【BS英国标准】BS EN 13795-3-2006 Surgical drapes, gowns and clean air suits, used as medical devices for.pdf
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1、BRITISH STANDARD BS EN 13795-3:2006 Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment Part 3: Performance requirements and performance levels The European Standard EN 13795-3:2006 has the status of a British Standard ICS 11.140 ? Licensed
2、Copy: AUB User, na, Sat Aug 04 06:51:11 GMT+00:00 2007, Uncontrolled Copy, (c) BSI BS EN 13795-3:2006 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 January 2007 BSI 2007 ISBN 978 0 580 50107 4 National foreword This British Standard was
3、published by BSI. It is the UK implementation of EN 13795-3:2006. The UK participation in its preparation was entrusted by Technical Committee CH/205, Non-active medical devices, to Subcommittee CH/205/1, Medical textiles. A list of organizations represented on CH/205/1 can be obtained on request to
4、 its secretary. 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 cannot confer immunity from legal obligations. Amendments issued since publication Amd. No. DateComments Lice
5、nsed Copy: AUB User, na, Sat Aug 04 06:51:11 GMT+00:00 2007, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 13795-3 June 2006 ICS 11.140 English Version Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - P
6、art 3: Performance requirements and performance levels Champs chirurgicaux, casaques et tenues de bloc utiliss en tant que dispositifs mdicaux pour les patients, le personnel et les quipements - Partie 3 : Exigences et seuil de performance Operationsabdecktcher, -mntel und Rein-Luft-Kleidung zur Ver
7、wendung als Medizinprodukte fr Patienten, Klinikpersonal und Gerte - Teil 3: Gebrauchsanforderungen und Leistungsstufen This European Standard was approved by CEN on 27 April 2006. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving thi
8、s 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 (E
9、nglish, 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, Cyprus,
10、 Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT
11、 EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2006 CENAll rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 13795-3:2006: E Licensed Copy: AUB User, na, Sat Aug 04 06:51:11 GM
12、T+00:00 2007, Uncontrolled Copy, (c) BSI EN 13795-3:2006 (E) 2 Contents Page Foreword3 Introduction.4 1 Scope5 2 Normative references5 3 Terms and definitions .5 4 Performance requirements.6 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Direc
13、tive 93/42/EEC concerning medical devices 10 Bibliography11 Licensed Copy: AUB User, na, Sat Aug 04 06:51:11 GMT+00:00 2007, Uncontrolled Copy, (c) BSI w w w . b z f x w . c o m EN 13795-3:2006 (E) 3 Foreword This document (EN 13795-3:2006) has been prepared by Technical Committee CEN/TC 205 “Non-ac
14、tive medical devices”, the secretariat of which is held by DIN. 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 December 2006, and conflicting national standards shall be withdrawn at the latest b
15、y December 2006. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For relationship with EU Directive, see informative Annex ZA, which is an integral part of this do
16、cument. EN 13795 consists of the following parts under the general title “Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment”. Part 1: General requirements for manufacturers, processors and products Part 2: Test methods Part 3: Performance
17、 requirements and performance levels Attention is also drawn to the following: 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 penetration (ISO 22610:2006) EN ISO 226
18、12 Clothing for protection against infectious agents Test method for resistance to dry microbial penetration (ISO 22612:2005) According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Bel
19、gium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Licensed Copy: AUB User, na, Sa
20、t Aug 04 06:51:11 GMT+00:00 2007, Uncontrolled Copy, (c) BSI w w w . b z f x w . c o m EN 13795-3:2006 (E) 4 Introduction The series of EN 13795 specifies requirements for single-use and reusable coverings (i. e. surgical gowns, surgical drapes and clean air suits) used as medical devices for patien
21、ts, clinical staff and equipment and intended to prevent the transmission of infective agents between patients and clinical staff during invasive surgical procedures. General requirements for surgical drapes, gowns and clean air suits, used as medical devices, for patients clinical staff and equipme
22、nt are specified in EN 13795-1. In this respect EN 13795-1 specifies the relevant characteristics to be evaluated for products covered by this European Standard. EN 13795-2 specifies test methods for evaluating these characteristics. NOTE For more information on products contained within the scope o
23、f this European Standard it is recommended to refer to EN 13795-1. Licensed Copy: AUB User, na, Sat Aug 04 06:51:11 GMT+00:00 2007, Uncontrolled Copy, (c) BSI w w w . b z f x w . c o m EN 13795-3:2006 (E) 5 1 Scope This part of the series of EN 13795 specifies performance requirements for surgical d
24、rapes, gowns and clean air suits. NOTE General performance requirements are specified for various characteristics as per EN 13795-1:2002 Tables 1, 2 and 3 and should be evaluated according to EN 13795-2, EN ISO 22610 and EN ISO 22612. 2 Normative references The following referenced documents are ind
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