BS ISO 15374-1998 Implants for surgery - Requirements for production of forgings《外科用植入物 锻件制品要求》.pdf

1、BRITISH STANDARD BS ISO 15374:1998 Implants for surgery Requirements for production of forgings ICS 11.040.40BS ISO 15374:1998 This British Standard, having been prepared under the direction of the Health and Envirnment Sector Board, was published under the authority of the Standards Board and comes

2、 into effect on 15 October 1998 BSI 06-1999 ISBN 0 580 30614 3 National foreword This British Standard reproduces verbatimISO15374:1998 and implements it as the UK national standard. It supersedesBS7254-6.1:1990 which is withdrawn The UK participation in its preparation was entrusted to Technical Co

3、mmittee CH/18, Surgical impland materials, which has the responsibility to: aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related internationa

4、l and European developments and promulgate them in the UK. A list of organizations represented on this committee 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

5、 BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of 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 res

6、ponsible 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, pages i and ii, the ISO title page, pages ii to iv, pages 1 and 2 and a back cover. Thi

7、s 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. Amendments issued since publication Amd. No. Date CommentsBS ISO 15374:1998 BSI 06-1999 i Contents Page National foreword Inside front c

8、over Foreword iii Text of ISO 15374 1ii blankBS ISO 15374:1998 ii BSI 06-1999 Contents Page Foreword iii 1 Scope 1 2 Normative references 1 3 Definitions 1 4 Composition of forging stock 1 5 Process control 1 6 Mechanical testing of forgings 2 7 Microstructure 2 8 Traceability 2 9 Identification and

9、 delivery 2 Descriptors: Medical equipment, surgical implants, metallurgical products, forgings, specifications, manufacturing requirements, microstructure, traceability, tests, mechanical tests, identification methods, labels.BS ISO 15374:1998 BSI 06-1999 iii Foreword ISO (the International Organiz

10、ation 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 committees. Each member body interested in a subject for which a technical committee has been established

11、 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 International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. D

12、raft 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. International Standard ISO 15374 was prepared by Technical Committee ISO/T

13、C150, Implants for surgery, SubcommiteeSC1, Materials.iv blankBS ISO 15374:1998 BSI 06-1999 1 1 Scope This International Standard specifies requirements for the production of forgings of stainless steel, unalloyed titanium, titanium alloy or cobalt-based alloys intended to be used as semifinished pr

14、oducts in the manufacturing of surgical implants. NOTEAn International Standard giving requirements for forgings is under preparation. 2 Normative references The following standards contain provisions which, through reference in this text, constitute provisions of this International Standard. At the

15、 time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent edition of the standards indicated below. Members of IEC and ISO ma

16、intain registers of currently valid International Standards. ISO 5832-1:1997, Implants for surgery Metallic materials Part 1: Wrought stainless steel. ISO 5832-2:1996, Implants for surgery Metallic materials Part 2: Unalloyed titanium. ISO 5832-3:1996, Implants for surgery Metallic materials Part 3:

17、 Wrought titanium 6-aluminium 4-vanadium alloy. ISO 5832-5:1993, Implants for surgery Metallic materials Part 5: Wrought cobalt-chromium-tungsten-nickel alloy. ISO 5832-6:1997, Implants for surgery Metallic materials Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy. ISO 5832-7:1994, Implants

18、for surgery Metallic materials Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum iron alloy. ISO 5832-8:1997, Implants for surgery Metallic materials Part 8: Wrought cobalt-nickel-chromium-molybdenum-tungsten-iron alloy. ISO 5832-9:1992, Implants for surgery Metallic materials Part

19、 9: Wrought high nitrogen stainless steel. ISO 5832-10:1993, Implants for surgery Metallic materials Part 10: Wrought titanium 5-aluminum 2,5-iron alloy. ISO 5832-11:1994, Implants for surgery Metallic materials Part 11: Wrought titanium 6-aluminium 7-niobium alloy. ISO 5832-12:1996, Implants for su

20、rgery Metallic materials Part 12: Wrought cobalt-chromium-molybdenum alloy. ISO 6892:1984, Metallic materials Tensile testing. EN 10204:1991, Metallic products Types of inspection documents. ETTC 2:1995, Microstructural standards for alpha + beta titanium alloy bars 1) . NOTEThe above reference will

