BS DD ISO TS 10993-19-2006 Biological evaluation of medical devices - Physico-chemical morphological and topographical characterization of materials《医疗设备的生物评定 材料的物理-化学、形态学和地形学特征》.pdf

1、 g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58morphological and topographical characterization of materialsICS 11.100.20Biological evaluation of

2、medical devices Part 19: Physico-chemical, DRAFT FOR DEVELOPMENTDD ISO/TS 10993-19:2006DD ISO/TS 10993-19:2006This Draft for Development was published under the authority of the Standards Policy and Strategy Committee on 31 August 2006 BSI 2006ISBN 0 580 49048 3Technical Committee CH194, Biological

3、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 text.A list of organizations represented on this subcommittee can be obtained on request to

4、its secretary.Cross-referencesThe British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic

5、 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 pagesThis document comprises a front cover, an inside front cover, the ISO/TS title page, pages ii to vi, pa

6、ges 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 publicationAmd. No. Date Commentsafter its publication.Notification of the start of the review period, with a request for the submission of comments fr

7、om users of this Draft for Development, will be made in an announcement in the appropriate issue of Update Standards. 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

8、taken.Observations which it is felt should receive attention before the official call for comments will be welcomed. These should be sent to the Secretary of BSI National forewordThis Draft for Development reproduces verbatim ISO/TS 10993-19:2006.This publication is not to be regarded as a British S

9、tandard.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 this Draft for Development will be carried out no

10、t later than 2 years Reference numberISO/TS 10993-19:2006(E)TECHNICAL SPECIFICATION ISO/TS10993-19First edition2006-06-01Biological evaluation of medical devices Part 19: Physico-chemical, morphological and topographical characterization of materials valuation biologique des dispositifs mdicaux Part

11、ie 19: Caractrisations physicochimique, morphologique et topographique des matriaux DD ISO/TS 10993-19:2006ii iiiContents Page Foreword iv Introduction . vi 1 Scope 1 2 Normative references 1 3 Terms and definitions .1 4 Symbols and abbreviated terms 2 5 General principles2 6 Characterization proced

12、ure 3 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 (informative) Principles for judging material equivalency 9 Annex B (informative

13、) Nanoparticles Special consideration in judging material equivalency and biological evaluation .10 Bibliography 11 DD ISO/TS 10993-19:2006iv Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of prep

14、aring 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 organizations, governmental and non-governmental, in

15、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 the ISO/IEC Directives, Part 2. The main task

16、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 % of the member bodies casting a vote. In other c

17、ircumstances, particularly when there is an urgent market requirement for such documents, 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

18、accepted for publication if it is approved by more than 50 % of the members of the 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

19、the committee casting a vote. An ISO/PAS or ISO/TS is reviewed after three years in 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 yea

20、rs, at which time it must either be transformed into an International Standard or be 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/T

21、S 10993-19 was prepared by Technical Committee ISO/TC 194, Biological evaluation of 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 genot

22、oxicity, carcinogenicity and reproductive toxicity Part 4: Selection of tests for interactions 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

23、of potential degradation products DD ISO/TS 10993-19:2006v 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 quantification of degradation products from polymeric medica

24、l 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 and leachables Part 17: Establishment of allowable limits

25、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 ISO/TS 10993-19:2006vi Introduction ISO 14971 points ou

26、t that a toxicological risk analysis should take account of the nature of the materials. ISO 10993-1 provides 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 manu

27、facture, the first consideration should be fitness for purpose. This should have regard to the characteristics and properties of the material, which include chemical, toxicological, physical, electrical, morphological and mechanical properties. This information is necessary prior to any biological e

28、valuation. ISO 10993-1:2003, 7.2 notes that the continuing acceptability of a biological evaluation is an 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 im

29、portant in determining the biological evaluation of that device and its materials. Such information can be 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 propo

30、sed clinical application. The compositional characteristics of the materials of manufacture are mainly under 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 p

31、rocesses used by the medical device manufacturer. DD ISO/TS 10993-19:20061Biological evaluation of medical devices Part 19: Physico-chemical, morphological and topographical characterization of materials 1 Scope This Technical Specification provides a compilation of parameters and test methods that

32、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 the medical devices intended use (c

33、linical 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 and ISO 10993-15. Chemical characte

34、rization 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 referenced documents are indispensable fo

35、r 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: Evaluation and testing ISO 10993-18,

36、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 to the physical chemistry (of materi

37、als) 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 10993-19:20062 4 Symbols and abbreviated terms The following abbreviations are used throughout the document. NP: n

38、anoparticle PMT: physico-chemical, morphological and topographical The abbreviations listed in Table 1 are used in Clause 7. Table 1 Methodology abbreviations Abbreviation Analytical method AES Auger Electron Spectroscopy including scanning tunneling auger AFM/SPM Atomic Force Microscopy/Scanning Pr

39、obe Microscopy including topographical roughness and phase contrast BET Brunauer-Emmett-Teller, a porosity measurement methodology CLSM Confocal Laser Scanning Microscopy DMTA Dynamic Mechanical Thermal Analysis DSC Differential Scanning Calorimetry EPMA Electron Probe Microanalyser ESC Equilibrium

40、Solvent Content EWC Equilibrium Water Content EDX-SEM Energy Dispersive X-ray Analysis Scanning Electron Microscopy FTIR Fourier Transform Infra Red (spectroscopy) including microscopy, imaging and diffuse reflectance FTIR-ATR Fourier Transform Infra Red (spectroscopy) Attenuated Total Reflectance (

41、multiple internal reflectance)IR Infra Red (spectroscopy) OM Optical Microscopy including polarized light and phase contrast microscopy QCM Quartz Crystal Microbalance (or other microbalance techniques) SEM/TEM Scanning Electron Microscopy/Transmission Electron Microscopy SPR Surface Plasmon Resonan

42、ce TOF/SIMS Time of Flight Secondary Ionization Mass Spectroscopy TMA Thermal Mechanical Analyser XPS/ESCA X-ray Photoelectron Spectroscopy/ Electron Spectroscopy for Chemical Analysis 5 General principles Consideration of the PMT characterization of the materials from which a medical device is made

43、, like chemical characterization of materials (addressed in ISO 10993-18), is a necessary step in assessing the biological safety 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

44、material, or b) a prototype device to a final device. DD ISO/TS 10993-19:20063The 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 relationships are be

45、coming 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 scaffold

46、s and meshes, with certain PMT characteristics, as implants into injured soft or hard tissue can facilitate the beneficial infiltration of certain types of cells which aid the healing process (Dexter et al. 50). 3) The PMT characteristics of the surfaces of materials used as catheters have a major i

47、nfluence on the adherence of bacteria and proteins to the inner and outer surfaces, which in turn influences the risk of infections and blockages. 4) Alterations to the micro-topography of surfaces, e.g. producing microgrooves or other defined patterns, has been shown to influence the adhesion and d

48、irection of movement of certain types of cells on that surface (Alaerts et al. 46; Dewez et al. 49). 5) For certain medical devices e.g. orthopaedic implants and vascular prostheses, mechanical properties may influence biological responses such as tissue re-modelling. NOTE The shape and geometric fo

49、rm of medical devices and their components are known to affect the biological response, e.g. aspect ratio, thickness, form with relation to blood flow. Information on specific devices may be found in the applicable product standards. This technical specification provides a range of examples of PMT characterization parameters and methods which may be usefully applied in the PMT characterization of materials utilized in medical devices. Medical device manufacturers should select r