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1、BRITISH STANDARD BS 2982:1992 Incorporating Amendments No. 1 and No. 2 Specification for Materials and packaging of surgical scalpels with detachable blades ICS 11.040.30; 55.040 Licensed Copy: sheffieldun sheffieldun, na, Mon Nov 27 12:56:34 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 2982:1992 T
2、his British Standard, having been prepared under the direction of the Healthcare Standards Policy Committee, was published under the authority of the Standards Board and comes into effect on 19 November 1992 BSI 20 October 2005 First published May 1958 Second edition November 1974 Third edition July
3、 1986 Fourth edition November 1992 The following BSI references relate to the work on this standard: Committee reference HCC/43 Draft for comment 92/54501 DC ISBN 0 580 21263 7 Committees responsible for this British Standard The preparation of this British Standard was entrusted by the Healthcare S
4、tandards Policy Committee (HCC/-) to Technical Committee HCC/43, upon which the following bodies were represented: British Steel Industry British Surgical Trades Association Department of Health Institute of Sterile Services Management Medical Sterile Products Association National Association of The
5、atre Nurses Royal College of Nursing Royal College of Surgeons of Edinburgh Royal College of Surgeons of England Amendments issued since publication Amd. No.DateComments 8300February 1995 15669October 2005Indicated by a sideline in the margin Licensed Copy: sheffieldun sheffieldun, na, Mon Nov 27 12
6、:56:34 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 2982:1992 BSI 20 October 2005i Contents Page Committees responsible Inside front cover Foreword ii 1Scope1 2References1 3Dimensions of blades and handles1 4Handle1 5Blade1 6Packaging of handles2 7Packaging of blades2 8Marking2 Figure 1 Scalpel han
7、dle1 Table 1 Composition of carbon steel for scalpel blades1 List of references Inside back cover Licensed Copy: sheffieldun sheffieldun, na, Mon Nov 27 12:56:34 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 2982:1992 ii BSI 20 October 2005 Foreword This British Standard has been prepared under the
8、direction of the Healthcare Standards Policy Committee and supersedes BS 2982:1986 which is withdrawn. BS 2982 was first published in 1958 and was revised in 1974. The first revision introduced provisions for scalpel blades made of stainless steel and for sterile packages of blades. The second revis
9、ion of BS 2982 introduced amended dimensions for the fittings whereby blades are attached to handles. Two sizes of fitting were specified, namely the small size (no. 3 fitting) and the large size (no. 4 fitting). The revised dimensions were identical to those given in ISO 7740:1985 prepared by Techn
10、ical Committee 170, Surgical instruments, of the International Organization for Standardization (ISO), and the objective was to ensure that a satisfactory fit was achieved between any combination of blade and handle manufactured in accordance with the British Standard, ISO 7740:1985 or any foreign n
11、ational standards having the same dimensional requirements. This revision of BS 2982 accommodates the implementation of BS EN 27740:1992 Specification for dimensions of surgical scalpels with detachable blades which now specifies only the dimensional requirements. This allows BS 2982 to now restrict
12、 its provisions to requirements for the materials used for surgical scalpels and requirements for the packaging of blades and handles. Product certification. Users of this British Standard are advised to consider the desirability of third party certification of product conformity with this British S
13、tandard based on testing and continued product surveillance which may be coupled with assessment of a suppliers quality systems against BS EN ISO 13485:2003. Enquiries as to the availability of third party certification schemes are forwarded by BSI to the Association of Certification Bodies. If a th
14、ird 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 provisions of a contract. Users of British Standards are responsible for their correct a
15、pplication. 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, pages 1 to 4, an inside back cover and a back cover. This standard has been updated (see copyright
16、date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover. Licensed Copy: sheffieldun sheffieldun, na, Mon Nov 27 12:56:34 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 2982:1992 BSI 20 October 2005 1 1 Scope This British Standard specifi
17、es requirements for materials and for the packaging of blades and handles of surgical scalpels with detachable blades. NOTE Dimensional requirements for surgical scalpels are specified in BS EN 27740:1992. 2 References 2.1 Normative references This British Standard incorporates, by reference, provis
18、ions from specific editions of other publications. These normative references are cited at the appropriate points in the text and the publications are listed on the inside back cover. Subsequent amendments to, or revisions of, any of these publications apply to this British Standard only when incorp
19、orated in it by updating or revision. 2.2 Informative reference This British Standard refers to another publication that provides information or guidance. The edition of this publication current at the time of issue of this standard is given on the inside back cover, but reference should be made to
20、the latest edition. 3 Dimensions of blades and handles The dimensions of blades and handles shall be in accordance with BS EN 27740:1992. 4 Handle 4.1 Hardness The Vickers hardness of metal handles shall be not less than 140 HV. The Vickers hardness shall be determined on the face of the head of the
21、 handle see Figure 1 a) in accordance with BS EN ISO 6507-1:1998. 4.2 Construction The handle shall be of one-piece construction. 4.3 Groove There shall be a groove in the head of the handle see Figure 1 b). The groove shall be such that when a blade is fitted into the groove, the cutting edge of th
22、e fitted blade shall lie in a plane through the linear axis of the handle see Figure 1 b). 4.4 Finish The handle shall be free from burrs and sharp or rough edges. NOTE The handle may have a matt, polished or other finish, as agreed between the manufacturer and the purchaser. 5 Blade 5.1 Material 5.
