EN ISO 7405-2008 en Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (Incorporates Amendment A1 2013)《牙科学 牙科用医疗器械生物相容性评估》.pdf

1、BSENISO7405:2008ICS 11.060.10; 11.100.20NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISHSTANDARDDentistryE valuationofbiocompatibilityofmedicaldevicesusedindentistry(ISO7405:2008)BS EN ISO 7405:2008 +A1:2013BS EN ISO 7405:2008+A1:2013ISBN 978 0 580 77340 2Amendments/corr

2、igenda issued since publicationDate Comments31 August 2013 Implementation of ISO amendment 1:2013 with CEN endorsement A1:2013This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 January 2009 The British Standards Institution 2013. Published by

3、 BSI Standards Limited 2013National forewordThis British Standard is the UK implementation of EN ISO 7405:2008+A1:2013. It is identical to ISO 7405:2008, incorporating amendment 1:2013. It supersedes BS EN ISO 7405:2008 which is withdrawn.The start and finish of text introduced or altered by amendme

4、nt is indicated in the text by tags. Tags indicating changes to ISO text carry the number of the ISO amendment. For example, text altered by ISO amendment 1 is indicated by .The UK participation in its preparation was entrusted to Technical Committee CH/106, Dentistry.A list of organizations represe

5、nted on this committee can be obtained on request to its secretary.The publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunity from legal obligations.EUROPEAN STAND

6、ARDNORME EUROPENNEEUROPISCHE NORMEN ISO 7405December 2008ICS 11.060.10; 11.100 Supersedes EN ISO 7405:1997 English VersionDentistry - Evaluation of biocompatibility of medical devicesused in dentistry (ISO 7405:2008)Art dentaire - valuation de la biocompatibilit desdispositifs mdicaux utiliss en art

7、 dentaire (ISO7405:2008)Zahnheilkunde - Beurteilung der Biokompatibilitt von in derZahnheilkunde verwendeten Medizinprodukten (ISO7405:2008)This European Standard was approved by CEN on 5 December 2008.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the cond

8、itions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the CEN Management Centre or to any CEN member.This European Standard exists in three

9、official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austri

10、a, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE

11、 FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGManagement Centre: rue de Stassart, 36 B-1050 Brussels 2008 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 7405:2008: EEN ISO 7405:2008+A1July 2013B

12、S EN ISO 7405:2008EN ISO 7405:2008 (E)3 Foreword This document (EN ISO 7405:2008) has been prepared by Technical Committee ISO/TC 106 “Dentistry“ incollaboration with Technical Committee CEN/TC 55 “Dentistry” the secretariat of which is held by DIN.This European Standard shall be given the status of

13、a national standard, either by publication of an identical text or byendorsement, at the latest by June 2009, and conflictingnational standards shall bewithdrawn atthe latest by June 2009.Attention is drawn to the possibility that some of the elements of this document may be the subject of patent ri

14、ghts. CEN and/or CENELEC shall not be held responsible for identifying any orall such patent rights. This document supersedes EN ISO 7405:1997.According to the CEN/CENELEC Internal Regulations, the national standards organizations of the followingcountries are bound to implement this European Standa

15、rd: Austria, Belgium, Bulgaria, Cyprus, CzechRepublic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the UnitedKingdom. Endo

16、rsement noticeThe text of ISO 7405:2008 has been approved by CEN as a EN ISO 7405:2008 without any modification.BS EN ISO 7405:2008+A1:2013EN ISO 7405:2008+A1:2013 (E)EN ISO 7405:2008/A1:2013 (E)3ForewordThis document (EN ISO 7405:2008/A1:2013) has been prepared by Technical Committee ISO/TC 106 “De

17、ntistry” 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 standard, either by publication of an identical text or by endorsement, at the latest by J

18、anuary 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 rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such pate

19、nt 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, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, F

20、rance, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.Endorsement noticeThe text of ISO 7405:2008/Amd 1:2013 has been approved by CE

21、N as EN ISO 7405:2008/A1:2013 without any modification.Foreword to amendment A1BS EN ISO 7405:2008ISO 7405:2008(E) ISO 2008 All rights reserved iiiContents PageForeword ivIntroduction.v1Scope12Normative references13Terms and definitions.24Categorization of medical devices 34.1 Categorization by natu

22、re of contact34.2 Categorization by duration of contact.35Biological evaluation process45.1 General .45.2 Selection of tests and overall assessment.45.3 Selection of test methods.45.4 Types of test 55.5 Re-evaluation of biocompatibility66Test procedures specific to dental materials.66.1 Recommendati

23、ons for sample preparation66.2 Agar diffusion test.86.3 Filter diffusion test106.4 Pulp and dentine usage test.136.5 Pulp capping test.176.6 Endodontic usage test19Annex A (informative) Types of test to be considered for evaluation of biocompatibility of medical devices used in dentistry23Annex B (i

24、nformative) Dentine barrier cytotoxicity test25Annex C (informative) Acute toxicity testing .32Bibliography33BS EN ISO 7405:2008+A1:2013ISO 7405:2008+A1:2013 (E)BS EN ISO 7405:2008ISO 7405:2008(E)iv ISO 2008 All rights reservedForeword ISO (the International Organization for Standardization) is a wo

