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  • 17/30358658 DC : 0

    NA Status of Standard is Unknown

    BS EN 13795-1 - SURGICAL CLOTHING AND DRAPES - REQUIREMENTS AND TEST METHODS - PART 1: SURGICAL DRAPES AND GOWNS

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date: 

    Publisher:  British Standards Institution

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

    European foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Performance requirements
    5 Manufacturing and processing requirements
     and documentation
    6 Information to be supplied with the product
    Annex A (normative) - Testing
    Annex B (informative) - Rationales
    Annex C (informative) - Information on further characteristics
    Annex D (informative) - Environmental aspects
    Annex E (informative) - Guidance to users for selecting products
    Annex ZA (informative) - Relationship between this European
             standard and the essential requirements of Directive
             93/42/EEC [OJ L 169] aimed to be covered
    Bibliography

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

    Comment Closes On
    Committee CH/205/1
    Document Type Draft
    Publisher British Standards Institution
    Status NA

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

    ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
    EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
    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 11810:2015 Lasers and laser-related equipment Test method and classification for the laser resistance of surgical drapes and/or patient protective covers Primary ignition, penetration, flame spread and secondary ignition
    EN ISO 10993-10:2013 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
    EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
    ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
    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
    EN ISO 11810:2015 Lasers and laser-related equipment - Test method and classification for the laser resistance of surgical drapes and/or patient protective covers - Primary ignition, penetration, flame spread and secondary ignition (ISO 11810:2015)
    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 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    EN 62366 : 2008 AMD 1 2015 MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007/A1:2014)
    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 9073-6:2003 Textiles - Test methods for nonwovens - Part 6: Absorption (ISO 9073-6:2000)
    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)
    ISO 15797:2002 Textiles Industrial washing and finishing procedures for testing of workwear
    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)
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    ISO 9073-6:2000 Textiles — Test methods for nonwovens — Part 6: Absorption
    EN ISO 10993-1:2009/AC:2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)
    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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