Sterilization of health care products -- Radiation -- Part 1: Requirements For development, validation and routine control of a sterilization process for medical devices— 44 стр.
Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices— 48 стр.
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 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.
Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices— 54 стр.
Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Requirements for aseptically processed medical devices— 20 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— 24 стр.
Sterilization of medical devices. Estimation of the population of micro-organisms on product, Guide to the methods for validation of microbiological techniques— 14 стр.
