Sterilization of medical devices -- Low temperature steam and formaldehyde -- Requirements for development, validation and routine control of a sterilization process for medical devices— 48 стр.
Sterilization of health care products -- Low temperature steam and formaldehyde -- Requirements for development, validation and routine control of a sterilization process for medical devices— 50 стр.
Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices. Part 1: Devices that require cleaning followed by disinfection and/or sterilization— 32 стр.
Sterilization of health care products. Biological indicators. Biological indicators for low-temperature steam and formaldehyde sterilization processes— 16 стр.
Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Requirements for aseptically processed medical devices— 20 стр.
Medical devices. Recognized essential principles of safety and performance of medical devices. General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards— 60 стр.
Sterilization of health care products -- Low temperature steam and formaldehyde -- Requirements for development, validation and routine control of a sterilization process for medical devices— 50 стр.
