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1、DRAFT FOR DEVELOPMENT DD ISO/TS 10993-19:2006 Biological evaluation of medical devices Part 19: Physico-chemical, morphological and topographical characterization of materials ICS 11.100.20 ? Licensed Copy: London South Bank University, London South Bank University, Sun Dec 10 13:30:56 GMT+00:00 200
2、6, Uncontrolled Copy, (c) BSI DD ISO/TS 10993-19:2006 This Draft for Development was published under the authority of the Standards Policy and Strategy Committee on 31 August 2006 BSI 2006 ISBN 0 580 49048 3 National foreword This Draft for Development reproduces verbatim ISO/TS 10993-19:2006. This
3、publication is not to be regarded as a British Standard. It is being issued in the Draft for Development series of publications and is of a provisional nature. It should be applied on this provisional basis, so that information and experience of its practical application may be obtained. A review of
4、 this Draft for Development will be carried out not later than 2 years after its publication. Notification of the start of the review period, with a request for the submission of comments from users of this Draft for Development, will be made in an announcement in the appropriate issue of Update Sta
5、ndards. According to the replies received, the responsible BSI Committee will judge whether the Draft for Development can be converted into a British Standard or what other action should be taken. Observations which it is felt should receive attention before the official call for comments will be we
6、lcomed. These should be sent to the Secretary of BSI Technical Committee CH194, Biological evaluation of medical devices, at British Standards House, 389 Chiswick High Road, London W4 4AL, giving the document reference and clause number and proposing, where possible, an appropriate revision of the t
7、ext. A list of organizations represented on this subcommittee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “Internat
8、ional Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Summary of pages This d
9、ocument comprises a front cover, an inside front cover, the ISO/TS title page, pages ii to vi, pages 1 to 15 and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. DateComments Licensed Copy: Lon
10、don South Bank University, London South Bank University, Sun Dec 10 13:30:56 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Reference number ISO/TS 10993-19:2006(E) TECHNICAL SPECIFICATION ISO/TS 10993-19 First edition 2006-06-01 Biological evaluation of medical devices Part 19: Physico-chemical, morpho
11、logical and topographical characterization of materials valuation biologique des dispositifs mdicaux Partie 19: Caractrisations physicochimique, morphologique et topographique des matriaux DD ISO/TS 10993-19:2006 Licensed Copy: London South Bank University, London South Bank University, Sun Dec 10 1
12、3:30:56 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii Licensed Copy: London South Bank University, London South Bank University, Sun Dec 10 13:30:56 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iii Contents Page Foreword iv Introduction. vi 1 Scope 1 2 Normative references1 3 Terms and definitions .1
13、4 Symbols and abbreviated terms 2 5 General principles2 6 Characterization procedure3 6.1 General3 6.2 Qualitative information4 6.3 Material equivalence4 6.4 Quantitative information .4 6.5 Quantitative assessment 4 7 Characterization parameters and methods.5 8 Reporting of data obtained.8 Annex A (
14、informative) Principles for judging material equivalency 9 Annex B (informative) Nanoparticles Special consideration in judging material equivalency and biological evaluation .10 Bibliography11 DD ISO/TS 10993-19:2006 Licensed Copy: London South Bank University, London South Bank University, Sun Dec
15、 10 13:30:56 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iv Foreword 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 committ
16、ees. 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 organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the Int
17、ernational Electrotechnical Commission (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
18、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 the member bodies casting a vote. In other circumstances, particularly when there is an urgent market requirement for such docu
19、ments, a technical committee may decide to publish other types of normative document: an ISO Publicly Available Specification (ISO/PAS) represents an agreement between technical experts in an ISO working group and is accepted for publication if it is approved by more than 50 % of the members of the
20、parent committee casting a vote; an ISO Technical Specification (ISO/TS) represents an agreement between the members of a technical committee and is accepted for publication if it is approved by 2/3 of the members of the committee casting a vote. An ISO/PAS or ISO/TS is reviewed after three years in
21、 order to decide whether it will be confirmed for a further three years, revised to become an International Standard, or withdrawn. If the ISO/PAS or ISO/TS is confirmed, it is reviewed again after a further three years, at which time it must either be transformed into an International Standard or b
22、e withdrawn. 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/TS 10993-19 was prepared by Technical Committee ISO/TC 194, Biological evaluation of
23、 medical devices. 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 i
24、nteractions with blood Part 5: Tests for in vitro cytotoxicity Part 6: Tests for local effects after implantation Part 7: Ethylene oxide sterilization residuals Part 9: Framework for identification and quantification of potential degradation products DD ISO/TS 10993-19:2006 Licensed Copy: London Sou
25、th Bank University, London South Bank University, Sun Dec 10 13:30:56 GMT+00:00 2006, Uncontrolled Copy, (c) BSI v Part 10: Tests for irritation and delayed-type hypersensitivity Part 11: Tests for systemic toxicity Part 12: Sample preparation and reference materials Part 13: Identification and quan
26、tification of degradation products from polymeric medical devices Part 14: Identification and quantification of degradation products from ceramics Part 15: Identification and quantification of degradation products from metals and alloys Part 16: Toxicokinetic study design for degradation products an
27、d leachables Part 17: Establishment of allowable limits for leachable substances Part 18: Chemical characterization of materials Part 19: Physico-chemical, morphological and topographical characterization of materials Part 20: Principles and methods for immunotoxicology testing of medical devices DD
