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1、BRITISH STANDARD BS EN ISO 10993-12:1997 Biological evaluation of medical devices Part 12: Sample preparation and reference materials The European Standard EN ISO 10993-12:1996 has the status of a British Standard ICS 11.100 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 11:25:09 GMT+00:00 2
2、006, Uncontrolled Copy, (c) BSI BS EN ISO 10993-12:1997 This British Standard, having been prepared under the direction of the Health and Environment Sector Board, was published under the authority of the Standards Board and comes into effect on 15 February 1997 BSI 11-1998 The following BSI referen
3、ces relate to the work on this standard: Committee reference CH/26 Draft for comment 94/504568 DC ISBN 0 580 27017 3 Committees responsible for this British Standard The preparation of this British Standard was entrusted to Technical Committee CH/26, Biological testing of medical and dental material
4、s and devices, upon which the following bodies were represented: Association of British Health-care Industries Association of Clinical Pathologists Association of Contact Lens Manufacturers British Medical Association British Orthopaedic Association British Society for Dental Research Department of
5、Health Electro Medical Trade Association Limited Home Office Institution of Physics and Engineering in Medicine and Biology Laboratory of the Government Chemist Medical Sterile Products Association National Blood Authority Royal College of Pathologists Royal College of Surgeons of England Society fo
6、r Tissue Viability Sterilised Suture Manufacturers Association Surgical Dressings Manufacturers Association Amendments issued since publication Amd. No.DateComments Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 11:25:09 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 10993-12:1997 BSI
7、11-1998i Contents Page Committees responsibleInside front cover National forewordii Foreword2 Text of EN ISO 10993-123 List of references Inside back cover Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 11:25:09 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 10993-12:1997 ii BSI 11-199
8、8 National foreword This Part of BS EN ISO 10993 has been prepared by Technical Committee CH/26, and is the English language version of EN ISO 10993-12:1996 Biological evaluation of medical devices Part 12: Sample preparation and reference materials, published by the European Committee for Standardi
9、zation (CEN). It is identical with ISO 10993-12:1996, published by the International Organization for Standardization (ISO). A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance
10、 with a British Standard does not of itself confer immunity from legal obligations. Cross-references Publication referred toCorresponding British Standard EN ISO 9000-1:1994 (ISO 9000-1:1994) BS EN ISO 9000-1:1994 Quality managment and quality assurance standards. Guidelines for selection and use IS
11、O 9000-3:1991BS 5750-13:1991 Quality systems. Guide to the application of BS 5750-1 to the development, supply and maintenance of software ISO 9000-4:1993BS 5750-14:1993 Quality systems. Guide to dependability programme management Summary of pages This document comprises a front cover, an inside fro
12、nt cover, pages i and ii, the EN title page, pages 2 to 10, an inside back cover and a back cover. This standard has been updated (see copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover. Licensed Copy: sheffieldun sheffie
13、ldun, na, Wed Nov 15 11:25:09 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 10993-12 September 1996 ICS 11.100 Descriptors: Medical equipment, medical devices, tests, biological tests, bioassay, test specimens, specimen preparation, reference mat
14、erials English version Biological evaluation of medical devices Part 12: Sample preparation and reference materials (ISO 10993-12:1996) Evaluation biologique des dispositifs mdicaux Partie 12: Prparation des chantillons et matriaux de rfrence (ISO 10993-12:1996) Biologische Beurteilung von Medizinpr
15、odukten Teil 12: Probenvorbereitung und Referenzmaterialien (ISO 10993-12:1996) This European Standard was approved by CEN on 1996-07-26. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a nationa
16、l standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any o
17、ther language made by translation under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland
18、, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. CEN European Committee for Standardization Comit Europen de Normalisation Europisches Komitee fr Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1996 Copyright reserved to CEN
19、 members Ref. No. EN ISO 10993-12:1996 E Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 11:25:09 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 10993-12:1996 2 BSI 11-1998 Foreword The text of the International Standard ISO 10993-12:1996 has been prepared by Technical Committee ISO/TC 194
20、, Biological evaluation of medical devices, in collaboration with Technical Committee CEN/TC 206, Biocompatibility of medical and dental materials and devices, the secretariat of which is held by NNI. This European Standard shall be given the status of a national standard, either by publication of a
21、n identical text or by endorsement, at the latest by March 1997, and conflicting national standards shall be withdrawn at the latest by March 1997. This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports e
22、ssential requirements of EU Directive(s). According to the CEN/CENELEC Internal Regulations, the national standard organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg,
23、 Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. NOTENormative references to International Standards are listed in annex ZA (normative). Contents Page Foreword2 Introduction 3 1Scope3 2Normative references3 3Definitions3 4Experimental controls4 5Test material select
24、ion4 6Test sample and reference material preparation5 7Preparation of extracts of test materials5 8Test report6 Annex A (informative) Experimental controls7 Annex B (informative) Guidance for test material preparation7 Annex C (informative) Guidance for extraction of samples8 Annex D (informative) B
25、ibliography9 Annex ZA (normative) Normative references to international publications with their relevant European publications10 Table 1 6 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 11:25:09 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 10993-12:1996 BSI 11-19983 Introduction This Pa
26、rt of ISO 10993 gives guidance on methods of sample preparation and on the use of reference materials for use in biological evaluation. Because of the many different biological assay systems described in ISO 10993, the individual standards should be consulted to ascertain the appropriateness of thes
27、e recommendations for a specific test system. Sample preparation methods should consider both the biological evaluation methods and the materials being evaluated. Each biological test restricts selection of solid samples and extraction solvents or conditions by its own methodology. This Part of ISO
