Clinical investigation of medical devices for human subjects - Good clinical practice
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Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer
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Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
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Active implantable medical devices -- Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
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terilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices
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Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
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Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
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Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
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Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes
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Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
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Sterilization of health care products - Chemical indicators - Part 1: General requirements
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Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
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Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products
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Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
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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
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Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
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