Các hướng dẫn BS EN ISO 13408 & 11138

 

 

BS EN ISO 13408 - Aseptic processing of health care products

Part 1: Aseptic processing of health care products. General requirements

Part 2: Aseptic processing of health care products. Filtration

Part 3: Aseptic processing of health care products. Lyophilization

Part 4: Aseptic processing of health care products. Clean-in-place technologies

Part 5: Aseptic processing of health care products. Sterilization in place

Part 6: Aseptic processing of health care products. Isolator systems

Part 7: Aseptic processing of health care products. Alternative processes for medical devices and combination products

BS EN ISO 13408 - Sterilization of health care products

Part 1: Biological indicators - General requirements

Part 2: Biological indicators for ethylene oxide sterilization processes

Part 3: Biological indicators for moist heat sterilization processes

Part 4: Biological indicators for dry heat sterilization processes

Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes

Part 7: Biological indicators - Guidance for the selection, use and interpretation of results

Part 8: Biological indicators - Method for validation of a reduced incubation time for a biological indicator