1、December 2013 Translation by DIN-Sprachendienst.English price group 18No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).I
2、CS 11.100.20; 11.060.10!%*r“2077993www.din.deDDIN EN ISO 7405Dentistry Evaluation of biocompatibility of medical devices used in dentistry(ISO 7405:2008 + Amd. 1:2013);English version EN ISO 7405:2008 + A1:2013,English translation of DIN EN ISO 7405:2013-12Zahnheilkunde Beurteilung der Biokompatibil
3、itt von in der Zahnheilkunde verwendeten Medizinprodukten(ISO 7405:2008 + Amd. 1:2013);Englische Fassung EN ISO 7405:2008 + A1:2013,Englische bersetzung von DIN EN ISO 7405:2013-12SupersedesDIN EN ISO 7405:2009-06www.beuth.deDocument comprises pagesIn case of doubt, the German-language original shal
4、l be considered authoritative.42(ISO 7405:2008 + Amd. 1:2013);Version anglaise EN ISO 7405:2008 + A1:2013,Traduction anglaise de DIN EN ISO 7405:2013-12!Mdecine bucco-dentaire valuation de la biocompatibilit des dispositifs mdicaux utiliss en mdecine bucco-dentaire“ 12.13 DIN EN ISO 7405:2013-12 2 A
5、 comma is used as the decimal marker. National foreword This document (EN ISO 7405:2008 + A1:2013) has been prepared by Technical Committee ISO/TC 106 “Dentistry” (Secretariat: SCC, Canada) in collaboration with Technical Committee CEN/TC 55 “Dentistry” (Secretariat: DIN, Germany). The responsible G
6、erman body involved in its preparation was the Normenausschuss Dental (Dentistry Standards Committee), Working Committee NA 014-00-20 AA Biologische und klinische Werkstoffprfung. This standard includes Amendment A1 approved by CEN on 2013-05-15. The start and finish of text introduced or altered by
7、 amendment is indicated in the text by tags !“. The DIN Standards corresponding to the International Standards referred to in Clause 2 of this standard are as follows: ISO 1942 DIN EN ISO 1942 ISO 6344-1 DIN ISO 6344-1 ISO 10993-1 DIN EN ISO 10993-1 ISO 10993-2 DIN EN ISO 10993-2 ISO 10993-3 DIN EN
8、ISO 10993-3 ISO 10993-5 DIN EN ISO 10993-5 ISO 10993-6 DIN EN ISO 10993-6 ISO 10993-9 DIN EN ISO 10993-9 ISO 10993-10 DIN EN ISO 10993-10 ISO 10993-11 DIN EN ISO 10993-11 ISO 10993-12 DIN EN ISO 10993-12 ISO 14971 DIN EN ISO 14971 Amendments This standard differs from DIN EN ISO 7405:2009-06 as foll
9、ows: a) Subclause 6.1.5 “Positive control material” has been added; b) the French title has been modified; c) reference 31 has been added to the Bibliography. Previous editions DIN V 13930: 1987-05, 1990-09 DIN EN ISO 7405: 1998-01, 2009-06 DIN EN ISO 7405:2013-12 3 National Annex NA (informative) B
10、ibliography DIN EN ISO 1942, Dentistry Vocabulary DIN EN ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management system DIN EN ISO 10993-2, Biological evaluation of medical devices Part 2: Animal welfare requirements DIN EN ISO 10993-3, Biologica
11、l evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity DIN EN ISO 10993-5, Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity DIN EN ISO 10993-6, Biological evaluation of medical devices Part 6: Tests for local effects
12、after implantation DIN EN ISO 10993-9, Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products DIN EN ISO 10993-10, Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization DIN EN ISO 1099
13、3-11, Biological evaluation of medical devices Part 11: Tests for systemic toxicity DIN EN ISO 10993-12, Biological evaluation of medical devices Part 12: Sample preparation and reference materials DIN EN ISO 14971, Medical devices Application of risk management to medical devices DIN ISO 6344-1, Co
14、ated abrasives Grain size analysis Part 1: Grain size distribution test DIN EN ISO 7405:2013-12 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 7405 December 2008 + A1 July 2013 ICS 11.060.10; 11.100.99 Supersedes EN ISO 7405:1997English Version Dentistry
15、- Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2008 + Amd 1:2013) !Mdecine bucco-dentaire - valuation de la biocompatibilit des dispositifs mdicaux utiliss en mdecine bucco-dentaire“ (ISO 7405:2008 + Amd 1:2013) Zahnheilkunde - Beurteilung der Biokompatibilitt von in
16、 der Zahnheilkunde verwendeten Medizinprodukten (ISO 7405:2008 + Amd 1:2013) EN ISO 7405:2013 was approved by CEN on 2008-12-05 and Amendment A1:2013 on 2013-05-15. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Stand
17、ard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (English
18、, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bul
19、garia, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, T
20、urkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2013 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. E
21、N ISO 7405:2008 + A1:2013 EContents Page Foreword to EN ISO 7405:2008 3!Foreword to EN ISO 7405:2008/A1:2013 .3Introduction .41 Scope 52 Normative references 53 Terms and definitions .64 Categorization of medical devices .74.1 Categorization by nature of contact 74.2 Categorization by duration of co
22、ntact .75 Biological evaluation process 85.1 General 85.2 Selection of tests and overall assessment .85.3 Selection of test methods .85.4 Types of test .95.5 Re-evaluation of biocompatibility 106 Test procedures specific to dental materials .106.1 Recommendations for sample preparation 106.2 Agar di
23、ffusion test .126.3 Filter diffusion test.146.4 Pulp and dentine usage test .176.5 Pulp capping test .216.6 Endodontic usage test 23Annex A (informative) Types of test to be considered for evaluation of biocompatibility of medical devices used in dentistry 27Annex B (informative) Dentine barrier cyt
24、otoxicity test 29 Annex C (informative) Acute toxicity testing 36Bibliography 3 DIN EN ISO 7405:2013-12 EN ISO 7405:2008 + A1:2013 (E) 2 7Foreword to EN ISO 7405:2008 This document (EN ISO 7405:2008) has been prepared by Technical Committee ISO/TC 106 “Dentistry” in collaboration with Technical Comm
