DIN EN 17141:2018-09

This European Standard establishes the principles and basic methodology of a formal system of biocontamination control in Cleanrooms and associated controlled environments. These principles are based on establishing control and then on demonstrating control. This standard specifies the methods required for assessing risk monitoring risk zones in a consistent way and for applying control measures appropriate to the degree of risk involved. It will also give guidance on the assessment and verification of microbiological sampling devices, with the aim of helping users standardize their monitoring so that results from one facility to another can be compared. Within this standard, only microbiological hazards are addressed. There is specific guidance given on common applications, including Food, Hospitals and Life Sciences (Pharma/Biopharma and Medical Devices).