PD CEN ISO/TS 82304-2:2021 PDF

What is  ISO/TS 82304-2 about?

ISO/TS 82304-2 is the second part of the multiple series that provides quality requirements for health apps and defines a health app quality label in order to visualize the quality and reliability of health apps. ISO/TS 82304-2 is applicable to health apps, which are a special form of health software. It covers the entire life cycle of health apps. Note: Health apps can be subject to national legislation, such as for medical devices. See Annex C for additional details on the scope. Outside the scope of ISO/TS 82304-2 are guidelines to comply with the medical device regulation. ISO/TS 82304-2 ...