• ASTM E 2895 : 2019

    Current The latest, up-to-date edition.

    Standard Practice for Producing High Titers of Viable and Semi-Purified Spores of Clostridium difficile using a Liquid Medium

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-04-2019

    Publisher:  American Society for Testing and Materials

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    Abstract - (Show below) - (Hide below)

    This practice describes the production and semipurification ofC. difficilespores (also called endospores) primarily for use in testing the sporicidal activities of environmental surface disinfectants (Test MethodsE2111andE2197); such spores can also be used to study their structure, chemistry and germination.

    Scope - (Show below) - (Hide below)

    1.1This practice describes the production and semipurification of C. difficile spores (also called endospores) primarily for use in testing the sporicidal activities of environmental surface disinfectants (Test Methods E2111and E2197); such spores can also be used to study their structure, chemistry and germination.

    1.2While the practice described is based on the use of 500-mL volumes of the liquid culture medium in an anaerobic incubator, anaerobic jars with smaller volumes of the same medium can also be used.

    1.3It is the responsibility of the investigator to determine whether Good Laboratory Practice (GLP) regulations are required and to follow them when appropriate (40 CFR, Part 160 for EPA submissions and 21 CFR; Part 58 for FDA submissions).

    1.4Warning—This standard may involve hazardous materials, chemicals, and microorganisms and should be performed only by persons with formal training in microbiology.

    1.5The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

    1.6This 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

    1.7This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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

    Committee E 35
    Document Type Standard Practice
    Product Note THIS STANDARD ALSO REFERS TO 21 CFR, Part 58, 40 CFR, Part 160
    Publisher American Society for Testing and Materials
    Status Current
    Supersedes

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

    ASTM E 3011 : 2015 Standard Test Method for In vitro production of Clostridium Difficile Spores

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

    ASTM E 2839 : 2018 Standard Practice for Production and Storage of Spores of C. difficile for Use in Efficacy Evaluation of Antimicrobial Agents
    ASTM D 1129 : 2003 Standard Terminology Relating to Water
    ASTM D 1129 : 2013 Standard Terminology Relating to Water
    ASTM D 1129 : 2013 : R2020 Standard Terminology Relating to Water
    ASTM E 2197 : 2002 Standard Quantitative Disk Carrier Test Method for Determining the Bactericidal, Virucidal, Fungicidal, Mycobactericidal and Sporicidal Activities of Liquid Chemical Germicides
    ASTM D 1129 : 2013 : R2020 : EDT 2 Standard Terminology Relating to Water
    ASTM D 1129 : 2006 Standard Terminology Relating to Water
    ASTM E 2756 : 2019 Standard Terminology Relating to Antimicrobial and Antiviral Agents
    ASTM D 1129 : 2013 : R2020 : EDT 1 Standard Terminology Relating to Water
    ASTM D 1129 : 1999 : REV A Standard Terminology Relating to Water
    ASTM D 1129 : 2006 : REV A Standard Terminology Relating to Water
    ASTM D 1129 : 2003 : REV A Standard Terminology Relating to Water
    ASTM D 1129 : 2002 Standard Terminology Relating to Water
    ASTM E 2111 : 2012 Standard Quantitative Carrier Test Method to Evaluate the Bactericidal, Fungicidal, Mycobactericidal, and Sporicidal Potencies of Liquid Chemicals
    ASTM E 2756 : 2010 Standard Terminology Relating to Antimicrobial and Antiviral Agents
    ASTM E 2839 : 2011 Standard Test Method for Production of Clostridium difficile Spores for Use in Efficacy Evaluation of Antimicrobial Agents
    ASTM E 2111 : 2000 Standard Quantitative Carrier Test Method To Evaluate the Bactericidal, Fungicidal, Mycobactericidal and Sporicidal Potencies of Liquid Chemical Germicides
    ASTM E 2197 : 2017 Standard Quantitative Disk Carrier Test Method for Determining Bactericidal, Virucidal, Fungicidal, Mycobactericidal, and Sporicidal Activities of Chemicals
    ASTM D 1129 : 2004 Standard Terminology Relating to Water
    ASTM D 1129 : 2002 : REV A Standard Terminology Relating to Water
    ASTM E 2756 : 2018 Standard Terminology Relating to Antimicrobial and Antiviral Agents
    ASTM E 2197 : 2017 : EDT 1 Standard Quantitative Disk Carrier Test Method for Determining Bactericidal, Virucidal, Fungicidal, Mycobactericidal, and Sporicidal Activities of Chemicals
    ASTM E 2111 : 2005 Standard Quantitative Carrier Test Method to Evaluate the Bactericidal, Fungicidal, Mycobactericidal, and Sporicidal Potencies of Liquid Chemical Microbicides
    ASTM D 1129 : 2010 Standard Terminology Relating to Water
    ASTM D 1129 : 2006 : REV A : EDT 1 Standard Terminology Relating to Water
    ASTM E 2197 : 2011 Standard Quantitative Disk Carrier Test Method for Determining the Bactericidal, Virucidal, Fungicidal, Mycobactericidal and Sporicidal Activities of Liquid Chemical Germicides
    ASTM D 1129 : 2001 Standard Terminology Relating to Water
    ASTM D 1129 : 2004 : EDT 1 Standard Terminology Relating to Water
    ASTM E 2111 : 2012 : R2018 Standard Quantitative Carrier Test Method to Evaluate the Bactericidal, Fungicidal, Mycobactericidal, and Sporicidal Potencies of Liquid Chemicals
    ASTM E 2839 : 2021 Standard Practice for Production and Storage of Spores of C. difficile for Use in Efficacy Evaluation of Antimicrobial Agents
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