25、rldwide 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 a subject for which a technical committee has beenestablished has the right to be represented on

26、 that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closelywith the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted i

27、n 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 Standardsadopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard r

28、equires 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 not be held responsible for identifying any or all such patent rights. ISO 7405 was prepared by Techn

29、ical Committee ISO/TC 106, Dentistry. This second edition cancels and replacesthe first edition (ISO 7405:1997) whichhas been technically revised.The following changes have been made: a) addition of dentine barrier cytotoxicity test to Annex B; b) improved description of test methods; c) updated cro

30、ss-references to ISO10993 series. BS EN ISO 7405:2008+A1:2013ISO 7405:2008+A1:2013 (E)BS EN ISO 7405:2008ISO 7405:2008(E) ISO 2008 All rights reserved vIntroduction This International Standard concerns the evaluation of the biocompatibilityofmedical devices usedindentistry. It is to be used in conju

31、nction with the ISO10993 series of standards. This International Standardcontains special tests, forwhich ample experience exists in dentistry and which acknowledge the specialneeds ofdentistry.Only test methods for which the members of the committee considered therewas sufficient published datahave

32、 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 fulland careful review of the evidence indicating that a similar outcome cannot be achieved

33、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 animal at the same time, e.g. pulp and dentinusage test and pulp cappin

34、g test. However,in accordance with ISO10993-2 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 procedures as describedfor each test. This International Standard doe

35、s 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 willfurther reduce the use of animals in the evaluation of the biocompatibility of medical devices used in dentistry.BS EN ISO

36、7405:2008+A1:2013ISO 7405:2008+A1:2013 (E)BS EN ISO 7405:2008BS EN ISO 7405:2008+A1:2013BS EN ISO 7405:2008INTERNATIONAL STANDARD ISO 7405:2008(E) ISO 2008 All rights reserved 1Dentistry Evaluation of biocompatibility of medical devices used in dentistry1 Scope This International Standard specifies

37、test methods for the evaluation of biological effects of medical devices used in dentistry. It includes testing of pharmacological agents that are an integral part of the device undertest. This International Standard does not cover testing ofmaterials and devices that do not come into direct orindir

38、ect contact with the patients body. 2 NormativereferencesThe following referenced documents are indispensable for the application of this document. For datedreferences, only the edition cited applies. For undated references, the latest edition of the referenceddocument (including any amendments) app

39、lies.ISO 1942, Dentistry VocabularyISO 6344-1, Coated abrasives Grain size analysis Part 1: Grain size distribution testISO 10993-1, Biological evaluation of medical devices Part1: Evaluation and testing within a riskmanagement processISO 10993-2, Biological evaluation of medical devices Part 2: Ani

40、mal welfare requirementsISO 10993-3, Biological evaluation of medical devices Part3: Tests for genotoxicity, carcinogenicity andreproductive toxicityISO 10993-5, Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicityISO 10993-6, Biological evaluation of medical devices Part

41、 6: Tests for local effects after implantationISO 10993-101), Biological evaluation of medical devices Part10: Tests for irritation and skin sensitization ISO 10993-11, Biological evaluation of medical devices P art11: Tests for systemic toxicityISO 10993-12:2007, Biological evaluation of medical de

42、vices Part12: Sample preparation and referencematerialsISO 14971, Medical devices Application of risk management to medical devices1) To be published. ISO 7405:2008+A1:2013 (E)BS EN ISO 7405:2008+A1:2013BS EN ISO 7405:2008ISO 7405:2008(E)2 ISO 2008 All rights reserved3 Terms and definitions For the

43、purposes of this document, the terms and definitions given in ISO 1942, ISO10993-1, ISO 10993-12and the following apply.3.1 medical device any instrument, apparatus, appliance, software, material or other article, whether used alone or incombination,together with any accessories, including the softw

44、are necessary for its proper application intended by the manufacturer to be used formedical purposes for human beings for the purpose of: diagnosis, prevention, monitoring, treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap

45、; investigation, replacement or modification of the anatomy or of a physiological process; c ontrol of conception; and which does not achieve its principal intended action in or on the human bodyby pharmacological,immunological or metabolic means, but which maybe assisted in its function by such mea

46、ns3.2 dental materialmaterial and/or substanceor combination of materials and/or substances specially formulated and prepared for use in the practice of dentistryand/or associated procedures3.3 final product medical devicein its “as-used” state NOTEMany dental materials are used in a freshly mixed s

47、tate, and evaluation of the materials in both freshly mixedand set conditions should be considered. 3.4 positive control positive control material anywell characterized material and/or substance that, when evaluated by a specific test method, demonstrates the suitabilityof the test system to yield a

48、 reproducible, appropriately positive or reactiveresponse in the test system3.5 negative control negative control materialanywell characterized material and/or substance that, when evaluated by a specific test method, demonstrates the suitability of the test system to yield a reproducible, appropria

49、tely negative, non-reactive orminimal response in the test systemNOTE In practice, negative controls include blanks, vehicles/solvents and reference materials. 3.6 reference material material with one or more property values that are sufficiently reproducible and well established to enable use of the material or substance for the calibration of an apparatus, the assessment of a measurement method orfor the assignment of values to materialsNOTE For the purpose of this document, a reference material is any well characteriz