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About This Item

 

Full Description

BS EN 13795-1:2019 specifies information to be supplied to users and third party verifiers in addition to the usual labelling of medical devices (see EN 1041 and EN ISO 15223-1), concerning manufacturing and processing requirements. This document gives information on the characteristics of single-use and reusable surgical gowns and surgical drapes used as medical devices for patients, clinical staff and equipment, intended to prevent the transmission of infective agents between clinical staff and patients during surgical and other invasive procedures. This document specifies test methods for evaluating the identified characteristics of surgical drapes and gowns and sets performance requirements for these products.

Cross References:
EN ISO 22612:2005
EN 29073-3:1992
EN ISO 13938-1:1999
ISO 9073-10:2003
ISO 139:2005/AMD 1:2011
EN ISO 9073-10:2004
ISO 11737-1:2018
EN ISO 10993-1:2009
ISO 22610:2006 Ed 1
EN ISO 811:2018
EN ISO 139:2005
ISO 10993-1:2009
EN ISO 11737-1:2018
ISO 22612:2005
ISO 811:2018
EN ISO 22610:2006
ISO 13938-1:1999
ISO 139:2005
ISO 9073-6
EN ISO 11607-1
ISO 15223-1
EN ISO 9237
EN 62366
ISO 13485
EN ISO 11092
ISO 9237
EN ISO 10993-10
ISO 9073-11
ISO 11092
EN ISO 9073-12
EN 1041
EN ISO 15223-1
EN 14065
ISO 11607-2
EN ISO 11607-2
EN ISO 9073-11
ISO 11607-1
ISO 10993-10
ISO 10993-5
EN ISO 13485
EN ISO 10993-5
EN ISO 11810
EN ISO 15797
ISO 15797
ISO 9073-12
ISO 11810
EN ISO 9073-6


Replaces BS EN 13795:2011+A1:2013 which remains current

All current amendments available at time of purchase are included with the purchase of this document.
 

Document History

  1. BS EN 13795-1:2019

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    Surgical clothing and drapes. Requirements and test methods-Surgical drapes and gowns

    • Most Recent
  2. BS EN 13795:2011+A1:2013


    Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment. General requirements for manufacturers, processors and products, test methods, performance requirements and performance levels

    • Historical Version
  3. BS EN 13795:2011


    Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment. General requirements for manufacturers, processors and products, test methods, performance requirements and performance levels

    • Historical Version
  4. BS 09/30190221 DC


    BS EN 13795. Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment. General requirements for manufacturers, processors and products, test methods, performance requirements and performance levels

    • Historical Version
  5. BS EN 13795-2:2004+A1:2009


    Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment-Test methods

    • Historical Version
  6. BS EN 13795-3:2006+A1:2009


    Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment-Performance requirements and performance levels

    • Historical Version
  7. BS EN 13795-1:2002+A1:2009


    Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment-General requirements for manufacturers, processors and products

    • Historical Version
  8. BS EN 13795-3:2006


    Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment. Performance requirements and performance levels

    • Historical Version
  9. BS EN 13795-2:2004


    Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment. Test methods

    • Historical Version
  10. BS EN 13795-1:2002


    Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment. General requirements for manufacturers, processors and products

    • Historical Version