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  • ASTM F 2407 : 2006 : R2013 : EDT 1

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities

    Available format(s):  Hardcopy, PDF

    Superseded date:  07-10-2020

    Language(s):  English

    Published date:  15-05-2013

    Publisher:  American Society for Testing and Materials

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    Abstract - (Show below) - (Hide below)

    CONTAINED IN VOL. 11.03, 2014 Defines requirements for the performance, documentation, and labeling of surgical gowns used in the healthcare facilities.

    Scope - (Show below) - (Hide below)

    1.1This specification establishes requirements for the performance, documentation, and labeling of surgical gowns used in the healthcare facilities. Four levels of barrier properties for surgical gowns are specified in AAMI PB70 and are included in this specification for reference purposes.

    Note 1—Some properties require minimum performance and others are for documentation only.
    Note 2—AAMI PB70 evaluates the barrier properties of surgical gown fabrics using water only in Levels 1, 2, and 3. Since surgical gowns are exposed to blood and other fluids with different surface tensions, the performance of additional testing to identify the barrier levels to simulated biological fluids is required for a Level 4 gown.

    1.2This specification does not cover all the requirements that a healthcare facility deems necessary to select a product, nor does it address criteria for evaluating experimental products.

    1.3This specification is not intended to serve as a detailed manufacturing or purchase specification, but can be referenced in purchase specifications as the basis for selecting test requirements.

    1.4The values stated in SI units or in other units shall be regarded separately as standard. The values stated in each system must be used independently of the other, without combining values in any way.

    1.5This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

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

    Committee F 23
    Document Type Standard
    Product Note Reconfirmed EDT 1
    Publisher American Society for Testing and Materials
    Status Superseded
    Superseded By
    Supersedes

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

    ASTM F 1494 : 2014 Standard Terminology Relating to Protective Clothing
    ASTM F 3352 : 2019 Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities

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

    ASTM D 5733 : 1999 Standard Test Method for Tearing Strength of Nonwoven Fabrics by the Trapezoid Procedure (Withdrawn 2008)
    ASTM F 1868 : 2009 Standard Test Method for Thermal and Evaporative Resistance of Clothing Materials Using a Sweating Hot Plate
    ASTM F 1671 : 1997 : REV B Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System
    ASTM F 1494 : 2014 Standard Terminology Relating to Protective Clothing
    ASTM D 5034 : 2009 Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test)
    ASTM D 6701 : 2016 Standard Test Method for Determining Water Vapor Transmission Rates Through Nonwoven and Plastic Barriers
    ASTM F 1494 : 2013 Standard Terminology Relating to Protective Clothing
    ISO 11135:2014 Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
    ASTM D 5587 : 2007 : REV A Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure
    ASTM D 1776 : 1998 : EDT 1 Standard Practice for Conditioning and Testing Textiles
    ISO 3951:1989 Sampling procedures and charts for inspection by variables for percent nonconforming
    AAMI TIR 11 : 2005 SELECTION AND USE OF PROTECTIVE APPAREL AND SURGICAL DRAPES IN HEALTH CARE FACILITIES
    ASTM F 1494 : 2003 Standard Terminology Relating to Protective Clothing
    ASTM D 1776 : 1967 : EDT 1 Standard Method Of Conditioning Textiles And Textile Products For Testing
    ASTM D 5587 : 2015 : REDLINE TEST METHOD FOR TEARING STRENGTH OF FABRICS BY TRAPEZOID PROCEDURE
    ASTM D 5034 : 2009 : R2013 Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test)
    CFR 21(PTS800-1299) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
    ASTM D 5034 : 1995 : R2001 Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test)
    CFR 16(PTS1000-END) : 0 COMMERCIAL PRACTICES - FEDERAL TRADE COMMISSION - CONSUMER PRODUCT SAFETY COMMISSION
    ASTM D 6701 : 2001 Standard Test Method for Determining Water Vapor Transmission Rates Through Nonwoven and Plastic Barriers (Withdrawn 2008)
    ASTM F 1868 : 2017 Standard Test Method for Thermal and Evaporative Resistance of Clothing Materials Using a Sweating Hot Plate
    ASTM D 1683 : 2004 Standard Test Method for Failure in Sewn Seams of Woven Apparel Fabrics
    ASTM D 5587 : 2007 : REV A : EDT 1 Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure
    AAMI BE78 : 2002 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND DELAYED TYPE HYPERSENSITIVITY
    ASTM F 1868 : 2012 Standard Test Method for Thermal and Evaporative Resistance of Clothing Materials Using a Sweating Hot Plate
    ASTM D 1776 : 2004 Standard Practice for Conditioning and Testing Textiles
    ASTM F 1494 : 1999 Standard Terminology Relating to Protective Clothing
    ASTM D 5587 : 2014 Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure
    ASTM D 1776 : 2008 : EDT 1 Standard Practice for Conditioning and Testing Textiles
    AAMI ST65:2008(R2018) PROCESSING OF REUSABLE SURGICAL TEXTILES FOR USE IN HEALTH CARE FACILITIES
    ASTM D 1776 : 2008 Standard Practice for Conditioning and Testing Textiles
    ASTM D 5587 : 2003 Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure
    ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
    ASTM F 1671 : 2007 Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System
    ASTM F 1868 : 1998 Standard Test Method for Thermal and Evaporative Resistance of Clothing Materials Using a Sweating Hot Plate
    ASTM F 1868 : 2002 Standard Test Method for Thermal and Evaporative Resistance of Clothing Materials Using a Sweating Hot Plate
    CFR 29(PT1910.1000 TO END) : 0 LABOR - OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR
    ASTM F 1671 : 2003 Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System
    ASTM D 5587 : 2008 Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure
    ASTM D 5034 : 2008 Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test)
    ASTM D 5587 : 1996 Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure
    ISO 9073-10:2003 Textiles Test methods for nonwovens Part 10: Lint and other particles generation in the dry state
    ASTM F 1494 : 2003 : R2011 Standard Terminology Relating to Protective Clothing
    ASTM F 1494 : 2001 Standard Terminology Relating to Protective Clothing
    ASTM D 1683 : 2007 Standard Test Method for Failure in Sewn Seams of Woven Apparel Fabrics
    ASTM D 5034 : 2009 : R2017 Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test)
    ISO 11134:1994 Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization
    ASTM F 1494 : 2014 : REDLINE Standard Terminology Relating to Protective Clothing
    ASTM D 5587 : 2005 Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure
    ASTM F 1868 : 2017 : REDLINE Standard Test Method for Thermal and Evaporative Resistance of Clothing Materials Using a Sweating Hot Plate
    ISO 11137:1995 Sterilization of health care products Requirements for validation and routine control Radiation sterilization
    ASTM D 5034 : 1995 Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test)
    ANSI/AAMI PB70:2012 LIQUID BARRIER PERFORMANCE AND CLASSIFICATION OF PROTECTIVE APPAREL AND DRAPES INTENDED FOR USE IN HEALTH CARE FACILITIES
    ASTM D 5587 : 2015 Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure
    ISO 13683:1997 Sterilization of health care products Requirements for validation and routine control of moist heat sterilization in health care facilities
    ASTM D 5587 : 2015 : R2019 Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure
    ASTM D 5587 : 2007 Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure
    ASTM F 1868 : 2014 Standard Test Method for Thermal and Evaporative Resistance of Clothing Materials Using a Sweating Hot Plate
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