BS-EN-13726-6-2003.pdf
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1、BRITISH STANDARD BS EN 13726-6:2003 Non-active medical devices Test methods for primary wound dressings Part 6: Odour control The European Standard EN 13726-6:2003 has the status of a British Standard ICS 11.120.20 ? Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:54:03 GMT+00:00 2006, Unc
2、ontrolled Copy, (c) BSI BS EN 13726-6:2003 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 13 May 2003 BSI 13 May 2003 ISBN 0 580 41798 0 National foreword This British Standard is the official English language version of EN 13726-6:2003. The
3、 UK participation in its preparation was entrusted by Technical Committee CH/205, Non-active medical devices, to Subcommittee CH/205/1, Medical textiles, which has the responsibility to: A list of organizations represented on this subcommittee can be obtained on request to its secretary. Cross-refer
4、ences The British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British
5、 Standards Online. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present t
6、o the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an insid
7、e front cover, the EN title page, pages 2 to 8, an inside back cover and a back cover. The BSI copyright date displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. DateComments Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:54
8、:03 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 13726-6 April 2003 ICS 11.120.20 English version Non-active medical devices - Test methods for primary wound dressing - Part 6: Odour control Dispositifs mdicaux non-actifs - Mthodes dessai pour les p
9、ansements primaires en contact avec la plaie - Partie 6: Contrle de lodeur Nichtaktive Medizinprodukte - Prfverfahren fr primre Verbandstoffe (Wundauflagen) - Teil 6: Geruchsbindung This European Standard was approved by CEN on 28 February 2003. CEN members are bound to comply with the CEN/CENELEC I
10、nternal 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 Management Centre or to any CEN memb
11、er. 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 Management Centre has the same status as the official versions. CEN members a
12、re the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT E
13、UROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2003 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 13726-6:2003 E Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29
14、 08:54:03 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 13726-6:2003 (E) 2 Contentspage Foreword3 Introduction.4 1Scope 5 2Terms and definitions5 3Test method for odour penetration5 3.1Significance and use .5 3.2Equipment.5 3.3Procedure .6 3.4Results7 3.5Test report 7 Licensed Copy: sheffieldun shef
15、fieldun, na, Sun Oct 29 08:54:03 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 13726-6:2003 (E) 3 Foreword This document (EN 13726-6:2003) has been prepared by Technical Committee CEN /TC 205, “Non-active medical devices“, the secretariat of which is held by BSI. This European Standard shall be give
16、n the status of a national standard, either by publication of an identical text or by endorsement, at the latest by October 2003, and conflicting national standards shall be withdrawn at the latest by October 2003. EN 13726 consists of the following Parts under the general title Non-active medical d
17、evices - Test methods for primary wound dressings: Part 1: Aspects of absorbency Part 2: Moisture vapour transmission rate of permeable film dressings Part 3: Waterproofness Part 4: Conformability Part 5: Bacterial barrier properties Part 6:Odour control According to the CEN/CENELEC Internal Regulat
18、ions, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Swede
19、n, Switzerland and the United Kingdom. Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:54:03 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 13726-6:2003 (E) 4 Introduction EN 13726 gives test methods and does not contain performance requirements. EN 13726-6 describes a test method for odour
20、 control of primary wound dressings. Test methods for other aspects of primary wound dressings are described in other parts of EN 13726. Licensed Copy: sheffieldun sheffieldun, na, Sun Oct 29 08:54:03 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 13726-6:2003 (E) 5 1 Scope This European Standard des
21、cribes a test method for the evaluation of the resistance of primary wound dressings to penetration by odour. 2 Terms and definitions For the purposes of this European Standard, the following terms and definitions apply: 2.1 primary wound dressing material or combination of materials, in any shape,
22、form or size that is intended to remain in direct contact with a wound NOTEPrimary wound dressing are used as mechanical barriers, for the absorption or transmission of exudates, to manage the micro-environment of the wound, and can enable the wound to heal by primary or secondary intent. Devices wh
23、ich have a metabolic, pharmacological or immunological interaction as their primary intent are excluded. 3 Test method for odour penetration 3.1 Significance and use This test is designed to assess the resistance of primary wound dressings to penetration by odours. It only applies to dressings of a
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