Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices
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Standard Test Method to Determine Efficacy of Disinfection Processes for Reusable Medical Devices (Simulated Use Test) (Withdrawn 2023)
Sterilization of health care products. Chemical indicators Class 2 as an alternative to the Bowie and Dick-type test for detection steam penetration
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Sterilization of health care products. Chemical indicators Class 2 for Bowie and Dick-type air removal tests
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Sterilization of health care products. Chemical indicators. Guidance for selection, use and interpretation of results
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Sterilization of health care products. Moist heat Guidance on the application ISO 17665-1
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Aseptic processing of health care products Isolator systems
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Sterilization of health care products. Microbiological methods Tests sterility performed in the definition, validation and maintenance a sterilization process
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
Sterilization of health care products. Radiation Requirements for development, validation and routine control a sterilization process medical devices
Traditional Chinese medicine. Infection control for acupuncture treatment
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Sterilization of health care products. Chemical indicators Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
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
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
Sterilization of medical devices. Requirements for devices to be designated "STERILE" Part 1. terminally sterilized