prEN IEC 62304:2021

1.1 * Purpose This document defines the development and maintenance life cycle requirements for HEALTH SOFTWARE. The set of PROCESSES, ACTIVITIES, and TASKS described in this document establishes a common framework for HEALTH SOFTWARE life cycle PROCESSES. 1.2 * Field of application This document applies to the development and maintenance of HEALTH SOFTWARE by a MANUFACTURER. MEDICAL DEVICE SOFTWARE is a subset of HEALTH SOFTWARE (see Figure 2). Therefore, this document applies to: - software as part of a MEDICAL DEVICE; - software as part of specific health hardware; - software as a MEDICAL DEVICE (SaMD); - software-only product for other health use. Figure 2 provides a graphical representation of the health software this document applies to. [Figure 2] NOTE 1 Examples of HEALTH SOFTWARE include the following: 1) software as a part of a MEDICAL DEVICE: software that is an integral part of a device such as an infusion pump or dialysis machine. 2) software as part of specific health hardware: patient wristband printer software, healthcare scanner software, health app on specific wearable hardware (i.e. watch, wristband, chestband). 3) software as a MEDICAL DEVICE (SaMD): software that is itself a MEDICAL DEVICE, such as a software application that performs diagnostic image analysis for making treatment decisions. A definition of software as a MEDICAL DEVICE is provided in [46] 1. 4) software-only product for other health use: hospital information systems, electronic health records, electronic medical records, mobile applications running on devices without physiologic sensors or detectors, software as a service, i.e. software executed in an external environment, providing calculation-results that fulfil the definition of a MEDICAL DEVICE. NOTE 2 This document can be used in the development and maintenance of HEALTH SOFTWARE. Before any type of software can be placed into service, activities are necessary before the software product is integrated into the SYSTEM. These SYSTEM activities are not covered by this document (see Figure 1), but can be found in related product standards (e.g., IEC 60601-1 [1] or IEC 82304-1 [15]). For software as a MEDICAL DEVICE (SaMD) additional guidance on ACTIVITIES at a system level (e.g. clinical EVALUATION) can be found in regulatory authority guidance documents. [...]