemailing clie
23、nts of the SABS .SANS 10993-10:2004This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 10993-10:2002/Amd.1:2006(E) ISO 2006 All rights reserved 1Biological evaluation of medical devices Part 10: Tests for irritation and delayed-type hypersens
24、itivity AMENDMENT 10 Page 1, Clause 1 In the last paragraph, replace “used intradermally in the ocular, oral, rectal, penile and vaginal areas” by the following: “used intradermally and in the ocular, oral, rectal, penile and vaginal areas”. Page 3, definition 3.16 Replace “substance material” by “s
25、ubstance/material”. Page 4, Clause 4 d) In the last paragraph, replace the current text by the following: “A test of positive-control substance for skin sensitisation 7 shall be run in a minimum of ten test animals and five control animals at least every six months by the testing laboratory to verif
26、y the test system and demonstrate a positive response.” Add to 4 d) last paragraph a NOTE: NOTE Fewer animals may be used when an assay with a positive control substance is performed more frequently than once every six months. It is advisable to use at least five test animals with a positive substan
27、ce and five control animals. Page 12, subclause 6.4.4.3.5 Replace first sentence by the following: “Treatment sites are examined for signs of irritation and the responses are scored immediately after patch removal and at 1 h to 2 h, 24 h, 48 h and 72 h after patch removal.” Page 13, subclause 6.4.5.
28、3 e) Replace first dash by the following: “response rate at 0 h, 1 h to 2 h, 24 h, 48 h and 72 h and at any other times scored.” Page 16, subclause 7.4.4.2 In the fourth paragraph, replace “ibnduction” by “induction” and replace “move” by “more” SANS 10993-10:2004This s tandard may only be used and
29、printed by approved subscription and freemailing clients of the SABS .ISO 10993-10:2002/Amd.1:2006(E) 2 ISO 2006 All rights reservedPage 19, subclause 7.5.4.3.1 In the third sentence, delete “consecutive” and substitute “Perform” for “Repeat” Page 23, Annex B Change “Informative” to “Normative” and
30、replace the title by “Special irritation tests”. In Annex B.1, replace text by the following: “The following special irritation tests exist. These tests are relevant for medical devices intended to be applied to specific areas. If used, a rationale shall be provided for the choice of the test method
31、.” Page 29, Table B.2 Under “1 Cornea” replace, “Opaque iris visible” by “Opaque, details of iris not visible”. Page 30, subclause B.4.6 In the first sentence, replace “check” by “cheek”. Page 31, subclause B.4.8.1 In the first paragraph change “untreated” to “treated”. Page 35, subclause B.5.8.1 In
32、 the first paragraph, change “untreated” to “treated”. Page 41, Clause C.1 In the second paragraph, replace “Registry of Toxic Effects of Chemical Materials (RTECS)” by “Registry of Toxic Effects of Chemical Substances (RTECS)”. In the last paragraph, replace “OECD Guideline Draft on Acute Dermal Ir
33、ritation study in human volunteers” by “OECD Draft Guideline on Acute Dermal Irritation Study in Human Volunteers”. SANS 10993-10:2004This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .Reference numberISO 10993-10:2002(E)ISO 2002INTERNATIONAL ST
34、ANDARD ISO10993-10Second edition2002-09-01Biological evaluation of medical devices Part 10: Tests for irritation and delayed-type hypersensitivity valuation biologique des dispositifs mdicaux Partie 10: Essais dirritation et dhypersensibilit retarde SANS 10993-10:2004This s tandard may only be used
35、and printed by approved subscription and freemailing clients of the SABS .ISO 10993-10:2002(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 a
36、re licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobes licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Detai
37、ls of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem re
38、lating to it is found, please inform the Central Secretariat at the address given below. ISO 2002 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, wi
39、thout permission in writing from 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.ch Web www.iso.ch Printed in Switzerland ii ISO 2002 All right
40、s reservedSANS 10993-10:2004This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 10993-10:2002(E) ISO 2002 All rights reserved iiiContents Page Foreword iv Introduction vi 1 Scope 1 2 Normative references 1 3 Terms and definitions. 2 4 General
41、 principles Step-wise approach . 3 5 Pretest considerations 4 5.1 General . 4 5.2 Types of material. 4 5.3 Information on chemical composition 4 5.4 Material characterization 5 6 Irritation tests 5 6.1 In vitro irritation tests . 5 6.2 Factors to be considered in design and selection of in vivo test
42、s 5 6.3 Animal skin irritation test . 6 6.4 Human skin irritation test. 10 7 Delayed hypersensitivity tests. 14 7.1 Choice of test. 14 7.2 Choice of test sample concentrations 14 7.3 Other important factors affecting the outcome of the test . 14 7.4 Maximization test for delayed hypersensitivity . 1
43、5 7.5 Closed-patch test for delayed hypersensitivity . 18 8 Key factors in interpretation of test results 20 Annex A (normative) Preparation of materials for irritation/sensitization testing. 21 Annex B (informative) Additional irritation tests.23 Annex C (informative) Background information 41 Bibl
44、iography 45 SANS 10993-10:2004This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 10993-10:2002(E) iv ISO 2002 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide federation of national standard
45、s bodies (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 organiz
46、ations, 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
47、the ISO/IEC Directives, Part 3. 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 % o
48、f the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this part of ISO 10993 may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 10993-10 was prepared by Technical Committee ISO/TC
49、194, Biological evaluation of medical devices. This second edition cancels and replaces the first edition (ISO 10993-10:1995), 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: Animal 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
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