1、BRITISH STANDARD BSEN 27740:1992 ISO7740:1985 Incorporating Amendment No.1 Instruments for surgery, scalpels with detachable blades, fitting dimensions The European Standard EN27740:1992 with the incorporation of its amendment A1:1997 has the status of a British Standard ICS11.040.30BSEN27740:1992 T
2、his British Standard, having been prepared under the directionof the Health Care Standards Policy Committee, waspublished underthe authorityof theStandards Boardand comes into effect on 15 October1992 BSI04-1999 The following BSI references relate to the work on this standard: Committee reference HC
3、C/43 Draft announced in BSI News August1992 ISBN 0 580 21131 2 Cooperating organizations The European Committee for Standardization (CEN), under whose supervision this European Standard was prepared, comprises the national standards organizations of the following countries: Austria Oesterreichisches
4、 Normungsinstitut Belgium Institut belge de normalisation Denmark Dansk Standardiseringsraad Finland Suomen Standardisoimisliito, r.y. France Association franaise de normalisation Germany Deutsches Institut fr Normung e.V. Greece Hellenic Organization for Standardization Iceland Technological Instit
5、ute of Iceland Ireland National Standards Authority of Ireland Italy Ente Nazionale Italiano di Unificazione Luxembourg Inspection du Travail et des Mines Netherlands Nederlands Normalisatie-instituut Norway Norges Standardiseringsforbund Portugal Instituto Portugus da Qualidade Spain Asociacin Espa
6、ola de Normalizaciny Certificacin Sweden Standardiseringskommissionen i Sverige Switzerland Association suisse de normalisation United Kingdom British Standards Institution Amendments issued since publication Amd. No. Date Comments 9907 March 1998 New Annex ZA and BS title aligned with that of ENBSE
7、N27740:1992 BSI 04-1999 i Contents Page Cooperating organizations Inside front cover National foreword ii Foreword 2 0 Introduction 3 1 Scope and field of application 3 2 Fitting dimensions for blades and handles 3 Annex ZA (informative) Clauses of this European Standard addressing essential require
8、ments or other provisions of EU Directives 5 National annex NA (informative) Committees responsible 6 Figure 1 Detachable blade 4 Figure 2 Scalpel handle 4 Table 1 3 Table 2 3 Table ZA.1 Correspondence between this European Standardand EU Directives 5BSEN27740:1992 ii BSI 04-1999 National foreword T
9、his British Standard has been prepared under the direction of the Health Care Standards Policy Committee and is the English language version of EN27740:1992 Instruments for surgery, scalpels with detachable blades, fitting dimensions, including amendment A1, published by the European Committee for S
10、tandardization (CEN). It partially supersedes BS2982:1986 and is identical with ISO7740:1985 published by the International Organization for Standardization (ISO). Dimensions for the fitting of scalpels with detachable blades were first published in BS2982:1958. BS2982:1992 only specifies requiremen
11、ts for the materials and packaging of blades and handles of surgical scalpels. WARNING. It should be noted that attempts to engage or disengage blades and handles that are not manufactured in accordance with these agreed dimensions, or where the scalpel handle is significantly worn, could place the
12、operator at risk of injury due to sudden freeing or sticking of the blade. Provision has not been made for the specification of shapes and sizes of blades, because they are subject to considerable variation as a result of the many uses to which this equipment is put. Attention is drawn to the forewo
13、rd of BS5194-1:1991, in which the British Standards relating to surgical instruments are described. 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 contin
14、uing product surveillance which may be coupled with assessment of a suppliers quality systems against the appropriate Part of BS5750. 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
15、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 application. Compliance w
16、ith 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, pagesi andii, theEN title page, pages2 to6 and a back cover. This standard has been updated (see copyright date) and may have had amendment
17、s incorporated. This will be indicated in the amendment table on the inside front cover.EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN27740 May1992 +A1 November1997 UDC615.472.3 Descriptors: Medical equipment, surgicalequipment, scalpels, handles, blades, joining, dimensions English version In
18、struments for surgery, scalpels with detachable blades, fitting dimensions (includes amendment A1:1997) (ISO7740:1985) Instruments chirurgicaux, bistouris lames dtachables, dimensions dassemblage (inclut lamendement A1:1997) (ISO7740:1985) Chirurgische Instrumente, Skalpelle mit auswechselbaren Klin
