Sterilization of medical devices -- Microbiological methods -- Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process— 24 стр.
Sterilization of health care products -- Radiation -- Part 1: Requirements For development, validation and routine control of a sterilization process for medical devices— 44 стр.
Implants for surgery. Active implantable medical devices. General requirements for safety, marking and for information to be provided by the manufacturer— 64 стр.
Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Requirements for aseptically processed medical devices— 20 стр.
