1、STD-BSI BS EN 27740-ENGL 1792 Lb24bb7 Ob85537 973 BRITISH STANDARD Instruments for surgery, scalpels with detachable blades, fitting dimensions The European Standard EN 27740 : 1992 with the incorporation of its amendment Al : 1997 has the status of a British Standard ICs 11.040.30 NO COPYING WITHOU
2、T BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW BS EN 27740 : 1992 SO 7740 : 1985 ncorpmating hrmuhent No. 1 - Issue 2, March 1998 - BS EN 27740 : 1992 - Amd. No. Co operating organizations Date !kt affected The European Coinmittee for Standardization (CE“), under whose supervision this Europe
3、an Standard was prepared, comprises the national standards organizations of the following countries: 9907 Austria Belgium Denmark Finland Fiance Germany Greece Iceland Ireland Italy Luxembourg Ketherlands Norway Portugal Spain Sweden Smi tzerland United Kingdom March 1998 New annex ZA and BS title a
4、ligned with that of EN Oesterreichisclies Norinungsiiistitut Institut belge de normalisation Dansk Standardiseringsraad Suomen Standardisoimisliito, rey. Association francaise de normalisat ion Deutsches Institut fr Normung e.V. Hellenic 0rgaiiizat.ioii for Standardization Technological Institute of
5、 Iceland National Standards Authority of Ireland Ente Nazionale Italiano di Vnificazione Inspection du Travail et des Mines Nederlands Nornialisat ie- instit uiit Norges Standariseriiigsfoi.biiild Instituto Poitugus da Qualidade Asociacin Ecpai?ola de Noiiiializacin y Certificacin St,andardiseriiigs
6、kominissioiieii i Swrige Association suisse de iioi-nialisat ioii British Standards Institution Summary of pages The following table identies the current issue of each page. Issue 1 indicates that a page has been introduced for the first time by amendment. Subsequent issue numbers indicate an update
7、d page. Vertical sidelining on replacement pages indicates the most recent changes (amendment, addition, deletion). Pase I issue Front cover Inside front cover a b i EN title page ll 2 2 1 blank 2 blank 2 Page 2 3 4 5 6 Inside back cover Back cover Oliginai Original Originai original I1 i O BSI 1998
8、 * * m - - STD-BSI BS EN 277qO-ENGL 1772 M 1bZqbb 0b855Y0 Yb8 Issue 2, March 19% BS EN 27740 : 1992 Contents Cooperating organizations Page Inside front cover National foreword i Foreword 2 Specification O Introduction 3 1 Scope and field of application 3 2 Fitting dimensions for blades and handles
9、4 Figures 1 Detachable blade 5 2 Scalpel handle 5 _ National annex NA (informative) Committees responsible Inside back cover National foreword This British Standard has been prepared under the direction of the Health Care Standards Policy Coinmittee and is tlie English language veision of EN 27740 :
10、 1992 Aistruwiu,tts foi- stqyery, scalpels with. detchn bbe bla.des, .fittiny dimens-, including amendment Al, published by the European Comnuttee for Standardization (CEN). It partially supersedes ES 2982 : 1986 and is identical with IS0 7740 : 1986 published by the Intedonal Organization for Stand
11、ardization (ISO). Dimensions for the fitting of scalpels with detachable blades were fiist published in BS 2982 : 1958. I3S 2982 : 1992 only specifies requirements for the materials and packaging of blades and handles of surgical scalpels. WARNING. It should be noted that attempts to engage or disen
12、gage blades and handles that are not manufactured in accordance u-ith these agreed dimensions, or where the scalpel handle is significantly worn, could place the operator at iisk of injury due to sudden freeing or sticking of tlie blade. Provision has not been made for the specification of shapes an
