Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices— 50 стр.
Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment. General requirements for manufacturers, processors and products, test methods, performance requirements and performance levels— 26 стр.
Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment. General requirements for manufacturers, processors and products— 18 стр.
