Most Relevant Norms and Associations

Internet linkes to ISO

ISO (International Organization for Standardization)

ISO 10648 (Containment enclosure, Part 1 Design principles, Part 2 Classification according to leak tightness and associated checking method)
ISO 11135 (Sterilization of health care products, Part 1 Req. for developm., validation and routine control of a sterilization process for medical devices)
ISO 13408-6 (Aseptic processing of health care products)
ISO 14161 (Sterilization of health care products - Biological indicators)
ISO 14644 (Cleanrooms and associated controlled environments)
ISO 14644-1 Classification of Air Cleanliness
ISO 14644-2 Cleanroom Testing for Compliance
ISO 14644-3 Methods for Evaluating and Measuring Cleanrooms and Associated Controlled Environments
ISO 14644-4 Cleanroom Design and Construction
ISO 14644-5 Cleanroom Operations
ISO 14644-6 Terms, Definitions and Units
ISO 14644-7 Enhanced Clean Devices
ISO 14644-8 Molecular Contamination
ISO 14644-9 Surface Cleanliness by Particle Concentration
ISO 14644-10 Surface Cleanliness by Chemical Concentrations
ISO 14698 (Biocontamination control)
ISO 14698-1 General Principles and Methods
ISO 14698-2 Evaluation and Interpretation of Data
ISO 14698-3 Methodology for Measuring Efficiency of Cleaning Inert Surfaces
ISO 14971 (Medical devices - Application of risk management to medical devices)

VDI 2083 Cleanroom technology Barrier systems (isolators, mini-environments, separative devices)