BS-ISO-15374-1998.pdf
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1、BRITISH STANDARD BS ISO 15374:1998 Implants for surgery Requirements for production of forgings ICS 11.040.40 Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:14:47 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 15374:1998 This British Standard, having been prepared under the direction o
2、f the Health and Envirnment Sector Board, was published under the authority of the Standards Board and comes into effect on 15 October 1998 BSI 06-1999 ISBN 0 580 30614 3 National foreword This British Standard reproduces verbatim ISO 15374:1998 and implements it as the UK national standard. It supe
3、rsedes BS 7254-6.1:1990 which is withdrawn The UK participation in its preparation was entrusted to Technical Committee CH/18, Surgical impland materials, which has the responsibility to: aid enquirers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
4、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 on request to its secretary. Cross-references The British S
5、tandards 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 the BSI Standards Electronic Catalogue. A British Sta
6、ndard 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. Summary of pages This document comprises a front cover
7、, an inside front cover, pages i and ii, the ISO title page, pages ii to iv, pages 1 and 2 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. Amendments issued since
8、publication Amd. No.DateComments Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:14:47 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 15374:1998 BSI 06-1999i Contents Page National foreword Inside front cover Foreword iii Text of ISO 15374 1 Licensed Copy: sheffieldun sheffieldun, na, S
9、un Nov 26 02:14:47 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii blank Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:14:47 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:14:47 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 15374:19
10、98 ii BSI 06-1999 Contents Page Foreword iii 1 Scope1 2 Normative references1 3 Definitions1 4 Composition of forging stock1 5 Process control1 6 Mechanical testing of forgings2 7 Microstructure2 8 Traceability2 9 Identification and delivery2 Descriptors: Medical equipment, surgical implants, metall
11、urgical products, forgings, specifications, manufacturing requirements, microstructure, traceability, tests, mechanical tests, identification methods, labels. Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:14:47 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 15374:1998 BSI 06-1999iii F
12、oreword ISO (the International Organization 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 te
13、chnical committee has been established 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
14、of electrotechnical standardization. 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. International Standard ISO 15374 was
15、 prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommitee SC 1, Materials. Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:14:47 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iv blank Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 02:14:47 GMT+00:00 2006, Uncontro
16、lled Copy, (c) BSI BS ISO 15374:1998 BSI 06-19991 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 products in the manufacturing of surgical impl
17、ants. 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 time of publication, the editions indicated
18、 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 maintain registers of currently valid Internat
19、ional 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: Wrought titanium 6-aluminium 4-vanadium all
20、oy. 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 for surgery Metallic materials Part 7: Forge
21、able 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 9: Wrought high nitrogen stainless steel. I
22、SO 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 surgery Metallic materials Part 12: Wrought co
23、balt-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 bars1). NOTEThe above reference will be replaced by references to appropriate Inte
24、rnational 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 batch lot forgings to the same pattern produced
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