ISO/TC 209 Biocontamination Standards: ISO 14698-1 and -2

The ISO 14698 Series features two International Standards on Biocontamination control. ISO 14698-1, Cleanrooms and associated controlled environments--Biocontamination control, Part 1: General principles and methods, and ISO 14698-2, Cleanrooms and associated controlled environments--Biocontamination control, Part 2: Evaluation and interpretation of biocontamination data.

Scope of ISO/DIS 14698-1
Part 1, General principles, describes the principles and basic methodology for a formal system to assess and control biocontamination, where cleanroom technology is applied, in order that biocontamination in zones at risk can be monitored in a reproducible way and appropriate control measures can be selected. In zones of low or negligible risk this standard may be used as a source of information.

Scope of ISO/DIS 14698-2

The second part, titled Part 2: Evaluation and interpretation of biocontamination data, gives guidance on basic principles and methodological requirements for all microbiological data evaluation, and the estimation of biocontamination data obtained from sampling for viable particles in zones at risk, as specified by the system selected. This is not intended for testing the performance of microbiological counting techniques of determining viable units.