BS-ISO-13779-1-2000.pdf
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1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS ISO 13779-1:2000 ICS 1
2、1.040.40 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Implants for surgery Hydroxyapatite Part 1: Ceramic hydroxyapatite Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:51:53 GMT+00:00 2006, Uncontrolled Copy, (c) BSI This British Standard, having been prepared un
3、der the direction of the Health and Environment Sector Committee, was published under the authority of the Standards Committee and comes into effect on 15 November 2000 BSI 11-2000 ISBN 0 580 36466 6 BS ISO 13779-1:2000 Amendments issued since publication Amd. No.DateComments National foreword This
4、British Standard reproduces verbatim ISO 13779-1:2000 and implements it as the UK national standard. The UK participation in its preparation was entrusted to Technical Committee CH/18, Surgical implant materials, which has the responsibility to: aid enquirers to understand the text; present to the r
5、esponsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. A list of organizations represented on this committee can be obtained o
6、n 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 Standards Catalogue under the section entitled International Standards Correspondence Index, or by using the Find facility of
7、 the BSI Standards Electronic Catalogue. 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 with a British Standard does not of itself confer immunity from legal obligations.
8、Summary of pages This document comprises a front cover, an inside front cover, the ISO title page, pages ii to iv, pages 1 to 3 and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02
9、:51:53 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Reference number ISO 13779-1:2000(E) INTERNATIONAL STANDARD ISO 13779-1 First edition 2000-08-01 Implants for surgery Hydroxyapatite Part 1: Ceramic hydroxyapatite Implants chirurgicaux Hydroxyapatite Partie 1 :Cramique base dhydroxyapatite Licensed
10、Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:51:53 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ISO 13779-1:2000(E) ii Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:51:53 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ISO 13779-1:2000(E) iii Foreword ISO (the International Organization for
11、 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 committees. Each member body interested in a subject for which a technical committee has been established has the
12、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 International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. Internatio
13、nal Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3. 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
14、bodies casting a vote. Attention is drawn to the possibility that some of the elements of this part of ISO 13779 may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. International Standard ISO 13779-1 was prepared by Technical Committe
15、e ISO/TC 150, Implants for surgery, Subcommittee SC 1, Materials. ISO 13779 consists of the following parts, under the general title Implants for surgery Hydroxyapatite: ?Part 1: Ceramic hydroxyapatite ?Part 2: Coatings of hydroxyapatite ?Part 3: Chemical analysis and characterization of crystallini
16、ty and phase purity ?Part 4: Determination of coating adhesion strength Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:51:53 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ISO 13779-1:2000(E) iv Introduction No known surgical implant material has ever been shown to cause absolutely no adverse
17、 reactions in the human body. However, long-term clinical experience of the use of the material referred to in this part of ISO 13779 has shown that an acceptable level of biological response can be expected, if the material is used in appropriate applications. The biological response to hydroxyapat
18、ite ceramic has been demonstrated by a history of clinical use and by laboratory studies. See Bibliography. Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:51:53 GMT+00:00 2006, Uncontrolled Copy, (c) BSI INTERNATIONAL STANDARD ISO 13779-1:2000(E) 1 Implants for surgery Hydroxyapatite Part
19、 1: Ceramic hydroxyapatite 1 Scope This part of ISO 13779 specifies requirements for ceramic hydroxyapatite intended for use as surgical implants. This part of ISO 13779 does not apply to hydroxyapatite coatings, non-ceramic hydroxyapatite, hydroxyapatite powder, glass ceramics, ?- and ?-tricalcium
20、orthophosphate or other forms of calcium phosphate. 2 Normative references The following normative documents contain provisions which, through reference in this text, constitute provisions of this part of ISO 13779. For dated references, subsequent amendments to, or revisions of, any of these public
21、ations do not apply. However, parties to agreements based on this part of ISO 13779 are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies.
22、 Members of ISO and IEC maintain registers of currently valid International Standards. ISO 10993-17:1?, Biological evaluation of medical devices Part 17: Establishment of allowable limits for leachable substances using health-based risk assessment. ISO 13779-3:1?, Implants for surgery Hydroxyapatite
23、 Part 3: Chemical analysis and characterization of crystallinity and phase purity. 3 Terms and definitions For the purposes of this part of ISO 13779, the following terms and definitions apply. 3.1 ceramic hydroxyapatite hydroxyapatite which has been sintered into a coherent crystalline mass by subj
24、ecting it to conditions at which the crystals in the powder fuse together 3.2 hydroxyapatite chemical compound with a crystallographic structure characterized by the powder diffraction file PDF 9-432 of the International Committee for Diffraction Data ICDD, USA NOTE The chemical formula is Ca5(OH)(P
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