21、 be replaced by references to appropriate International Standards when the latter become available. 3 Definitions For the purposes of this International Standard, the following definitions apply. 3.1 closed-die forging metallic article formed by pressing or hammering a metal into a closed die 3.2 ba

22、tch lot forgings to the same pattern produced from material from the same heat during one production run and, if subsequent heat treatment is required, heat-treated together 3.3 open-die forging half-finished product shaped by impact or pressure, without a cutting operation 3.4 forging semifinished

23、product or implant component produced by one or more forging operations 4 Composition of forging stock Forgings shall be made from forging stock of stainless steel, unalloyed titanium, titanium alloy or cobalt-based alloys that comply with the relevant parts of ISO 5832 (seeclause2). 5 Process contr

24、ol 5.1 Temperature The heating temperature before forging shall be controlled. 1) Available commercially from Deutsche Titan GmbH, Essen, Germany and Timet UK Ltd., Birmingham, UK. This information is given for the convenience of users of ISO 15374, and does not constitute an endorsement by ISO of t

25、hese products. These microstructural standards have been prepared by the Technical Committee for European Titanium Products.BS ISO 15374:1998 2 BSI 06-1999 For unalloyed titanium and titanium alloys, heating of the forging shall be carried out in such a manner as to minimize pick-up of hydrogen. 5.2

26、 Shear banding If shear bands are present in the material, they shall not impair the application of the product. 5.3 Surface 5.3.1 General All products produced by hot forgings shall be descaled by suitable techniques and pickled if necessary. 5.3.2 Forgings made of unalloyed titanium or of titanium

27、 alloy All oxide scale and oxygen-enriched material, including ! case, shall be removed from the surface of unalloyed titanium and titanium alloy forgings. 5.4 Hydrogen content of forgings made of unalloyed titanium or of titanium alloy When determined upon a cross-section taken from the smallest cr

28、oss-sectional area of the forging, the hydrogen content shall not exceed0,015% (mass fraction). 5.5 Heat treatment Any heat treatment after the forging operation shall be agreed between the supplier of the forgings and the customer. NOTETo achieve specific properties in the finished product, alterna

29、tive conditions may be specified such as hot-forging, warm-working or cold-forging. 6 Mechanical testing of forgings Tensile test pieces shall be prepared and tested in accordance withISO6892. For annealed forgings, the tensile properties shall comply with the relevant part ofISO5832. 7 Microstructu

30、re 7.1 General When sectioned and the microstructure examined, the forging shall be free from evidence of underheating, overheating and harmful segregation. The surface shall be free of defects detrimental to the application of the finished product. 7.2 Grain size 7.2.1 Forgings made of stainless st

31、eel After forging, the structure of the material shall comply with the requirements of the relevant part ofISO5832. 7.2.2 Forgings made of unalloyed titanium When determined in accordance with ASTM E112, the grain size shall be uniform and not larger than standard grain size5. 7.2.3 Forgings made of

32、 titanium alloy When determined in accordance with ETTC Publication 2, the microstructure shall comply with the acceptance limits given in that part ofISO5832 corresponding to the type of titanium alloy. 8 Traceability Batch traceability (see 3.2) shall be maintained throughout manufacture and deliv

33、ery. 9 Identification and delivery 9.1 The forgings shall be parcelled in batches and packaged so as to protect them from damage in transit. 9.2 To each parcel a durable label shall be attached on which at least the following information shall be given: a) the name or identification symbol of the ma

34、nufacturer of the forgings; b) the quantity of forgings and the design reference; c) the batch number. 9.3 Each delivery shall be accompanied by a release certificate (or a manufacturers declaration of conformity, in accordance withEN10204) giving at least the following information: a) the name and

35、address of the supplier; b) the purchase or requisition number; c) the identity of the forgings schedule; d) the numbers of the applicable International Standards; e) the heat number of the forging stock; f) the batch number; g) the quantity of the forgings and the design reference; h) the test repo

36、rt for the batch; i) the delivery date.3 blankBS ISO 15374:1998 BSI 389 Chiswick High Road London W4 4AL BSIBritishStandardsInstitution BSI is the independent national body responsible for preparing BritishStandards. It presents the UK view on standards in Europe and at the international level. It i

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