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Aseptic processing of health care products — Part 2: Sterilizing filtration
90.93 Standard confirmed
Aseptic processing of health care products — Part 3: Lyophilization
90.93 Standard confirmed
Aseptic processing of health care products — Part 4: Clean-in-place technologies
90.93 Standard confirmed
Aseptic processing of health care products — Part 5: Sterilization in place
90.93 Standard confirmed
Aseptic processing of health care products — Part 6: Isolator systems
60.60 Standard published
Aseptic processing of health care products — Part 7: Alternative processes for medical devices and combination products
90.93 Standard confirmed
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
60.60 Standard published
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
90.93 Standard confirmed
Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results
90.93 Standard confirmed
Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices
60.60 Standard published
Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 2: Non-critical medical devices
60.60 Standard published
Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devices
60.60 Standard published
Manufacture of cell-based health care products — Control of microbial risks during processing
90.93 Standard confirmed
Manufacture of cell-based health care products — Control of microbial risks during processing — Amendment 1
60.60 Standard published
Sterilization of health care products — Biological and chemical indicators — Test equipment
90.93 Standard confirmed
Sterilization of health care products — Dry heat — Requirements for the development, validation and routine control of a sterilization process for medical devices
90.93 Standard confirmed
Sterilization of health care products — Low temperature vaporized hydrogen peroxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
60.60 Standard published
Sterilization of health care products — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices
90.93 Standard confirmed