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
Hardcopy , PDF
English
01-04-2019
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.
Committee |
E 35
|
DocumentType |
Standard Practice
|
Pages |
6
|
ProductNote |
THIS STANDARD ALSO REFERS TO 21 CFR, Part 58, 40 CFR, Part 160
|
PublisherName |
American Society for Testing and Materials
|
Status |
Current
|
Supersedes |
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.
ASTM E 3011 : 2015 | Standard Test Method for In vitro production of <emph type="ital">Clostridium Difficile</emph > Spores |
ASTM E 2839 : 2018 | Standard Practice for Production and Storage of Spores of <emph type="bdit">C. difficile</emph > for Use in Efficacy Evaluation of Antimicrobial Agents |
ASTM E 2756 : 2024 | Standard Terminology Relating to Antimicrobial and Antiviral Agents |
ASTM D 1129 : 2003 | Standard Terminology Relating to Water |
ASTM E 2756 : 2024 : REV A : EDT 1 | Standard Terminology Relating to Antimicrobial and Antiviral Agents |
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 E 2197 : 2024 | Standard Quantitative Disk Carrier Test Method for Determining Bactericidal, Virucidal, Fungicidal, Mycobactericidal, and Sporicidal Activities of Chemicals |
ASTM D 1129 : 2006 | Standard Terminology Relating to Water |
ASTM E 2756 : 2024 : REV A | Standard Terminology Relating to Antimicrobial and Antiviral Agents |
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 : 2024 | 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 <i>Clostridium difficile</i> 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 <emph type="bdit">C. difficile</emph > for Use in Efficacy Evaluation of Antimicrobial Agents |
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