scope:

Purpose

This standard defines the life cycle requirements for MEDICAL DEVICE SOFTWARE. The set of PROCESSES, ACTIVITIES, and TASKS described in this standard establishes a common framework for MEDICAL DEVICE SOFTWARE life cycle PROCESSES.

Field of application

This standard applies to the development and maintenance of MEDICAL DEVICE SOFTWARE.

This standard applies to the development and maintenance of MEDICAL DEVICE SOFTWARE when software is itself a MEDICAL DEVICE or when software is an embedded or integral part of the final MEDICAL DEVICE.

This standard does not cover validation and final release of the MEDICAL DEVICE, even when the MEDICAL DEVICE consists entirely of software.

Relationship to other standards

This MEDICAL DEVICE SOFTWARE life cycle standard is to be used together with other appropriate standards when developing a MEDICAL DEVICE. HAnnex C shows the relationship between this standard and other relevant standards.

Compliance

Compliance with this standard is defined as implementing all of the PROCESSES, ACTIVITIES, and TASKS identified in this standard in accordance with the software safety class.

NOTE The software safety classes assigned to each requirement are identified in the normative text following the requirement.

Compliance is determined by inspection of all documentation required by this standard including the RISK MANAGEMENT FILE, and assessment of the PROCESSES, ACTIVITIES and TASKS required for the software safety class.

NOTE 1 This assessment could be carried out by internal or external audit.

NOTE 2 Although the specified PROCESSES, ACTIVITIES, and TASKS are performed, flexibility exists in the methods of implementing these PROCESSES and performing these ACTIVITIES and TASKS.

NOTE 3 Where any requirements contain "as appropriate" and were not performed, documentation for the justification is necessary for this assessment.

NOTE 4 The term "conformance" is used in ISO/IEC 12207 where the term "compliance" is used in this standard.