BS EN IEC 81001-5-1:2022 PDF Download

What is BS EN IEC 81001-5-1 - Security of health software life cycle process about?

BS EN IEC 81001 is a series on health software and health IT systems safety, effectiveness, and security. Health software is any software item or system used within a medical context, such as: reducing the paperwork and tracking patient activity. BS EN IEC 81001-5-1 defines the life cycle requirements for the development and maintenance of health software needed to support conformance to IEC 62443-4-1[11] – taking the specific needs for HEALTH SOFTWARE into account.

The set of processes, activities, and tasks described in BS EN IEC 81001-5-1 establishes a common framework for secure health software life cycle processes. an informal overview of activities for health software is shown in BS EN IEC 81001-5-1. The purpose is to increase the cybersecurity 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 of safety, effectiveness and security as discussed in ISO 81001-1[17].

Note: BS EN IEC 81001-5-1 excludes specification of accompanying documentation contents.

Who is BS EN IEC 81001-5-1 - Security of health software life cycle process for?

BS EN IEC 81001-5-1 on the security of health software life cycle process is useful for:

• Medical institutes
• Diagnostic laboratories
• Research and development facilities

Why should you use BS EN IEC 81001-5-1 - Security of health software life cycle process?

PROCESS standards for health software provide a specification of activities that will be performed by the manufacturer – including the software incorporated in medical devices –as a part of a development life cycle. the normative clauses of BS EN IEC 81001-5-1 are intended to provide minimum best practices for a secure software life cycle. local legislation and regulation are considered. normative clauses of this document specify activities that are the responsibility of the manufacturer. the health software life cycle can be part of an incorporating product project. some activities specified in this document depend on input and support from the product life cycle (for example defining specific criteria). examples include risk management, requirements, testing and post-release (after first placing health software on the market).

BS EN IEC 81001-5-1 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., healthcare delivery organizations, 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 ISO/IEC 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. Using BS EN IEC 81001-5-1 you can define the life cycle requirements for the development and maintenance of health software needed to support conformance to IEC 62443-4-1[11] – taking the specific needs for health software into account.