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 health care products. Ethylene oxide. Requirements for development, validation and routine control of a sterilization process for medical devices— 54 стр.
Sterilization of health care products. Radiation. Requirements for development, validation and routine control of a sterilization process for medical devices— 50 стр.
Sterilization of health care products. Moist heat. Requirements for the development, validation and routine control of a sterilization process for medical devices— 52 стр.
Sterilization of health care products. Radiation. Requirements for development, validation and routine control of a sterilization process for medical devices— 52 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.
Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6— 32 стр.
Medical devices utilizing animal tissues and their derivatives. Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes— 24 стр.
BS EN ISO 14160. Sterilization of health care products. Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives. Requirements for characterization, development, validation and routine control of a sterilization process for medical devices— 48 стр.
Sterilization of health care products. General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices— 52 стр.
Sterilization of health care products. Dry heat. Requirements for the development, validation and routine control of a sterilization process for medical devices— 72 стр.
Sterilization of health care products. Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives. Requirements for characterization, development, validation and routine control of a sterilization process for medical devices— 44 стр.
BS EN ISO 10993-18. Biological evaluation of medical devices. Part 18. Chemical characterization of medical device materials within a risk management process— 71 стр.