23、1.1 Carbon steel Blades made of carbon steel shall have the composition given in Table 1. Table 1 Composition of carbon steel for scalpel blades Range % (m/m) Carbon1.20 to 1.30 Silicon0.10 to 0.35 Manganese0.20 to 0.45 Chromium0.10 to 0.40 Sulfur0.025 max. Phosphorous0.035 max. Figure 1 Scalpel han
24、dle Licensed Copy: sheffieldun sheffieldun, na, Mon Nov 27 12:56:34 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 2982:1992 2 BSI 20 October 2005 5.1.2 Stainless steel Blades made of stainless steel shall be made of steel of compositions D, E, F or G in accordance with BS 5194-1:1991. 5.2 Hardness 5
25、.2.1 Blades made from carbon steel The Vickers hardness of carbon steel blades shall be not less than 800 HV. The Vickers hardness shall be determined as near to the cutting edge as practicable in accordance with BS EN ISO 6507-1:1998. 5.2.2 Blades made from stainless steel The Vickers hardness of s
26、tainless steel blades shall be not less than 700 HV. The Vickers hardness shall be determined as near to the cutting edge as practicable in accordance with BS EN ISO 6507-1:1998. 5.3 Finish When inspected by normal or corrected vision, the blade shall have a smooth finish and shall be free from burr
27、s and corrosion. 5.4 Cutting edge The central plane of the cutting edge shall be central with respect to the blade and, when inspected by normal or corrected vision, shall be free from nicks, burrs and feathered edges. 5.5 Freedom from extraneous matter The blade shall be clean and free from extrane
28、ous matter when inspected by normal or corrected vision. 6 Packaging of handles Handles shall be individually packed. 7 Packaging of blades 7.1 Packages of non-sterile blades 7.1.1 Unit container Except for blades made of stainless steel, the package shall contain a corrosion-inhibiting material. Th
29、e blades shall be either individually wrapped or wrapped in such a manner that the edges cannot come into contact with each other. 7.1.2 Outer container Unit containers shall be packed in an outer container. NOTE The outer container should be sufficiently robust to protect the contents during transi
30、t and storage. 7.2 Packages of sterile blades 7.2.1 Unit container Except for blades made of stainless steel, the package shall contain a corrosion-inhibiting material. Each sterile blade shall be individually packed in a sealed container. NOTE The sealed container should be sufficiently robust to m
31、aintain the sterility of its contents under the conditions of handling and storage normally encountered in hospitals and medical practice. 7.2.2 Outer container Unit containers shall be packed in an outer container. NOTE The outer container should be sufficiently robust to protect the contents durin
32、g transit and storage. 8 Marking 8.1 Handles Handles shall be permanently marked with the following: a) the size number appropriate to either small or large fittings in accordance with BS EN 27740:1992; b) name or registered trade mark of the manufacturer; c) the number of this British Standard, i.e
33、. BS 29821). 8.2 Packages of handles Packages containing handles shall be marked with the following: a) the size number appropriate to either small or large fittings in accordance with BS EN 27740:1992, i.e. No. 3 or No. 4; b) the size of fitting, i.e. small or large in accordance with BS EN 27740:1
34、992; c) the name or registered trade mark of the manufacturer and/or supplier; d) the number of this British Standard, i.e. BS 2982:19921). 8.3 Blades Blades shall be permanently marked with the following: a) the manufacturers designation of blade pattern; b) the name or registered trade mark of the
35、 manufacturer. 1) Marking BS 2982:1992 on or in relation to a product represents a manufacturers declaration of conformity, i.e. a claim by or on behalf of the manufacturer that the product meets the requirements of the standard. The accuracy of the claim is solely the claimants responsibility. Such
36、 a declaration is not to be confused with third party certification of conformity, which may also be desirable. Licensed Copy: sheffieldun sheffieldun, na, Mon Nov 27 12:56:34 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 2982:1992 BSI 20 October 2005 3 8.4 Packages of non-sterile blades 8.4.1 Unit
