prEN IEC 81001-5-1:2020

1.1 Purpose This document defines the LIFE CYCLE requirements for development and maintenance of HEALTH SOFTWARE needed to support conformity to IEC 62443-4-1 - taking the specific needs for HEALTH SOFTWARE into account. The set of PROCESSES, ACTIVITIES, and TASKS described in this document establishes a common framework for secure HEALTH SOFTWARE LIFE CYCLE PROCESSES. [Fig. 1] The purpose is to increase the information SECURITY of HEALTH SOFTWARE by establishing certain ACTIVITIES and TASKS in the HEALTH SOFTWARE LIFE CYCLE PROCESSES and also by increasing the SECURITY of SOFTWARE LIFE CYCLE PROCESSES themselves. It is important to maintain an appropriate balance of the key properties SAFETY, effectiveness and SECURITY as discussed in IEC 81001-1. This document excludes specification of ACCOMPANYING DOCUMENTATION contents. 1.2 Field of application This document applies to the development and maintenance of HEALTH SOFTWARE by a MANUFACTURER, but recognizes the critical importance of bi-lateral communication with organizations (e.g. HDOs) who have SECURITY responsibilities for the HEALTH SOFTWARE and the systems it is incorporated into, once the software has been developed and released. The IEC/ISO 81001-5 series of standards (for which this is part 1, is therefore being designed to include future parts addressing SECURITY that apply to the implementation, operations and use phases of the LIFE CYCLE for organizations such as HDOs. Medical device software is a subset of HEALTH SOFTWARE. Therefore, this document applies to: − Software as part of a medical device; − Software as part of hardware specifically intended for health use; − Software as a medical device (SaMD); and − Software-only PRODUCT for other health use. Note: In this document, the scope of software considered part of the LIFE CYCLE ACTIVITIES for secure HEALTH SOFTWARE is larger and includes more software (drivers, platforms, operating systems) than for SAFETY, because for SECURITY the focus will be on any use including foreseeable unauthorized access rather than just the INTENDED USE. [Fig. 2] 1.3 Conformance HEALTH SOFTWARE conformance with this document is defined as implementing all of the PROCESSES, ACTIVITIES, and TASKS identified in the normative parts of this document - with the exception of Annex F. Conformance of TRANSITIONAL HEALTH SOFTWARE with Annex F of this document is defined as only implementing the PROCESSES, ACTIVITIES, and TASKS identified in Annex F of this document. Conformance is determined by inspection and establishing traceability of the PROCESSES, ACTIVITIES and TASKS required. The quality management system may be implemented according to ISO 13485 or other equivalent quality management system standards. IEC 62304 specifies ACTIVITIES, based on the software SAFETY classification. The required ACTIVITIES are indicated in the normative text of IEC 62304 as "[Class A, B, C]", "[Class B, C]" or "[Class C]", indicating that they are required selectively depending on the classification of the software to which they apply. The requirements in this document have a special focus on information SECURITY and therefore do not follow the concept of SAFETY classes. For conformity to this document the selection of ACTIVITIES is independent of SAFETY classes. Implementing the PROCESSES, ACTIVITIES and TASKS specified in this document is sufficient to implement the PROCESS requirements of IEC 62443-4-1. MANUFACTURERS may implement the specifications for Annex E in order to achieve full conformity to IEC 62443-4-1. This document requires establishing one or more PROCESSES that comprise of identified ACTIVITIES. The LIFE CYCLE PROCESSES shall implement these ACTIVITIES. None of the requirements in this document requires to implement these ACTIVITIES as one single PROCESS or as separate PROCESSES. The ACTIVITIES specified in this document will typically be part of an existing LIFE CYCLE PROCESS.