25、ittee CEN/TC 55 “Dentistry” 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 December 2009, and conflicting national standards shall be withdrawn at the lat
26、est by December 2009. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 7405:1997. According to the CEN/
27、CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Lu
28、xembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 7405:2008 has been approved by CEN as EN ISO 7405:2008 without any modification. !Foreword to EN ISO 7405:2008/A1:2013 This docum
29、ent (EN ISO 7405:2008/A1:2013) has been prepared by Technical Committee ISO/TC 106 “Dentistry” in collaboration with Technical Committee CEN/TC 55 “Dentistry” the secretariat of which is held by DIN. This Amendment to the European Standard EN ISO 7405:2008 shall be given the status of a national sta
30、ndard, either by publication of an identical text or by endorsement, at the latest by January 2014, and conflicting national standards shall be withdrawn at the latest by January 2014. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent right
31、s. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cy
32、prus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the Unit
33、ed Kingdom. Endorsement notice The text of ISO 7405:2008/Amd 1:2013 has been approved by CEN as EN ISO 7405:2008/A1:2013 without any modification.“ DIN EN ISO 7405:2013-12 EN ISO 7405:2008 + A1:2013 (E) 3 Introduction This International Standard concerns the evaluation of the biocompatibility of med
34、ical devices used in dentistry. It is to be used in conjunction with the ISO 10993 series of standards. This International Standard contains special tests, for which ample experience exists in dentistry and which acknowledge the special needs of dentistry. Only test methods for which the members of
35、the committee considered there was sufficient published data have been included. In recommending test methods, the need to minimize the use of animals was given a high priority. It is essential that the decision to undertake tests involving animals be reached only after a full and careful review of
36、the evidence indicating that a similar outcome cannot be achieved by other types of test. In order to keep the number of animals required for tests to an absolute minimum, consistent with achieving the objective indicated, it can be appropriate to conduct more than one type of test on the same anima
37、l at the same time, e.g. pulp and dentin usage test and pulp capping test. However, in accordance with ISO 10993-2 these tests are performed both in an efficient and humane way. On all occasions when animal testing is undertaken, such tests are conducted empathetically and according to standardized
38、procedures as described for each test. This International Standard does not explicitly describe test methods for occupationally related risks. Annexes B and C are included to encourage the development of in vitro and ex vivo test methods which will further reduce the use of animals in the evaluation
39、 of the biocompatibility of medical devices used in dentistry. DIN EN ISO 7405:2013-12 EN ISO 7405:2008 + A1:2013 (E) 4 1 Scope This International Standard specifies test methods for the evaluation of biological effects of medical devices used in dentistry. It includes testing of pharmacological age
40、nts that are an integral part of the device under test. This International Standard does not cover testing of materials and devices that do not come into direct or indirect contact with the patients body. 2 Normative references The following referenced documents are indispensable for the application
41、 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 1942, Dentistry Vocabulary ISO 6344-1, Coated abrasives Grain size analysis Part 1: Grain size distribution test ISO
42、10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process ISO 10993-2, Biological evaluation of medical devices Part 2: Animal welfare requirements ISO 10993-3, Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogen
43、icity and reproductive toxicity ISO 10993-5, Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity ISO 10993-6, Biological evaluation of medical devices Part 6: Tests for local effects after implantation ISO 10993-101), Biological evaluation of medical devices Part 10: Tes
44、ts for irritation and skin sensitization ISO 10993-11, Biological evaluation of medical devices Part 11: Tests for systemic toxicity ISO 10993-12:2007, Biological evaluation of medical devices Part 12: Sample preparation and reference materials ISO 14971, Medical devices Application of risk manageme
45、nt to medical devices 1) To be published. DIN EN ISO 7405:2013-12 EN ISO 7405:2008 + A1:2013 (E) 5 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 1942, ISO 10993-1, ISO 10993-12 and the following apply. 3.1 medical device any instrument, apparatus,
46、appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software necessary for its proper application intended by the manufacturer to be used for medical purposes for human beings for the purpose of: diagnosis, prevention, mo
47、nitoring, treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap; investigation, replacement or modification of the anatomy or of a physiological process; control of conception; and which does not achieve its principal intended
48、 action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means 3.2 dental material material and/or substance or combination of materials and/or substances specially formulated and prepared for use in the practice of dentistry and/or associated procedures 3.3 final product medical device in its “as-used” state NOTE Many dental materials are used in a freshly mixed state, and evaluation of the materi
