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. Biological indicators. Biological indicators for low-temperature steam and formaldehyde sterilization processes— 16 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.
Medical devices. Recognized essential principles of safety and performance of medical devices. General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards— 50 стр.
Medical devices. Recognized essential principles of safety and performance of medical devices. General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards— 60 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.
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 medical devices. Microbiological methods. Tests of sterility performed in the definition, validation and maintenance of a sterilization process— 28 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. Moist heat. Guidance on the designation of a medical device to a product family and processing category for steam sterilization— 60 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.
Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11135-1:2007)