37、containers for non-sterile blades Packages of non-sterile blades shall be marked with the following: a) the quantity; b) the manufacturers designation of blade pattern; c) the name or registered trade mark of the manufacturer and/or supplier; d) the number of this British Standard, i.e. BS 2982:1992
38、2). 8.4.2 Outer containers for non-sterile blades Outer containers for packages of blades shall be marked as specified in 8.4.1 with the addition of the size of fitting. 8.5 Packages of sterile blades 8.5.1 Unit containers for sterile blades Sterile packages shall be marked with the following: a) th
39、e description of the contents, including the manufacturers designation of blade pattern; b) the word “STERILE” in prominent lettering; c) the date of manufacture and/or batch number; d) the name or registered trade mark of the manufacturer and/or supplier; e) the number of this British Standard, i.e
40、. BS 2982:19922). 8.5.2 Outer containers for sterile blades Outer containers for sterile blades shall be marked with the following: a) description of contents, including quantity, manufacturers designation of blade pattern and the size of fitting; b) the word “STERILE” or equivalent in prominent let
41、tering; c) date of manufacture and/or batch number; d) date of sterilization (month and year); e) name and address of the manufacturer and/or supplier; f) the number of this British Standard, i.e. BS 2982:19922). 2) Marking BS 2982:1992 on or in relation to a product represents a manufacturers decla
42、ration of conformity, i.e. a claim by or on behalf of the manufacturer that the product meets the requirements of the standard. The accuracy of the claim is solely the claimants responsibility. Such a declaration is not to be confused with third party certification of conformity, which may also be d
43、esirable. Licensed Copy: sheffieldun sheffieldun, na, Mon Nov 27 12:56:34 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 4 blank Licensed Copy: sheffieldun sheffieldun, na, Mon Nov 27 12:56:34 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 2982:1992 BSI 20 October 2005 List of references (see clause 2) N
44、ormative references BS 5194, Surgical instruments. BS 5194-1:1991, Specification for stainless steel. BS EN 27740:1992, Specification for the dimensions of surgical scalpels with detachable blades. BS EN ISO 6507-1:1998, Metallic materials Vickers hardness test Part 1: Test method. Informative refer
45、ence BS EN ISO 13485:2003, Medical devices Quality management systems Requirements for regulatory purposes3). ISO 7740:1986, Instruments for surgery, Scalpels with detachable blades, Fitting dimensions3). 3) Referred to in the foreword only. Licensed Copy: sheffieldun sheffieldun, na, Mon Nov 27 12:
46、56:34 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 2982:1992 BSI 389 Chiswick High Road London W4 4AL BSI British Standards Institution BSI is the independent national body responsible for preparing British Standards. It presents the UK view on standards in Europe and at the international level. It
47、 is incorporated by Royal Charter. Revisions British Standards are updated by amendment or revision. Users of British Standards should make sure that they possess the latest amendments or editions. It is the constant aim of BSI to improve the quality of our products and services. We would be gratefu
48、l if anyone finding an inaccuracy or ambiguity while using this British Standard would inform the Secretary of the technical committee responsible, the identity of which can be found on the inside front cover. Tel: +44 (0)20 8996 9000. Fax: +44 (0)20 8996 7400. BSI offers members an individual updat
49、ing service called PLUS which ensures that subscribers automatically receive the latest editions of standards. Buying standards Orders for all BSI, international and foreign standards publications should be addressed to Customer Services. Tel: +44 (0)20 8996 9001. Fax: +44 (0)20 8996 7001. Email: ordersbsi-. Standards are also available from the BSI website at http:/www.bsi-. In response to orders for international standards, it is BSI policy to supply the BSI implementation of those that have been published as British St
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