Sterilization of health care products. Ethylene oxide. Requirements for development, validation and routine control of a sterilization process for medical devices— 54 стр.
Sterilization of medical devices -- Microbiological methods -- Part 1: Determination of a population of microorganisms on products -- Technical Corrigendum 1— 1 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.
Medical devices utilizing animal tissues and their derivatives -- Part 3: Validation of the elimination and/ or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents— 30 стр.
Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Requirements for terminally sterilized medical devices— 12 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 health-care products. Ethylene oxide. Requirements for the development, validation and routine control of a sterilization process for medical devices— 94 стр.
Sterilization of health-care products. Ethylene oxide. Requirements for the development, validation and routine control of a sterilization process for medical devices— 102 стр.
