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  • EN 13795-3:2006+A1:2009

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 3: Performance requirements and performance levels

    Available format(s): 

    Superseded date:  01-03-2011

    Language(s): 

    Published date:  15-07-2009

    Publisher:  Comite Europeen de Normalisation

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    Table of Contents - (Show below) - (Hide below)

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Performance requirements
    Annex ZA (informative) - Relationship between this European
                             Standard and the Essential
                             Requirements of EU Directive
                             93/42/EEC on Medical Devices
    Bibliography

    Abstract - (Show below) - (Hide below)

    This part of the series of EN 13795 specifies performance requirements for surgical drapes, gowns and clean air suits.NOTEGeneral 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.

    General Product Information - (Show below) - (Hide below)

    Committee CEN/TC 205
    Development Note Supersedes PREN 13795-3. (12/2007) 2006 Edition Re-Issued in July 2009 & incorporates AMD 1 2009. (08/2009)
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Superseded
    Superseded By
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    07/30166924 DC : DRAFT AUG 2007 BS EN 868-2 - PACKAGING MATERIALS FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: STERILIZATION WRAP - REQUIREMENTS AND TEST METHODS
    DIN EN ISO 22610:2015-12 (Draft) 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
    PREN 868-2 : DRAFT 2015 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: STERILIZATION WRAP - REQUIREMENTS AND TEST METHODS
    BS EN ISO 22610:2006 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
    DIN EN ISO 22610:2006-10 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 22610:2006 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)
    15/30325855 DC : 0 BS EN 868-2 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: STERILIZATION WRAP - REQUIREMENTS AND TEST METHODS
    ISO 22610:2006 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

    Standards Referencing This Book - (Show below) - (Hide below)

    EN 13795-1:2002+A1:2009 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
    EN ISO 22610:2006 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)
    89/686/EEC : 1989 AMD 5 2012 COUNCIL DIRECTIVE OF 21 DECEMBER 1989 ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO PERSONAL PROTECTIVE EQUIPMENT
    ISO 22612:2005 Clothing for protection against infectious agents Test method for resistance to dry microbial penetration
    ISO 22610:2006 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
    EN 13795-2:2004+A1:2009 Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 2: Test methods
    EN ISO 22612:2005 Clothing for protection against infectious agents - Test method for resistance to dry microbial penetration (ISO 22612:2005)
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