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About This Item
Full Description
NOTE 1 The nature and extent of microbial characterization is dependent on the intended use of bioburden data.
NOTE 2 See Annex A for guidance on Clauses 1 to 9.
ISO 11737-1:2018 does not apply to the enumeration or identification of viral, prion or protozoan contaminants. This includes the removal and detection of the causative agents of spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease.
NOTE 3 Guidance on inactivating viruses and prions can be found in ISO 22442?3, ICH Q5A(R1) and ISO 13022.
ISO 11737-1:2018 does not apply to the microbiological monitoring of the environment in which health care products are manufactured.
Document History
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ISO 11737-1:2018
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Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products- Most Recent
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ISO 11737-1:2006
Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products- Historical Version
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ISO 11737-1:1995
Sterilization of medical devices -- Microbiological methods -- Part 1: Estimation of population of microorganisms on products- Historical Version