19、gen, Pamae (enthlt nderung A1:1997) (ISO7740:1985) This European Standard was approved by CEN on1992-05-20. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alterat
20、ion. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translat
21、ion under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg,
22、Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. CEN European Committee for Standardization Comit Europen de Normalisation Europisches Komitee fr Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1992 Copyright reserved to CEN members Ref. No. EN27440:1992
23、+A1:1997EEN27740:1992 BSI 04-1999 2 Foreword This European Standard is the endorsement of ISO7740. Endorsement of ISO7740 was recommended by CEN/Technical Committee205 “Non-active medical devices” under whose competence this European Standard will henceforth fall. National standards identical to thi
24、s European Standard will be published at the latest by92-11-30 and conflicting national standards shall be withdrawn at the latest by92-11-30. The standard was approved and, in accordance with the CEN/CENELEC Internal Regulations, the following countries are bound to implement this European Standard
25、: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom. Foreword to amendment A1 This amendment EN27740:1992/A1:1997 to EN27740:1992 has been prepared by Technical Committee CEN/TC2
26、05 “Non-active medical devices”, the secretariat of which is held by BSI. This amendment to the European Standard EN27740:1992 shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by May1998, and conflicting national standards
27、shall be withdrawn at the latest by May1998. This amendment consists of Annex ZA to EN27740:1992. For relationship with EU Directive(s), seeinformative Annex ZA, which is an integral part of this standard. According to CEN/CENELEC Internal Regulations, the national standards organizations of the fol
28、lowing countries are bound to implement this European Standard: Austria, Belgium, CzechRepublic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom.EN27740:1992 BSI 04-1999 3 0 Introduction
29、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 ensure a satisfactory fit between blades and handles manuf
30、actured 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 on31 December1990. 1 Scope and field of application This Internation
31、al Standard lays down the dimensions of two sizes of fitting features for detachable scalpel blades and the handles with which they are used. 2 Fitting dimensions for blades and handles 2.1 Small fitting feature (No.3) The fitting dimensions for blades and handles with a small fitting feature shall
32、be in accordance with Table 1 and Figure 1 and Figure 2. Table 1 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 Figure 1 and Figure 2. Table 2 Dimensions in millimetres Fittingdimensions ! c d e f l
33、0,5 min. max. min. max. min. max. min. max. min. Blade 30 4,50 4,65 17,83 17,90 2,43 2,48 1,18 1,23 Handle 30 4,40 4,50 17,73 17,81 2,31 2,41 1,12 1,17 9 Dimensions in millimetres Fittingdimensions ! c d e f l 0,5 min. max. min. max. min. max. min. max. min. Blade 35 7,50 7,65 24,20 24,27 3,72 3,77
34、1,95 2,00 Handle 35 7,40 7,50 24,10 24,18 3,60 3,70 1,88 1,93 13EN27740:1992 4 BSI 04-1999 NOTEThe design of the blade is intended to be illustrative but does not otherwise form part of the requirements laid down in this International Standard. Figure 1 Detachable blade Figure 2 Scalpel handleEN2774
35、0:1992 BSI 04-1999 5 Annex ZA (informative) Clauses of this European Standard addressing essential requirements or other provisions of EU Directives This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association and supports e
36、ssential requirements of EU Directive93/42/EEC. WARNING. Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. The following clauses of this standard are likely to support requirements of Directive93/42/EEC. Compliance with these cl
37、auses of this standard provides one means of conforming with the specific essential requirements of the Directive concerned and associated EFTA regulations. Table ZA.1 Correspondence between this European Standard and EU Directives Clause/subclause of this European Standard Corresponding Essential R
38、equirement of Directive93/42/EEC Comments 2 2, 3, 9.1EN27740:1992 6 BSI 04-1999 National annex NA (informative) Committees responsible The United Kingdom participation in the preparation of this European Standard was entrusted by the Health Care Standards Policy Committee (HCC/-) to Technical Commit
39、tee 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 Theatre Nurses Royal College of Nursing Royal College of
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