BS 2982-1992 Specification for materials and packaging of surgical scalpels with detachable blades《带可卸刀片的外科解剖刀的材料和包装规范》.pdf

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1、BRITISH STANDARDBS 2982:1992Incorporating Amendments No. 1 and No. 2Specification forMaterials and packaging of surgical scalpels with detachable bladesICS 11.040.30; 55.040BS 2982:1992This British Standard, having been prepared under the direction of the Healthcare Standards Policy Committee, was p

2、ublished under the authority of the Standards Board and comes into effect on 19 November 1992 BSI 20 October 2005First published May 1958Second edition November 1974Third edition July 1986Fourth edition November 1992The following BSI references relate to the work on this standard:Committee reference

3、 HCC/43Draft for comment 92/54501 DCISBN 0 580 21263 7Committees responsible for this British StandardThe preparation of this British Standard was entrusted by the Healthcare Standards Policy Committee (HCC/-) to Technical Committee HCC/43, upon which the following bodies were represented:British St

4、eel IndustryBritish Surgical Trades AssociationDepartment of HealthInstitute of Sterile Services ManagementMedical Sterile Products AssociationNational Association of Theatre NursesRoyal College of NursingRoyal College of Surgeons of EdinburghRoyal College of Surgeons of EnglandAmendments issued sin

5、ce publicationAmd. No. Date Comments8300 February 199515669 October 2005 Indicated by a sideline in the marginBS 2982:1992 BSI 20 October 2005 iContentsPageCommittees responsible Inside front coverForeword ii1Scope 12 References 13 Dimensions of blades and handles 14 Handle 15Blade 16 Packaging of h

6、andles 27 Packaging of blades 28 Marking 2Figure 1 Scalpel handle 1Table 1 Composition of carbon steel for scalpel blades 1List of references Inside back coverBS 2982:1992ii BSI 20 October 2005ForewordThis British Standard has been prepared under the direction of the Healthcare Standards Policy Comm

7、ittee and supersedes BS 2982:1986 which is withdrawn.BS 2982 was first published in 1958 and was revised in 1974.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 revision of BS 2982 introduced amended dimensions for th

8、e 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 Technical Committee 170, Surgical instruments, of the In

9、ternational 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 national standards having the same dimensional requi

10、rements.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 its provisions to requirements for the materials us

11、ed 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 Standard based on testing and continued product survei

12、llance 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 third party certification scheme does not already exist,

13、 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 application.Compliance with a British Standard does not

14、of itself confer immunity from legal obligations.Summary of pagesThis 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 date) and may have had amendments incorporated. This will b

15、e indicated in the amendment table on the inside front cover.BS 2982:1992 BSI 20 October 200511 ScopeThis British Standard specifies requirements for materials and for the packaging of blades and handles of surgical scalpels with detachable blades.NOTE Dimensional requirements for surgical scalpels

16、are specified in BS EN 27740:1992.2 References2.1 Normative referencesThis British Standard incorporates, by reference, provisions 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 ba

17、ck cover. Subsequent amendments to, or revisions of, any of these publications apply to this British Standard only when incorporated in it by updating or revision.2.2 Informative referenceThis British Standard refers to another publication that provides information or guidance. The edition of this p

18、ublication current at the time of issue of this standard is given on the inside back cover, but reference should be made to the latest edition.3 Dimensions of blades and handlesThe dimensions of blades and handles shall be in accordance with BS EN 27740:1992.4 Handle4.1 HardnessThe Vickers hardness

19、of metal handles shall be not less than 140 HV. The Vickers hardness shall be determined on the face of the head of the handle see Figure 1 a) in accordance with BS EN ISO 6507-1:1998.4.2 ConstructionThe handle shall be of one-piece construction.4.3 GrooveThere shall be a groove in the head of the h

20、andle see Figure 1 b). The groove shall be such that when a blade is fitted into the groove, the cutting edge of the fitted blade shall lie in a plane through the linear axis of the handle see Figure 1 b).4.4 FinishThe handle shall be free from burrs and sharp or rough edges.NOTE The handle may have

21、 a matt, polished or other finish, as agreed between the manufacturer and the purchaser.5 Blade5.1 Material5.1.1 Carbon steelBlades made of carbon steel shall have the composition given in Table 1.Table 1 Composition of carbon steel for scalpel bladesRange% (m/m)Carbon 1.20 to 1.30Silicon 0.10 to 0.

