ISO 20417:2021

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ISO 20417:2021 is an international standard that specifies the requirements for information provided by manufacturers of medical devices and accessories, ensuring users have the necessary information for safe and effective use. 

ISO 20417:2021 and EN 1041 are both standards for the information medical device manufacturers are required to supply along with their devices. This information may encompass instructions for use, technical descriptions, packaging, and marking, as well as any accompanying documentation.