PREN 17141 : DRAFT 2017

European foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Establishment of control requirements
5 Demonstrating control
6 Metrology
7 Training
Annex A (informative) - Guidance for life science
        pharma/biopharma applications
Annex B (informative) - Guidance for life science
        medical device applications
Annex C (informative) - Guidance for
        healthcare/hospital applications
Annex D (informative) - Guidance for food
        applications
Annex E (informative) - Evolving metrology of
        biocontamination control
Annex F (informative) - Guidance on determining
        airborne microbiological levels
Annex G (informative) - Guidance on verifying
        samplers used for evaluating airborne
        microbiological levels
Annex H (informative) - Guidance on determining
        microbiological contamination of surfaces
Annex I (informative) - Guidance on determining
        microbiological contamination of textiles
Annex J (informative) - Guidance on verifying
        laundering processes
Annex K (informative) - Guidance on training
Annex L (informative) - Typical sources of
        microbiological contamination
Bibliography

Describes the principles and basic methodology of a formal system of biocontamination control in Cleanrooms and associated controlled environments.