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  • UNI EN 13795 : 2013

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS, TEST METHODS, PERFORMANCE REQUIREMENTS AND PERFORMANCE LEVELS

    Available format(s): 

    Superseded date:  04-07-2019

    Language(s): 

    Published date:  01-01-2013

    Publisher:  Ente Nazionale Italiano di Unificazione (UNI)

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

    PREMESSA
    INTRODUZIONE
    1 SCOPO E CAMPO DI APPLICAZIONE
    2 RIFERIMENTI NORMATIVI
    3 TERMINI E DEFINIZIONI
    4 REQUISITI DI PRESTAZIONE
    5 PROVE
    6 REQUISITI DI FABBRICAZIONE E
      LAVORAZIONE
    7 INFORMAZIONI FORNITE DAL FABBRICANTE
      O DALL'OPERATORE
    APPENDICE A (informativa) - DETTAGLI DELLE VARIAZIONI
                SIGNIFICATIVE TRA LA PRESENTE NORMA
                EUROPEA E L'EDIZIONE PRECEDENTE
    APPENDICE B (normativa) - METODI DI PROVA
    APPENDICE C (informativa) - PREVENZIONE DELL'INFEZIONE
                NELLA SALA OPERATORIA
    APPENDICE D (informativa) - INFORMAZIONI SU ULTERIORI
                CARATTERISTICHE
    APPENDICE ZA (informativa) - RAPPORTO FRA LA PRESENTE
                 NORMA EUROPEA E I REQUISITI ESSENZIALI
                 DELLA DIRETTIVA UE 93/42/CEE SUI
                 DISPOSITIVI MEDICI
    BIBLIOGRAFIA

    Abstract - (Show below) - (Hide below)

    Describes information to be supplied to users and third party verifiers in addition to the usual labelling of medical devices, concerning manufacturing and processing requirements.

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

    Development Note Supersedes UNI EN 13795-1, UNI EN 13795-2 and UNI EN 13795-3. (05/2011) Italian version issued in NOVEMBER 2013. (11/2013)
    Document Type Standard
    Publisher Ente Nazionale Italiano di Unificazione (UNI)
    Status Superseded
    Superseded By
    Supersedes

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

    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)
    ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
    EN 20811 : 1992 TEXTILES - DETERMINATION OF RESISTANCE TO WATER PENETRATION - HYDROSTATIC PRESSURE TEST
    EN ISO 9073-11:2004 Textiles - Test methods for nonwovens - Part 11: Run-off (ISO 9073-11:2002)
    ISO 9237:1995 Textiles — Determination of the permeability of fabrics to air
    ISO 9073-12:2002 Textiles Test methods for nonwovens Part 12: Demand absorbency
    ISO 11737-1:2006 Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products
    EN ISO 9237 : 1995 TEXTILES - DETERMINATION OF PERMEABILITY OF FABRICS TO AIR
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    ISO 11810-2:2007 Lasers and laser-related equipment Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers Part 2: Secondary ignition
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    EN 14065:2016 Textiles - Laundry processed textiles - Biocontamination control system
    ISO 22612:2005 Clothing for protection against infectious agents Test method for resistance to dry microbial penetration
    ISO 11810-1:2005 Lasers and laser-related equipment Test method and classification for the laser resistance of surgical drapes and/or patient protective covers Part 1: Primary ignition and penetration
    EN 29073-3:1992 Textiles - Test methods for nonwovens - Part 3: Determination of tensile strength and elongation
    EN ISO 13938-1 : 1999 TEXTILES - BURSTING PROPERTIES OF FABRICS - PART 1: HYDRAULIC METHOD FOR DETERMINATION OF BURSTING STRENGTH AND BURSTING DISTENSION
    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 11092:2014 Textiles — Physiological effects — Measurement of thermal and water-vapour resistance under steady-state conditions (sweating guarded-hotplate test)
    ISO 9073-11:2002 Textiles — Test methods for nonwovens — Part 11: Run-off
    ISO 9073-10:2003 Textiles Test methods for nonwovens Part 10: Lint and other particles generation in the dry state
    EN 31092:1993/A1:2012 TEXTILES - DETERMINATION OF PHYSIOLOGICAL PROPERTIES - MEASUREMENT OF THERMAL AND WATER-VAPOUR RESISTANCE UNDER STEADY-STATE CONDITIONS (SWEATING GUARDED - HOTPLATE TEST) (ISO 11092:1993/AMD 1:2012)
    EN ISO 9073-10:2004 Textiles - Test methods for nonwovens - Part 10: Lint and other particles generation in the dry state (ISO 9073-10:2003)
    ISO 139:2005 Textiles Standard atmospheres for conditioning and testing
    EN ISO 139:2005/A1:2011 Textiles - Standard atmospheres for conditioning and testing - Amendment 1 (ISO 139:2005/AMD 1:2011)
    EN ISO 11810-1:2009 Lasers and laser-related equipment - Test method and classification for the laser resistance of surgical drapes and/or patient protective covers - Part 1: Primary ignition and penetration (ISO 11810-1:2005)
    ISO 13938-1:1999 Textiles Bursting properties of fabrics Part 1: Hydraulic method for determination of bursting strength and bursting distension
    ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
    EN ISO 9073-12:2004 Textiles - Test methods for nonwovens - Part 12: Demand absorbency (ISO 9073-12:2002)
    EN 980:2008 Symbols for use in the labelling of medical devices
    EN ISO 11810-2:2009 Lasers and laser-related equipment - Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers - Part 2: Secondary ignition (ISO 11810-2:2007)
    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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