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  • DIN EN ISO 22610:2015-12 (Draft)

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    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

    Available format(s):  Hardcopy, PDF

    Superseded date:  07-03-2021

    Language(s):  German

    Published date:  01-01-2015

    Publisher:  German Institute for Standardisation (Deutsches Institut für Normung)

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Principle
    5 Reagents and materials
    6 Apparatus
    7 Preparation of test samples and pieces
       7.1 Agar plates
       7.2 Carrier material
       7.3 Test specimen
    8 Procedure
       8.1 Preparation of donor
       8.2 Conditioning
       8.3 Test set-up
       8.4 Application of materials
       8.5 Test
    9 Test report
    10 Performance monitoring
       10.1 General
       10.2 With carbon paper
       10.3 With reference material
    Annex A (normative) Apparatus for testing resistance to
                          wet bacterial penetration
    Annex B (normative) Nutrient media
    Annex C (informative) Examples of how to use the test
                          results to characterize a barrier
                          material
    ANNEX ZA (informative) Relationship between this European
                           Standard and the Essential Requirements
                           of EU Directive 93/42/EEC
    Bibliography

    Abstract - (Show below) - (Hide below)

    This standard is included in DIN Handbook 475. Specifies a test method, with associated test, which is used to determine the resistance of a material to the penetration of bacteria, carried by a liquid, when subjected to mechanical rubbing.

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

    Comment Closes On
    Development Note DRAFT 2017 issued in May 2017. (05/2017)
    Document Type Draft
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Superseded

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

    DIN HDBK 475 : 2ED 2013
    VDI 2083 Blatt 18:2012-01 Cleanroom technology - Biocontamination control
    VDI 2083 Blatt 9.2:2017-01 Cleanroom technology - Consumables in the cleanroom

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

    EN 13795-3:2006+A1:2009 Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 3: Performance requirements and performance levels
    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
    ISO 13934-1:2013 Textiles — Tensile properties of fabrics — Part 1: Determination of maximum force and elongation at maximum force using the strip method
    DIN EN ISO 13485:2016-08 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
    ISO 6330:2012 Textiles Domestic washing and drying procedures for textile testing
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    DIN EN ISO 15797:2004-06 TEXTILES - INDUSTRIAL WASHING AND FINISHING PROCEDURES FOR TESTING OF WORKWEAR
    ISO 11607:2003 Packaging for terminally sterilized medical devices
    DIN EN ISO 13934-1:2013-08 TEXTILES - TENSILE PROPERTIES OF FABRICS - PART 1: DETERMINATION OF MAXIMUM FORCE AND ELONGATION AT MAXIMUM FORCE USING THE STRIP METHOD (ISO 13934-1:2013)
    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
    ISO 139:2005 Textiles Standard atmospheres for conditioning and testing
    ISO 15797:2002 Textiles Industrial washing and finishing procedures for testing of workwear
    ISO 13683:1997 Sterilization of health care products Requirements for validation and routine control of moist heat sterilization in health care facilities
    EN 554 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT
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