DIN EN ISO 22794-2009 Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file (ISO 22794 2007 corrected.pdf

1、November 2009DEUTSCHE NORM English price group 11No part of this standard 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).ICS 11.060.15!$Zo*“155760

2、7www.din.deDDIN EN ISO 22794Dentistry Implantable materials for bone filling and augmentation in oral andmaxillofacial surgery Contents of a technical file (ISO 22794:2007, correctedversion 2009-01-15)English version of DIN EN ISO 22794:2009-11Zahnheilkunde Implantierbare Materialien zum Auffllen vo

3、n Knochendefekten und zur Augmentation beioralen und maxillofazialen Eingriffen Inhalt der Technischen Dokumentation (ISO 22794:2007, korrigierte Fassung 2009-01-15)Englische Fassung DIN EN ISO 22794:2009-11SupersedesDIN EN ISO 22794:2007-10www.beuth.deDocument comprises 18 pagesDIN EN ISO 22794:200

4、9-11 2 National foreword This standard 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 German body involved in its preparation was the Normenausschu

5、ss Dental (Dentistry Standards Committee), Technical Committee NA 014-00-21 AA Dentalimplantate. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 1942 E DIN EN ISO 1942 ISO 10993-1 DIN EN ISO 10993-1 ISO 10993-17 DIN EN ISO 10993-17 ISO

6、11135-1 DIN EN ISO 11135-1 ISO 11137-1 DIN EN ISO 11137-1 ISO 11607-2 DIN EN ISO 11607-2 ISO 14155-1 DIN EN ISO 14155-1 ISO 14155-2 DIN EN ISO 14155-2 ISO 14937 DIN EN ISO 14937 ISO 14971 DIN EN ISO 14971 ISO 15223 DIN EN 980 ISO 17665-1 DIN EN ISO 17665-1 Amendments This standard differs from DIN E

7、N ISO 22794:2007-10 as follows: a) The corrected version 2009-01-15 of ISO 22794 has been adopted. b) Normative references and the bibliography have been updated and the cross references in subclauses 5.2, 5.5.5, 5.7, 5.8 and 5.9.2 have been changed accordingly. c) Subclauses 5.5.3 and 5.5.4 have be

8、en added, subclause 5.5.3 is now subclause 5.5.5. Previous editions DIN EN ISO 22794: 2007-10 DIN EN ISO 22794:2009-11 3 National Annex NA (informative) Bibliography DIN EN 980, Graphical symbols for use in the labelling of medical devices E DIN EN ISO 1942, Dentistry Terminology DIN EN ISO 10993-1,

9、 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management system DIN EN ISO 10993-17, Biological evaluation of medical devices Part 17: Establishment of allowable limits for leachable substances DIN EN ISO 11135-1, Sterilization of health care products Ethylen

10、e oxide Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices DIN EN ISO 11137-1, Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medi

11、cal devices DIN EN ISO 11607-1, Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems DIN EN ISO 14155-1, Clinical investigation of medical devices for human subjects Part 1: General requirements DIN EN ISO 14155-2, Clin

12、ical investigation of medical devices for human subjects Part 2: Clinical investigation plans DIN EN ISO 14937, Sterilization of health care products General criteria for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medica

13、l devices DIN EN ISO 14971, Medical devices Application of risk management to medical devices DIN EN ISO 17665-1, Sterilization of health care products Moist heat Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices DIN EN ISO 22794:

14、2009-11 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 22794 August 2009 ICS 11.060.15 Supersedes EN ISO 22794:2007English Version Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a techni

15、cal file (ISO 22794:2007, corrected version 2009-01-15) Art dentaire - Matriaux implantables de comblement et de reconstruction osseuse en chirurgie orale et maxillofaciale -Contenu dun dossier technique (ISO 22794:2007, version corrige 2009-01-15) Zahnheilkunde - Implantierbare Materialien zum Auff

16、llen von Knochendefekten und zur Augmentation bei oralen und maxillofazialen Eingriffen - Inhalt der Technischen Dokumentation (ISO 22794:2007, korrigierte Fasung 2009-01-15) This European Standard was approved by CEN on 3 August 2009. CEN members are bound to comply with the CEN/CENELEC Internal Re

17、gulations which stipulate the conditions for giving this European Standard 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 Management Centre or to any CEN member. Th

18、is European Standard exists in three official versions (English, 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 Management Centre has the same status as the official versions. CEN members are

19、 the national standards bodies of Austria, 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, Switzer

20、land and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN

21、 ISO 22794:2009: EContents 2 EN ISO 22794:2009 (E) DIN EN ISO 22794:2009-11 Page Foreword .3 Introduction.4 1 Scope5 2 Normative references5 3 Terms and definitions .6 4 Implantable materials7 5 Technical file7 5.1 Contents .7 5.2 Chemical composition 7 5.3 Physical properties .8 5.4 Intended applic

22、ations, precautions, warnings and instructions8 5.5 Preclinical and clinical evaluation.9 5.6 Manufacture .10 5.7 Materials of animal origin .10 5.8 Sterilization 10 5.9 Packaging.11 5.10 Additional information supplied by the manufacturer 11 Bibliography13 3 Foreword The text of ISO 22794:2007, cor

23、rected version 2009-01-15 has been prepared by Technical Committee ISO/TC 106 “Dentistry” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 22794:2009 by Technical Committee CEN/TC 55 “Dentistry” the secretariat of which is held by DIN. This European Stand

24、ard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by January 2010, and conflicting national standards shall be withdrawn at the latest by January 2010. Attention is drawn to the possibility that some of the elements of t

