BS-EN-13795-2-2004.pdf
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1、BRITISH STANDARD BS EN 13795-2:2004 Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment Part 2: Test methods The European Standard EN 13795-2:2004 has the status of a British Standard ICS 11.140 ? BS EN 13795-2:2004 This British Standard was
2、 published under the authority of the Standards Policy and Strategy Committee on 6 December 2004 BSI 6 December 2004 ISBN 0 580 44954 8 National foreword This British Standard is the official English language version of EN 13795-2:2004. The UK participation in its preparation was entrusted by Techni
3、cal 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-references The British Standards which implement international or
4、 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 Standards Online. This publication does not purport to incl
5、ude 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 to the responsible international/European committee any enqui
6、ries 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 inside front cover, the EN title page, pages 2 to 10, an inside b
7、ack cover and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. DateComments EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 13795-2 November 2004 ICS 11.140 English version Surgical drapes
8、, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 2: Test methods Champs chirurgicaux, casaques et tenues de blocs, utiliss comme dispositifs mdicaux, pour les patients, le personnel medical et les quipements - Partie 2: Mthodes dessai Operationsa
9、bdecktcher, -mntel und Rein-Luft-Kleidung zur Verwendung als Medizinprodukte fr Patienten, Klinikpersonal und Gerte - Teil 2: Prfverfahren This European Standard was approved by CEN on 15 October 2004. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the cond
10、itions 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
11、 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 Aust
12、ria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDI
13、ZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2004 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 13795-2:2004: E EN 13795-2:2004 (E) 2 Contents Page For
14、eword3 Introduction.4 1 Scope 5 2 Normative references5 3 Terms and definitions .5 4 Testing requirements 6 4.1 General6 4.2 Atmospheres for conditioning and testing.6 5 Test methods6 5.1 Test method for evaluation of cleanliness microbial6 5.2 Test method for evaluation of cleanliness particulate m
15、atter .6 5.3 Test method for evaluation of linting.7 5.4 Test method for evaluation of resistance to liquid penetration7 5.5 Test method for evaluation of bursting strength in dry and wet state.7 5.6 Test method for evaluation of tensile strength in dry and wet state7 5.7 Test methods for evaluation
16、 of liquid control 7 5.8 Test method for evaluation of resistance to dry microbial penetration.8 5.9 Test method for evaluation of resistance to wet microbial penetration8 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC9 Bib
17、liography10 EN 13795-2:2004 (E) 3 Foreword This document (EN 13795-2:2004) 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 given the status of a national standard, either by publication of an i
18、dentical text or by endorsement, at the latest by May 2005, and conflicting national standards shall be withdrawn at the latest by May 2005. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential require
19、ments of EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document. EN 13795 is expected to consist of the following parts under the general title “Surgical drapes, gowns and clean air suits, used as medical devices, for patients, cl
20、inical staff and equipment“: Part 1: General requirements for manufacturers, processors and products Part 2: Test methods Part 3: Performance requirements Originally EN 13795 was also to include Part 3: Test method for resistance to dry microbial penetration and Part 4: Test method for resistance to
21、 wet microbial penetration. However, it has been decided that these parts will now be developed by the Vienna Agreement/CEN lead route in conjunction with ISO/TC 94/SC 13. As a result, what was to have been EN 13795-3 is published as EN ISO 22612 Clothing for protection against infectious agents Tes
22、t method for resistance to dry microbial penetration, what was to have been EN 13795- 4 will be published as EN ISO 22610 Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff, and equipment - Test method to determine the resistance to wet bacterial penetr
23、ation (ISO/DIS 22610:2004) and what was to have been EN 13795-5 will be published as EN 13795-3. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic,
24、 Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EN 13795-2:2004 (E) 4 Introduction General requirements for surgical
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