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This part of ISO 11737 specifies requirements and provides guidance for the enumeration and 88 microbial characterization of the population of viable microorganisms on or in a health care product, 89 component, raw material or package. 90

NOTE The nature and extent of microbial characterization is dependent on the intended use of the bioburden 91 data. 92

This part of ISO 11737 does not specify requirements or provide guidance for the enumeration or 93 identification of viral, prion, or protozoan contaminants. This includes the removal and detection of the 94 causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy 95 and Creutzfeldt-Jakob disease. Guidance on inactivating viruses and prions can be found in ISO 22442-3, 96 ICH Q5A(R1) and ISO 13022. 97

This part of ISO 11737 does not specify requirements or provide guidance for the microbiological 98 monitoring of the environment in which health care products are manufactured.

This International Standard (IS) specifies fundamental characteristics to be measured of an engineered nanoparticles sample to determine the size, the chemical composition and the specific surface area of nanoparticles in powder form. This IS is applied to both particles that have a covering material on the surface of a core material and that do not have it. The IS also specifies measurement methods for determining each of these characteristics.

Excluded in this IS are characteristics that pertain to industrial applications of nanoparticles in powder form and detailed measurement protocols as well as characteristics related to health, safety, and environmental issues.