Documents
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ISO 7207:2020 Implants for surgery – Components for partial and total knee joint prostheses – Part 2: Articulating surfaces made of metal, ceramic and plastics materials – Amendment 2
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ISO 18241:2019 Cardiovascular implants and extracorporeal systems – Cardiopulmonary bypass systems – Venous bubble traps – Amendment 1: Connectors
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ISO 18192:2018 Implants for surgery – Wear of total intervertebral spinal disc prostheses – Part 1: Loading and displacement parameters for wear testing and corresponding environmental conditions for test – Amendment 1
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ISO 14243:2020 Implants for surgery – Wear of total knee-joint prostheses – Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test – Amendment 1
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ISO 11137:2022 Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose – Amendment 1
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ISO 11607:2023 Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems – Amendment 1: Application of risk management
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ISO 10993:2022 Biological evaluation of medical devices – Part 18: Chemical characterization of medical device materials within a risk management process – Amendment 1: Determination of the uncertainty factor
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ISO 14496:2022 Information technology – Coding of audio-visual objects – Part 30: Timed text and other visual overlays in ISO base media file format – Amendment 1: Timing improvements
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ISO 10524:2023 Pressure regulators for use with medical gases – Part 1: Pressure regulators and pressure regulators with flow-metering devices – Amendment 1
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