ABSTRACT

1.4. Microbiological testing is taken to include sterility testing, detection, isolation, enumeration, and identification of micro-organisms (viruses, bacteria, fungi, and protozoa) and their metabolites in different materials and products, or any kind of assay using micro-organisms as part of a detection system as well as the use of micro-organisms for ecological testing. It follows that some of the guidance in this document, e.g. on laboratory environment, will need to be interpreted accordingly. This document can also provide guidance to laboratories using techniques in areas related to microbiology, such as biochemistry, molecular biology, and cell culture, although there may be additional requirements for such laboratories.