Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices
€316.00
Sterilization of health care products. Radiation Guidance on dosimetric aspects development, validation and routine control
€355.00
Aseptic processing of health care products Isolator systems
€269.00
Sterilization of health care products. Dry heat. Requirements for the development, validation and routine control of a sterilization process for medical devices
€404.00
Aseptic processing of health care products General requirements
€374.00
Sterilization of health care products. Chemical indicators Type 2 and process challenge devices for use in performance testing small steam sterilizers
Sterilization of health care products. Biological indicators Method for validation a reduced incubation time biological indicator
€193.00
Sterilization of health care products. Biological and chemical indicators. Test equipment
Sterilization of health care products. Microbiological methods Tests sterility performed in the definition, validation and maintenance a sterilization process
Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6
Aseptic processing of health care products Sterilizing filtration
Sterilization of health care products. Chemical indicators General requirements
Sterilization of health care products. Biological indicators General requirements
Sterilization of health care products. Biological indicators for ethylene oxide sterilization processes