13、d sizes of blades. because they are subject to considerable variation as a result of the many wes to which this equipment is put. Attent.ion is di-awn to the foreword of BS 5194 : Part 1 : 1991, in which the British Standards relating to surgical instruiiients are described. Product cctication. User
14、s of this Biitish Standard are advised to consider the desirability of third party certification of product conformity with this Biitish Standard based on testing and continuing product surveillance which may be coupled with assessment of a suppliers quality syst eins against the appropriate Part of
15、 BS 5750. Enquiries as t.o the availability of third party certification scheines are forwarded by US1 to the Association of Certification Bodies. If a t.hird party certification scheine does not already exist, users should consider appioacliiiig an appropriate body from t,he list of Association iii
16、eiiibeis. Compliance with a British Standard does not of itself confer irnnwnit.y from legal obligations. I i STD.BS1 BS EN 27740-ENGL 1772 D 1b24bb Ob85541 3T4 M EUROPEAN STANDARD NORMEEUROPENNE EUROPISCHE NORM EN 27740 May 1992 +Al November 1997 UW; 615.472.3 Ikscriptois: Medical equipment. surgic
17、al eqiiipiiieiit . scalpels, handles. blades, joining. dimensions English version Instruments for mew, scalpels with detachable blades, f%tmg dimensions (Bo 7740 : 1985) (includes amendment Al : 1997) Instruments chirurgicaux, bistouris 4 lames dtachables, dimensions dassemblage (inclut amendement A
18、l : 1997) Chirurgische Instrumente, Skalpelle mit auswechselbaren Klingen, PalSrnaBe (enthalt nderung Al : 1997) (Is0 7740 : 1985) (Is0 7740 : 1985) This Eui-opeaii %andard was approved by GEN on 1992-05-20. CEN members are boiiiid to comply with the CENZENELEC Internal Regulations which stipulate t
19、.he conditions for giving this European Standard the status of a national standard without any alteration. Up-t.o-date lists aiid bihliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CEN ineinber. This European St,ai-idard
20、exists in three official versions (English, French, German). A veixioii iii any other language made by translation under the responsibility of a CE3 iiieniber into its own language and notified to the Central Secretariat has the same status as the official versioiis. GEN members are the natioi-ial s
21、tandards bodies of Austria, Belgium, Denmark, Finland, Fiance, Germany, Greece, Iceland, Irelaiid, Italy, Luxeinbourg, Netherlaiicls. Norway, Portugal, Spain, Swedeii, Switzerland and United Kingdoin. CEN Europcan Coininittee for Standardization CoiiiitG Europen de Normalisation Etiropiiisches Komit
22、ee fiir Normung Central Secretariat: rile de Stassart 36, B-1050 Brussels O 1992 Copyright. rcscivecl to CISN iiicwlwis Ref. No. EN 27440 : 1992 + AI : 1997 E STD*BSI BS EN 277itII-ENGL 1992 Lb2LibbS Ob855q2 230 M Page 2 EN 27740 : 1992 Issue 2, March 1998 Foreword This European Standard is the endo
23、rsement of IS0 X40. Endorsement of IS0 7740 was recoiiimended by CEN/lkchnical Committee 205 Non-active medical devices under whose competence this European Standard will henceforth fall. National standards identical to this European Standard will be published at the latest by 92-11-30 and conflicti
24、ng national standards shall be withdrawn at the latest by 92-1 1-30. The standard was approved and, in accordance with the CENCENELEC Internal Regulations, the following countiies are bound to implement this European Standard: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ire
25、land, Italy, Luxembourg, Netherlands, Norway. Portugal, Spain, Sweden, Switzerland, United Kingdom. Foreword to amendment Al This amendment EN 27740 : 199YA1: 1997 to EN 27740 : 1992 has been prepared by Technical Committee CEN/rC 26 Non-active medid devices, the secretariat of which is held by BI.