25、his 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 22794:2007. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following count

26、ries 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, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spai

27、n, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 22794:2007, corrected version 2009-01-15 has been approved by CEN as a EN ISO 22794:2009 without any modification. DIN EN ISO 22794:2009-11 EN ISO 22794:2009 (E) Introduction Different materials used for the preservati

28、on of masticatory function, such as dental restorative materials and dental implants are subject to standards and regulations, either in existence or in preparation, designed to evaluate the performance of these products. Implantable materials for bone filling and augmentation in oral and maxillofac

29、ial surgery are not covered by the procedures for evaluating and testing dental restorative materials and dental implants; it is necessary to develop a new standard for these materials. The aim of this International Standard is to define the content of a technical file that demonstrates safety and e

30、ffectiveness of bone filling and augmentation materials used in oral and maxillofacial surgery. 4 EN ISO 22794:2009 (E) DIN EN ISO 22794:2009-11 1 Scope This International Standard applies to implantable materials, whether resorbable or non-resorbable, used as dental devices for filling and augmenti

31、ng bones in oral and maxillofacial surgery. Products that are essentially pure ( 90 %) hydroxyapatite are not covered by this International Standard. Evaluation includes the physico-chemical, mechanical, biological and clinical aspects and behaviour of these implantable dental materials. Materials s

32、uch as autografts, allografts and membranes, and products for which the primary intended use is to deliver a medicinal product, are not covered by this International Standard. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated

33、references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 1942 1), Dentistry Vocabulary ISO 10993-1 2), Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management sys

34、tem ISO 10993-17, Biological evaluation of medical devices Part 17: Establishment of allowable limits for leachable substances ISO 11135-1 3), Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medi

35、cal devices ISO 11137-1 4), Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices ISO 11607-2 5), Packaging for terminally sterilized medical devices Part 2: Validation requirements for form

36、ing, sealing and assembly processes 1) To be published. (Revises and replaces ISO 1942 parts 1 to 5:1989) 2) To be published. (Revision of ISO 10993-1:2003) 3) Cancels and replaces ISO 11135:1994 and ISO 11135:1994/Cor.1:1994. 4) Cancels and replaces ISO 11137:1995, ISO 11137:1995/Cor.1:1997 and ISO

37、 11137:1995/Amd.1:2001. 5) Cancels and replaces ISO 11607:2003. 5 DIN EN ISO 22794:2009-11 EN ISO 22794:2009 (E) ISO 13408-1, Aseptic processing of health care products Part 1: General requirements ISO 14155-1 6), Clinical investigation of medical devices for human subjects Part 1: General requireme

38、nts ISO 14155-2 6), Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans ISO 14937, Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilizati

39、on process for medical devices ISO 14971, Medical devices Application of risk management to medical devices ISO 15223, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied ISO 17665-1 7), Sterilization of health care products Moist heat Part 1: Requ

40、irements for the development, validation and routine control of a sterilization process for medical devices EN 1041, Information supplied by the manufacturer of medical devices 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 1942 and the following ap

41、ply. 3.1 biocompatibility a) capability of a material to fulfil its function with an appropriate response for a specific application from the receiving host; b) quality of being accepted in a specific living environment without adverse or unwanted side effects 3.2 biomaterial a) material intended to

42、 interface with the biological system to evaluate, treat, augment or replace tissue, organ or function of the organism; b) material specially prepared and/or presented to exhibit bioacceptability, biocompatibility or positive biocompatiblity NOTE The implantable materials referred to in this documen

43、t are all biomaterials. 3.3 filling surgical placement of a biomaterial, resorbable or non-resorbable, into an intrabony cavity during oral and maxillofacial surgery NOTE Intrabony cavity includes extraction socket. 3.4 augmentation surgical placement of a biomaterial, resorbable or non-resorbable,

44、to increase the volume of bone, usually on the sinus floor or the alveolar ridges 6) Cancels and replaces ISO 14155:1996. 7) Cancels and replaces ISO 11134:1994 and ISO 13683:1997. 6 EN ISO 22794:2009 (E) DIN EN ISO 22794:2009-11 3.5 resorption progressive elimination by cellular activity and/or dis

45、solution of a material in a biological environment 3.6 medicinal product substance that produces its intended effect by pharmaceutical means 4 Implantable materials The development of implantable materials shall be considered with regard to the properties required for the intended purpose, taking in

46、to account the effects of manufacture, handling, sterilization and storage. Possible reactions (intended or not) of implantable materials with human tissues and body fluids, other materials, other implants, substances, gases, radiation and electromagnetic fields shall be considered. Implantable mate

47、rials for bone reconstruction in oral and maxillofacial surgery are used either for filling or augmentation. 5 Technical file 5.1 Contents The contents of a technical file shall include at least the following: details of the chemical composition and physical properties of the implantable material; i

48、ts intended performance; its preclinical and clinical evaluation; details of its manufacture, sterilization and packaging; all information necessary for the user (as detailed later). New materials, for which the following characterization methods may not be adequate, shall be characterized using tec

49、hniques appropriate to the materials and the choice of technique shall be justified. 5.2 Chemical composition As appropriate, the following shall apply. The complete chemical composition, summing to 100 % by mass, including all additives, shall be described. The crystalline and non-crystalline phases, phase purity, and the mass fractions of phases, using X-ray diffraction (XRD), Fourier transform infrared spectroscopy (FTIR) and/or differential scanning calorimetry (DSC), as appropriat