【BS标准word原稿】BS EN 124391999 Sterile rectal catheters for single use.doc

豆丁网：BRITISH STANDARDSterile rectal catheters for single useThe European Standard EN 12439:1998 has the status of aBritish StandardICS 11.040.20| BS EN12439:1999|Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:24:46 GMT+00:00 2006, Uncontrolled Copy, (c) BSI|NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBS EN 12439:1999National forewordThis British Standard is the English language version of EN 12439:1998.The UK participation in its preparation was entrusted to Technical CommitteeCH/27, Medical plastics tubing, which has the responsibility to:Ð aid enquirers to understand the text;Ð present to the responsible European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed;Ð 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-referencesThe British Standards which implement international or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled ªInternational Standards Correspondence Indexº, or by using theªFindº facility of the BSI Standards Electronic Catalogue.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 of itself confer immunity from legal obligations.Summary of pagesThis document comprises a front cover, an inside front cover, the EN title page, pages 2 to 4, an inside back cover and a back cover.Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:24:46 GMT+00:00 2006, Uncontrolled Copy, (c) BSIAmd. No.DateText affectedThis British Standard, having been prepared under the direction of the Health and Environment Sector Committee, was published under the authority of the StandardsCommittee and comes into effect on 15 April 1999BSI 04-1999ISBN 0 580 30685 2Amendments issued since publicationLicensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:24:46 GMT+00:00 2006, Uncontrolled Copy, (c) BSIEUROPEAN STANDARDEN 12439NORME EUROPE ENNEEUROPAÈ ISCHE NORMOctober 1998ICS 11.040.20Descriptors: medical equipment, rectal catheters, disposable equipment, definitions, specifications, dimensions, designation, tensile strength, gas permeability, labelling, packing, storageEnglish versionSterile rectal catheters for single useSondes rectales ste riles non re utilisables Sterile Rektalkatheter zur einmaligen VerwendungThis European Standard was approved by CEN on 2 October 1998.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 alteration. 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 translation 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, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.CENEuropean Committee for Standardization Comite Europe en de Normalisation EuropaÈ isches Komitee fuÈ r NormungCentral Secretariat: rue de Stassart 36, B-1050 Brussels1998 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN nationalMembers.Ref. No. EN 12439:1998 EPage EN 12439:1998BSI 04-1999ForewordThis European Standard has been prepared byTechnical Committee CEN/TC 205, Non-active medicalContentsPageLicensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:24:46 GMT+00:00 2006, Uncontrolled Copy, (c) BSIdevices, the Secretariat of which is held by BSI.This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by April 1999, and conflicting national standards shall be withdrawn atthe latest by April 1999.According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom.The document is based on DIN 13273-4, Catheters for medical use Ð Part 4: Single-use rectal catheters.Annex A is given for information only.Foreword 21Scope 32Normative references 33Definitions 34Requirements 35Labelling 4Annex A (informative) Bibliography 4Page 3EN 12439:19981 ScopeThis European Standard specifies requirements for single-use rectal catheters intended to be inserted into the rectum of a patient, for emptying, rinsing or filling purposes.2 Normative referencesThis European Standard incorporates by dated or undated reference provisions from other publications. The normative references are cited at the appropriate places in the text and the publications are listed hereafter. For dated references, subsequent amendments to, or revisions of any of these publications apply to this European Standard onlywhen incorporated in it by amendment or revision. For undated references, the latest edition of the publication referred to applies.EN 556:1994 + A1:1998, Sterilization of medical devices Ð Requirements for terminally-sterilized medical devices to be labelled ªSterileº.EN 1041, Information supplied by the manufacturer with medical devices.EN 1618, Catheters other than intravascular catheters Ð Test methods for common properties.3 DefinitionsFor the purposes of this European Standard, the following definitions apply.3.1rectal cathetermedical device consisting of a catheter tube, which can be fitted with a connector with tapered bore, intended to be inserted into the rectum of a patient3.2 collapseflattening of the shaft, obstructing the flow through the catheter4 Requirements4.1 GeneralThe tests to ascertain that requirements are fulfilled shall be performed on the product in the ready-for-use state.4.2 Dimensions and designationRectal catheter dimensions should be defined as designated in Figure 1.The area of any eye shall not exceed thecross-sectional area of the lumen, and the tip shall be rounded and closed.NOTE The design of the catheter in Figure 1 is an example andis given for information only. The size and position of the catheter eyes should not compromise the stiffness required for catheter insertion.4.3 BiocompatibilityThe catheter shall be evaluated for biocompatibility, and shall be free from biological hazard.NOTE Methods for evaluation for biocompatibility are given in EN 30993.4.4 Kink stabilityNOTE This clause will be prepared when a test method has been developed.4.5 SurfaceWhen the catheter is ready for use (i.e. treated according to the manufacturer's instructions) and is examined by normal or corrected-to-normal vision, the surface of the shaft, tip, and eyes shall appear free from extraneous matter.The shaft and any openings in the tip shall be designed so as to minimize the risk of serious injury to mucous membranes.4.6 Tensile propertiesWhen tested as described in annex B of EN 1618, the catheter shall not break and the catheter and connector shall not become separated at an applied force of 15 N or less.l = effective length1 Closed, rounded tipLicensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:24:46 GMT+00:00 2006, Uncontrolled Copy, (c) BSId = outer diameterFigure 1 Ð Designation of dimensionsBSI 04-1999Page EN 12439:1998BSI 04-1999Licensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:24:46 GMT+00:00 2006, Uncontrolled Copy, (c) BSI4.7 Collapse4.7.1 When tested as described in 4.7.2, the catheter shall not collapse.4.7.2 Place the catheter, with its eyes blocked, in a water bath at a temperature of (37 2) 8C and keep it in the bath until temperature equilibrium has been reached. Apply a pressure of 210 kPa to the catheter for a period of 15 s. Examine the catheter for signs of collapse.4.8 Air leakageWhen tested as described in annex C of EN 1618 at a test pressure of 10 kPa, the joint between the catheter and the connector shall not leak.4.9 SterilityThe catheter shall comply with EN 556:1994 + A1:1998.5 LabellingIn addition to the requirements of EN 1041, the following product-specific details shall be presented on the individual packaging:a) outer diameter, in millimetres, as designated in Figure 1;b) effective length, in millimetres, as designated in Figure 1;c) if the product contains latex, it shall be labelled to that effect.NOTE Other units of measurement can be used in addition to the SI units specified in 5a and 5b.Annex A (informative) BibliographyEN 30993, Biological evaluation of medical devices.blankLicensed Copy: sheffieldun sheffieldun, na, Sat Oct 28 05:24:46 GMT+00:00 2006, Uncontrolled Copy, (c) BSIBSI389 Chiswick High RoadLondonW4 4AL| BSI Ð British Standards Institution| BSI is the independent national body responsible for preparing British Standards. 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