22、35Manganese 0.20 to 0.45Chromium 0.10 to 0.40Sulfur 0.025 max.Phosphorous 0.035 max.Figure 1 Scalpel handleBS 2982:19922 BSI 20 October 20055.1.2 Stainless steelBlades 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 Hardness5.2.1 Blad

23、es made from carbon steelThe 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 steelThe Vickers hardness of stainless ste

24、el 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 FinishWhen inspected by normal or corrected vision, the blade shall have a smooth finish and shall be free from burrs and corrosio

25、n.5.4 Cutting edgeThe 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 matterThe blade shall be clean and free from extraneous matter when in

26、spected by normal or corrected vision.6 Packaging of handlesHandles shall be individually packed.7 Packaging of blades7.1 Packages of non-sterile blades7.1.1 Unit containerExcept for blades made of stainless steel, the package shall contain a corrosion-inhibiting material. The blades shall be either

27、 individually wrapped or wrapped in such a manner that the edges cannot come into contact with each other.7.1.2 Outer containerUnit containers shall be packed in an outer container.NOTE The outer container should be sufficiently robust to protect the contents during transit and storage.7.2 Packages

28、of sterile blades7.2.1 Unit containerExcept 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 maintain the sterility of its co

29、ntents under the conditions of handling and storage normally encountered in hospitals and medical practice.7.2.2 Outer containerUnit containers shall be packed in an outer container.NOTE The outer container should be sufficiently robust to protect the contents during transit and storage.8 Marking8.1

30、 HandlesHandles 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. BS 29821).8.2 Packages of handlesPacka

31、ges 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 27740:1992;c) the name or registered trade mark of

32、the manufacturer and/or supplier;d) the number of this British Standard, i.e. BS 2982:19921).8.3 BladesBlades shall be permanently marked with the following:a) the manufacturers designation of blade pattern;b) the name or registered trade mark of the manufacturer.1) Marking BS 2982:1992 on or in rel

33、ation 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 a declaration is not to be confused with third par

34、ty certification of conformity, which may also be desirable.BS 2982:1992 BSI 20 October 200538.4 Packages of non-sterile blades8.4.1 Unit containers for non-sterile bladesPackages of non-sterile blades shall be marked with the following:a) the quantity;b) the manufacturers designation of blade patte

35、rn;c) the name or registered trade mark of the manufacturer and/or supplier;d) the number of this British Standard, i.e. BS 2982:19922).8.4.2 Outer containers for non-sterile bladesOuter containers for packages of blades shall be marked as specified in 8.4.1 with the addition of the size of fitting.

36、8.5 Packages of sterile blades8.5.1 Unit containers for sterile bladesSterile packages shall be marked with the following:a) the 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

37、number;d) the name or registered trade mark of the manufacturer and/or supplier;e) the number of this British Standard, i.e. BS 2982:19922).8.5.2 Outer containers for sterile bladesOuter containers for sterile blades shall be marked with the following:a) description of contents, including quantity,

38、manufacturers designation of blade pattern and the size of fitting;b) the word “STERILE” or equivalent in prominent lettering;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 Sta

39、ndard, i.e. BS 2982:19922).2) 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 responsi

40、bility. Such a declaration is not to be confused with third party certification of conformity, which may also be desirable.4blankBS 2982:1992 BSI 20 October 2005List of references (see clause 2)Normative referencesBS 5194, Surgical instruments. BS 5194-1:1991, Specification for stainless steel. BS E

41、N 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 referenceBS EN ISO 13485:2003, Medical devices Quality management systems Requirements for regulatory purposes3

42、). ISO 7740:1986, Instruments for surgery, Scalpels with detachable blades, Fitting dimensions3). 3) Referred to in the foreword only.BS 2982:1992BSI389 Chiswick High RoadLondonW4 4ALBSI British Standards InstitutionBSI is the independent national body responsible for preparing British Standards. It

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