26、This amendnient to the European standard EN 27740 : 1992 shall be given the status of a national standard, either by publication of an identicai text or by endorsement, at the latest by May 1998, and conflicting national standards shail be withdrawn at the latest by May 1998. This amendment consists
27、 of annex ZA to EN 27740 : 1992. For reationship with EU Directive(s), see informative Annex ZA, which is an integral part of this standard. According to CENKENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard Aus
28、tria, Beigim, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Itay, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Page 3 EN 27740 : 1992 STD.BS1 BS EN 27740-ENGL 1772 Lb24bb7 Ob85543 177 Instruments for surgery - Scalpels w
29、ith detachable blades - Fitting dimensions O Introduction This International Standard has been prepared to meet the need for good fitting and interchangeability of detachable blades for scalpels. Scalpel blades and handles currently in use are manufactured with fitting dimensions that do not always
30、ensure a satisfactory fit be tween blades and handles manufactured in different countries or by different manufacturers. A transitional period during which the fitting dimensions specified in this International Standard may be gradually adopted should last for five years and ends therefore on 31 Dec
31、ember 1990. II = 1 Scope and field of application rn - This International Standard lays down the dimensions of two sizes of fitting features for detachable scalpel blades and the handles with which they are used. II * cn * pabe 4 EN 27740 : 1992 Blade Handle STD.BS1 BS EN 277qO-ENGL 1992 = lb2qbb9 O
32、bLi55qq 003 = E Illax. I min. 123 - 300 4.40 4,50 17.73 17.81 2.31 2.41 1,12 1.17 9 a d e I 0,5O min. max. min. max. min. IlWX. min. 300 4.50 4,65 17,B 17.90 2.43 2.48 1,18 2 Fitting dimensions for blades and handles Blade Handle 2.1 Small fitting feature (No. 31 Fitting dimensions I/ I a E d e f 0,
33、5O min. Illax. min. max. min. max. min. l7WX. min. 350 7.50 7.65 24.20 24.27 3,72 3,77 1,s 2.00 - 350 7,40 7.50 24.10 24,18 3.60 3.70 1,88 1,93 13 The fitting dimensions for blades and handles with a small fitting feature shall be in accordance with table 1 and figures 1 and 2. Table 1 Dimensions in
34、 millimetres I Fitting dimensions I 2.2 Large fitting feature (No. 4) The fitting dimensions for blades and handles with a large fitting feature shall be in accordance with table 2 and figures 1 and 2. at m at Page 5 EN 27740 : 1992 STD-BSI BS EN 277YO-ENGL 1992 Lb24bb9 Ob85545 T4T W Dimensions in m
35、ilimetres 0.42 fining area only) (For the Figure 1 - Detachable blade NOTE - The design of the blade is intended to be illustrative but does not otherwise form part of the requirements laid down in this International Standard. Dimensions in millimetres i -_ - I w I c E 0- OLn O0 .- ? -f, -a aJ - Fig
36、ure 2 - Scalpel handle Page 6 EN 27740 : 1992 Clanse/subciause of this European Standard Lb24bb ObA554b 98b = Corresponding Essential Comments Requirement of Directive 9W425EC Annex ZA (informative) Clauses of this European Standard addressing essential requirements or other provisions of EU Directi
37、ves This European Stanard has been prepared under a mandate given to CEN by the European Commission and the European Free We Association and supports essential requirements of EU Directive 9342lEEC. WARNING. Other requirements and other EU Directives may be applicable to the product(s) fakg within t
38、he The foliowing ciauses of this standard are likely to support requirements of Directive 93/42EEC. Compliance with these clauses of this standard provides one means of conforming with the specific essentid requirements of the Directive concerned and associated EFTA reguMons. scope of this standara
39、I nble ZA.l C.orrespondence between this European Standard and EU Directives I 12 I 2, 3, 9.1 0 BSI 1998 - STD-BSI BS EN 277LiO-ENGL 1792 m 1b2LibbS 0b855Y7 812 m BS EN 27740 : 1992 National annex NA (informative) Committees responsible The United Kingdom participation in the preparation of this Eur
40、opean Standard was entrusted by the Health Care Standards Policy Committee (HCC-) to %clinical 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 P
41、roducts Association National Association of Theatre Nurses Royal College of Nursing Royal College of Surgeons of Edinburgh Royal College of Surgeons of England BS EN 27740 : 1992 IS0 7740 : 1985 BSI 389 Chiswick High Road London w4 4AL BSI - British Standards Institution BSI is the independent natio
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