28、10993 is based on existing national and international specifications, regulations and standards wherever possible. It is open to regular review whenever new research work is presented to improve the state of scientific knowledge. 1 Scope This part of ISO 10993 specifies requirements and gives guidan
29、ce on procedures to be followed in the preparation of samples of medical devices for testing in biological systems in accordance with one or more other parts of ISO 10993. These include: a) test material selection; b) selection of representative portions from a device; c) test sample preparation; d)
30、 the selection of reference materials to demonstrate the suitability of the test system and/or to enable relative comparison of the biological activity of the test sample; and, e) preparation of extracts. 2 Normative references The following standards contain provisions which, through reference in t
31、his text, constitute provisions of this part of ISO 10993. At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on this part of ISO 10993 are encouraged to investigate the possibility of applying the most recent edition
32、s of the standards indicated below. Members of IEC and ISO maintain registers of currently valid International Standards. ISO 9000-1:1994, Quality management and quality assurance standards Part 1: Guidelines for selection and use. ISO 9000-2:1993, Quality management and quality assurance standards
33、Part 2: Generic guidelines for the application of ISO 9001, ISO 9002 and ISO 9003. ISO 9000-3:1991, Quality management and quality assurance standards Part 3: Guidelines for the application of ISO 9001 to the development, supply and maintenance of software. ISO 9000-4:1993, Quality management and qu
34、ality assurance standards Part 4: Guide to dependability programme management. ISO Guide 25:1990, General requirements for competence of calibration and testing laboratories. ISO Guide 30:1992, Terms and definitions used in connection with reference materials. 3 Definitions For the purposes of this
35、part of ISO 10993, the definitions given in ISO Guide 30 and the following definitions apply. 3.1 blank liquid liquid treated in the same manner as that for preparing extract liquid but without test material, and used for comparison with extract liquid 3.2 extract liquid liquid resulting from the ex
36、traction of the test material 3.3 negative control material or substance which, when tested by the procedure described, demonstrates the suitability of the procedure to yield a reproducible, appropriate negative, nonreactive or background response in the test system 3.4 positive control material or
37、substance which, when tested by the procedure described, demonstrates the suitability of the procedure to yield a reproducible, appropriate positive or reactive response in the test system 3.5 reference material material or substance one or more of whose property values are sufficiently homogeneous
38、and well established to be used for the calibration of an apparatus, the assessment of a measurement method, or for assigning values to materials ISO Guide 30 NOTE 1When tested by the procedure described, the reference material demonstrates the suitability of the procedure to yield a reproducible, p
39、redictable response. The response may be negative or positive. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 11:25:09 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 10993-12:1996 4 BSI 11-1998 3.6 certified reference material reference material, accompanied by a certificate, one or more
40、of whose property values are certified by a procedure which establishes its traceability to an accurate realization of the unit in which the property values are expressed, and for which each certified value is accompanied by an uncertainty at a stated level of confidence ISO Guide 30 3.7 test materi
41、al material, device, device portion or component thereof that is sampled for biological or chemical testing 3.8 test sample extract or portion of the test material that is subjected to biological or chemical testing 4 Experimental controls 4.1 Experimental controls shall be used in biological evalua
42、tions to validate a test procedure. Depending on the biological test being used, negative and positive controls and blanks shall be used as appropriate. The same control may be applicable to different tests to allow cross-reference to established materials and test methods. Additional guidance on th
43、e selection of experimental controls is given in annex A. NOTE 2A comparable clinically accepted device may satisfy this requirement. 4.2 Reference materials used as experimental controls shall meet the established quality assurance procedures of the manufacturer and test laboratory consistent with
44、ISO Guide 25 and ISO 9000-1, ISO 9000-2, ISO 9000-3 and ISO 9000-4. Reference materials shall be identified as to source, manufacturer, type, grade and lot number, as appropriate. 4.2.1 Reference materials and certified reference materials should be in the same material class as the test sample, e.g
45、. polymer, ceramic, metal, colloid, etc. 4.2.2 Reference materials are established by individual laboratories. The extent of chemical, physical and biological characterization is determined by the individual laboratory. Commercially available articles may be used as reference materials (see note 2,
46、in 4.1). 4.2.3 Certified reference materials are selected for their high purity, critical characteristics, suitability for the intended purpose and general availability. The critical chemical, physical and biological characteristics shall be determined by collaborative testing in three or more labor
47、atories, and made available to the investigator by the distributor. 5 Test material selection 5.1 It is preferable to test medical devices in their final product form and condition; this should be the first choice whenever practical. The second choice is to test representative portions of the device
48、 (see 5.2). When neither of these is possible or practical, representative specimens of the formulated material that have been preconditioned by the same processing as the final product should be tested. 5.2 If a device cannot be tested as a whole and contains several materials, each individual mate
49、rial which can come into contact with body tissues in the final product shall be represented proportionally in the test sample, except as described in 5.3. 5.2.1 The test sample of devices with surface coatings shall include both coating material and substrate. 5.2.2 The test sample shall include a representative portion of the joint and/or seal if adhesives, radio-frequency (RF) seals, or solvent seals are used. 5.2.3 Composite materials shall be tested as finished materials. 5.2.4 Materials which cure in situ, e.g. cements, adhesives and mono
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