BS 7254-2-1990 Orthopaedic implants - Specification for general requirements for materials and finish《矫形外科植入物 第2部分 材料和精加工一般要求规范》.pdf
《BS 7254-2-1990 Orthopaedic implants - Specification for general requirements for materials and finish《矫形外科植入物 第2部分 材料和精加工一般要求规范》.pdf》由会员分享,可在线阅读,更多相关《BS 7254-2-1990 Orthopaedic implants - Specification for general requirements for materials and finish《矫形外科植入物 第2部分 材料和精加工一般要求规范》.pdf(8页珍藏版)》请在麦多课文档分享上搜索。
1、BRITISH STANDARD BS7254-2: 1990 Orthopaedic implants Part2: Specification for general requirements for materials and finishBS7254-2:1990 This British Standard, having been prepared under the directionof the Health Care Standards Policy Committee, waspublished under the authorityof the Board of BSI a
2、ndcomes into effect on 30April1990 BSI09-1999 The following BSI references relate to the work on this standard: Committee reference HCC/22 Draft for comment88/55737 DC ISBN 0 580 18099 9 Committees responsible for this British Standard The preparation of this British Standard was entrusted by the He
3、alth Care Standards Policy Committee (HCC/-) to Technical Committee HCC/22, upon which the following bodies were represented: British Institute of Surgical Technologists British Investment Casting Trade Association British Medical Association British Orthopaedic Association British Steel Industry Br
4、itish Surgical Trades Association Incorporated Department of Health Institute of Sterile Services Management Medical Sterile Products Association Ministry of Defence National Association of Theatre Nurses Royal College of Surgeons of England Royal Veterinary College Scottish Office Coopted members A
5、mendments issued since publication Amd. No. Date of issue CommentsBS7254-2:1990 BSI 09-1999 i Contents Page Committees responsible Inside front cover Foreword ii 1 Scope 1 2 Orthopaedic implants made of wrought stainless steel 1 3 Orthopaedic implants made of cast cobalt-based alloy 1 4 Orthopaedic
6、implants made of wrought cobalt-based alloy 1 5 Orthopaedic implants made of wrought titanium 1 6 Orthopaedic implants made of wrought titanium alloy 2 7 Orthopaedic implants made of non-metallic materials 2 Table 1 Nomenclature of titanium and titanium alloy 2 Publications referred to Inside back c
7、overBS7254-2:1990 ii BSI 09-1999 Foreword This Part of BS7254 has been prepared under the direction of the Health Care Standards Policy Committee and, together with BS7254-1, supersedes BS3531-1:1980 which is withdrawn. Requirements for orthopaedic implants (then termed “surgical implants”) were fir
8、st published in1962 as BS3531. In1968 a part revision of BS3531:1962 was issued as BS3531-1, which dealt with surgical implants made of all materials. In1980 the first four Parts of a multi-part revision of BS3531 were published, Part1:1980 comprising requirements for general aspects and for marking
9、 and packaging of surgical implants. Between1980 and1988 a further19 Parts of BS3531 were published specifying materials, design and performance, and giving guidance on different types of surgical implants. In view of the growth of the number of Parts, and with a view to facilitating the implementat
10、ion of published and forthcoming ISO implant standards, BS3531 is being restructured. Accordingly, the number BS3531 will be reserved for standards for implants for osteosynthesis, BS7251 will cover joint prostheses, BS7252 will cover metallic materials for surgical implants, BS7253 will cover non-m
11、etallic materials for surgical implants and BS7254 will cover orthopaedic implants, i.e.aspects common to both osteosynthesis and joint replacement. Requirements for marking and packaging of orthopaedic implants are published as BS7254-1. The materials specified are those which are the most suitable
12、 in the light of present knowledge to provide optimum mechanical properties in relation to requirements for corrosion resistance and physiological compatibility with living tissues. All metals will corrode or erode in the body to a greater or lesser extent depending on the local conditions. In deter
13、mining the choice of material to be used in any particular case, due regard should be paid to its mechanical properties, e.g.wrought titanium is unsuitable for load bearing surfaces that involve movement of metal on metal. Orthopaedic implants should not be used again after removal from the patient.
14、 It is strongly recommended that the products specified in this Part of BS7254 should be manufactured according to the recommendations given in the “Guide to Good Manufacturing Practice for Orthopaedic Implants” 1) . Product certification. Users of this British Standard are advised to consider the d
15、esirability of third party certification of product conformity with this British Standard based on testing and continued surveillance, which may be coupled with assessment of a suppliers quality systems against the appropriate Part of BS5750. Enquiries as to the availability of third party certifica
16、tion schemes will be forwarded by BSI to the Association of Certification Bodies. If a third party certification scheme does not already exist, users should consider approaching an appropriate body from the list of Association members. A British Standard does not purport to include all the necessary
17、 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. Summary of pages This document comprises a front cover, an inside front cover, pagesi andii, pages1 and 2
18、, 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. 1) Compiled by the Department of Health and Social Security; published and available from He
19、rMajestys Stationery Office. ISBN0113208464.BS7254-2:1990 BSI 09-1999 1 1 Scope This Part of BS7254 specifies general requirements for materials and finish of orthopaedic implants used for bone surgery including osteosynthesis and joint replacement, and made of wrought austenitic stainless steel, ca
20、st cobalt-based alloys, wrought cobalt-based alloys, wrought titanium, wrought titanium alloy and non-metallic materials. NOTE 1This Part of BS7254 gives requirements for implants for osteosynthesis and for partial and total joint prostheses. These requirements may be referred to in, or superseded b
21、y, Parts of BS3531 and BS7251 as regards particular types of orthopaedic implant. However, it is unlikely that every type of orthopaedic implant will be covered by a Part of BS3531 or BS7251 and, if no individual product specification exists, this Part of BS7254 is intended to give requirements appl
22、icable to orthopaedic implants in general. NOTE 2The titles of the publications referred to in this standard are listed on the inside back cover. 2 Orthopaedic implants made of wrought stainless steel 2.1 Material and fabrication Orthopaedic implants or components of implants shall be machined or fo
23、rged from wrought austenitic stainless steel complying with BS7252-1 or BS7252-9. The implant shall not be made from castings and welding methods shall not be employed. 2.2 Finish The surfaces of implants made of stainless steel shall be free from draw marks, pits, burrs and surface contamination. U
24、nless contra-indicated by requirements for the surface finish and geometry of the product, all surfaces of the implant shall be mechanically polished and/or electro-polished followed by degreasing, cleaning and a final passivation process. Mechanical polishing shall be undertaken with an iron-free a
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