ICS 07.100.10
Medical microbiology
Standards in This Category
EVS-EN ISO 11737-2:2020
Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)
LVS EN ISO 11737-1:2018
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018)
This standard establishes the fundamental microbiological protocols for assessing the bioburden on medical devices prior to sterilization. It outlines the systematic approach required to quantify the
LVS EN ISO 11737-2:2020
Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)
This document establishes comprehensive requirements for determining the sterility assurance level of medical devices during the definition, validation, and routine maintenance of sterilization
SM SR EN 1659:2012
In Vitro Diagnostic Medical Devices. Culture Media for Microbiology. Terms and Definitions
This document establishes a standardized framework for terminology and definitions specifically within the domain of microbiological culture media used for in vitro diagnostic systems. As the field
SM SR EN 12322:2010
In vitro diagnostic medical devices. Microbiology culture media. Performance criteria for culture media
This document establishes performance criteria for culture media utilized in microbiological procedures associated with in vitro diagnostic medical devices. It defines the necessary standards to
SM SR EN ISO 18153:2010
Medical devices for in vitro diagnostic testing. Measurement of biological sample volumes. Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials
This technical specification establishes a framework for ensuring metrological traceability in the measurement of enzyme catalytic concentrations assigned to calibrators and control materials within
SM SR EN ISO 11737-1:2010
Sterilization of medical devices. Microbiological methods. Part 1: Determination of the population of microorganisms on the product
This document outlines a specialized methodology for assessing microbial presence on medical devices intended for sterilization processes. It establishes rigorous procedures to determine the initial
SM GOST R ISO 18153:2009
In vitro diagnostic medical devices. Measurement of quantities in biological samples. Metrological traceability of values assigned for catalytic concentration of enzymes to calibrators and control materials
This technical document establishes a comprehensive framework for ensuring measurement traceability in the field of in vitro diagnostic medical devices. Specifically, it addresses the measurement of
MSZ EN ISO 11737-2:2010
MSZT
Sterilization of medical devices. Microbiological methods. Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2009)
MSZ EN ISO 11737-1:2006
MSZT
Sterilization of medical devices. Microbiological methods. Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006)
MSZ EN ISO 18153:2004
MSZT
In vitro diagnostic medical devices. Measurement of quantities in biological samples. Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003)
MSZ EN ISO 17511:2004
MSZT
In vitro diagnostic medical devices. Measurement of quantities in biological samples. Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003)
MSZ EN ISO 14729:2002
MSZT
Ophthalmic optics. Contact lens care products. Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses (ISO 14729:2001)
MSZ EN ISO 11737-2:2001
MSZT
Sterilization of medical devices. Microbiological methods. Part 2: Tests of sterility performed in the validation of a sterilization process (ISO 11737-2:1998)
This standard establishes the microbiological methods required for conducting sterility tests during the validation of sterilization processes for medical devices. It serves as a critical component
TCVN 8581-2:2010
TCVN
Sterilization of medical devices. Microbiological methods. Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
This document establishes the procedural framework for conducting sterility testing during the confirmation, validation, and routine maintenance of sterilization processes for medical devices.
TCVN 6848:2001
TCVN
Microbiology. General guidance for the enumeration of coliforms. Colony count technique
This technical specification outlines a standardized methodology for enumerating fecal coliforms through the colony count technique, providing essential guidance for microbiological analysis. The
TCVN 6846:2001
TCVN
Microbiology. General guidance for enumeration of presumptive. Escherichia coli. Most probable number technique
This document outlines a set of procedures for estimating Escherichia coli concentrations in various samples using the Most Probable Number method. The guidelines establish standardized protocols to
TCVN 6847:2001
TCVN
Microbioly. General guidance for the enumeration of Enterobacteriaceae without resuscitation. MPN technique and colony-count technique
This document outlines a standardized methodology within the field of microbiology, specifically focusing on the quantification of Enterobacteriaceae. It provides a comprehensive framework for two
MSZ 1507:1993
MSZT
Haemodialysing liquid and water for preparing of haemodialysing liquid
This document establishes comprehensive requirements for the composition and purity of dialysis solutions used in extracorporeal blood purification procedures. It specifically addresses the
MSZ 6891:1989
MSZT
Enumeration of living aerobic micro-organisms in bull sperm
This document establishes a standardized procedure for determining the concentration of viable aerobic microorganisms within semen samples. It provides detailed guidelines for sample collection,