28、 ISO/TS 10993-19:2006 Licensed Copy: London South Bank University, London South Bank University, Sun Dec 10 13:30:56 GMT+00:00 2006, Uncontrolled Copy, (c) BSI vi Introduction ISO 14971 points out that a toxicological risk analysis should take account of the nature of the materials. ISO 10993-1 prov
29、ides a framework for a structured programme of assessment for the evaluation of biological safety. ISO 10993-1:2003, Clause 3, states that in the selection of materials to be used for device manufacture, the first consideration should be fitness for purpose. This should have regard to the characteri
30、stics and properties of the material, which include chemical, toxicological, physical, electrical, morphological and mechanical properties. This information is necessary prior to any biological evaluation. ISO 10993-1:2003, 7.2 notes that the continuing acceptability of a biological evaluation is an
31、 aspect of a quality management system. The identification and evaluation of the physico-chemical, morphological and topographical properties of materials used in a finished medical device are important in determining the biological evaluation of that device and its materials. Such information can b
32、e used in: a) assessing the overall biological evaluation of a medical device (ISO 10993); b) screening of potential new materials and/or processes for suitability in a medical device for a proposed clinical application. The compositional characteristics of the materials of manufacture are mainly un
33、der the control of the suppliers of these materials. However, other characteristics are chiefly influenced by the requirements to be met by the finished medical device as well as the production processes used by the medical device manufacturer. DD ISO/TS 10993-19:2006 Licensed Copy: London South Ban
34、k University, London South Bank University, Sun Dec 10 13:30:56 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 1 Biological evaluation of medical devices Part 19: Physico-chemical, morphological and topographical characterization of materials 1 Scope This Technical Specification provides a compilation o
35、f parameters and test methods that can be useful for the identification and evaluation of the physico-chemical, morphological and topographical (PMT) properties of materials in finished medical devices. Such an assessment is limited to those properties that are relevant to biological evaluation and
36、the medical devices intended use (clinical application and duration of use) even if such properties overlap with clinical effectiveness. This part of ISO 10993 does not address the identification or quantification of degradation products, which are covered in ISO 10993-9, ISO 10993-13, ISO 10993-14
37、and ISO 10993-15. Chemical characterization of materials is covered by ISO 10993-18. The ISO 10993 series of International Standards is not applicable when the material or device does not contact the body directly or indirectly (see ISO 10993-1:2003, 4.2). 2 Normative references The following refere
38、nced 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 10993-1:2003, Biological evaluation of medical devices Part 1: Ev
39、aluation and testing ISO 10993-18, Biological evaluation of medical devices Part 18: Chemical characterization of materials 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 10993-1, ISO 10993-18 and the following apply. 3.1 physico-chemical relating t
40、o the physical chemistry (of materials) 3.2 morphological relating to the shape, contours and microstructural organization (of materials) 3.3 topographical relating to the features of the surface (of materials) DD ISO/TS 10993-19:2006 Licensed Copy: London South Bank University, London South Bank Un
41、iversity, Sun Dec 10 13:30:56 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 2 4 Symbols and abbreviated terms The following abbreviations are used throughout the document. NP: nanoparticle PMT: physico-chemical, morphological and topographical The abbreviations listed in Table 1 are used in Clause 7. T
42、able 1 Methodology abbreviations Abbreviation Analytical method AES Auger Electron Spectroscopy including scanning tunneling auger AFM/SPM Atomic Force Microscopy/Scanning Probe Microscopy including topographical roughness and phase contrast BET Brunauer-Emmett-Teller, a porosity measurement methodo
43、logy CLSM Confocal Laser Scanning Microscopy DMTA Dynamic Mechanical Thermal Analysis DSC Differential Scanning Calorimetry EPMA Electron Probe Microanalyser ESC Equilibrium Solvent Content EWC Equilibrium Water Content EDX-SEM Energy Dispersive X-ray Analysis Scanning Electron Microscopy FTIR Fouri
44、er Transform Infra Red (spectroscopy) including microscopy, imaging and diffuse reflectance FTIR-ATR Fourier Transform Infra Red (spectroscopy) Attenuated Total Reflectance (multiple internal reflectance) IR Infra Red (spectroscopy) OM Optical Microscopy including polarized light and phase contrast
45、microscopy QCM Quartz Crystal Microbalance (or other microbalance techniques) SEM/TEM Scanning Electron Microscopy/Transmission Electron Microscopy SPR Surface Plasmon Resonance TOF/SIMS Time of Flight Secondary Ionization Mass Spectroscopy TMA Thermal Mechanical Analyser XPS/ESCA X-ray Photoelectro
46、n Spectroscopy/ Electron Spectroscopy for Chemical Analysis 5 General principles Consideration of the PMT characterization of the materials from which a medical device is made, like chemical characterization of materials (addressed in ISO 10993-18), is a necessary step in assessing the biological sa
47、fety and clinical effectiveness of the device. Both types of characterization are also important in judging equivalence of: a) a proposed material to a clinically established material, or b) a prototype device to a final device. DD ISO/TS 10993-19:2006 Licensed Copy: London South Bank University, Lo
48、ndon South Bank University, Sun Dec 10 13:30:56 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 3 The relationship of PMT characteristics of materials used in devices, to their biocompatibility and clinical effectiveness, is still a developing area. However there are several examples of where these relat
49、ionships are becoming better understood, as listed below. 1) The use of certain PMT characteristics of porous materials as surfaces on orthopaedic implants can encourage tissue in-growth at the surface of the implant and thus result in better integration with the surrounding tissue. 2) The use of material scaffolds and meshes, with certain PMT characteristics, as implants into injured soft or hard tissue can facilitate the beneficial infiltration