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 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 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.