Standard for medical device software

Consolidated IEC 62304 issued, available as Redline version

By Morand Fachot

Software is often an integral part of medical device technology and trends point to its growing importance in it. A consolidated version of IEC 62304, Medical device software– Software life cycle processes, has just been published. This International Standard provides a framework of life cycle processes with activities and tasks necessary for the safe design and maintenance of medical device software.

The LIFEPAK® 15 monitor/defibrillator can also send patient data (Photo: © 2013 Physio-Control, Inc)
The LIFEPAK® 15 monitor/defibrillator can also send patient data which must protected (Photo: © 2013 Physio-Control, Inc)

Software becomes more and more important in medical devices

In its Strategic Business Plan, IEC Technical Committee (TC) 62: Electrical equipment in medical practice, notes that "software and the integration of medical electrical equipment and systems with IT networks will be an integral element affecting almost all aspects of the [TC] work." It further states that in recent years it "has increasingly worked in the field of software, IT and networks and developed new International Standards and other publications in that area."

IEC Subcommittee (SC) 62A: Common aspects of electrical equipment used in medical practice, develops a number of International Standards that are specifically related to software issues.

Consolidated version includes significant additions

The consolidated version of IEC 62304, includes the initial Standard, published in 2006, and Amendment 1 (2015), which adds requirements to deal with legacy software, to assist manufacturers who must show compliance to the Standard to meet European Directives. Clarification of requirements and updating of the software safety classification to include a risk-based approach have also been added to the amendment.

Covering all aspects

The scope of this standard is quite wide, it "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."

It is also "to be used together with other appropriate standards when developing a medical device."

In addition to terms and definitions, the Standard lists general requirements, which include conditions applying to legacy software, and details:

  • Software development process (development planning, requirements analysis, architectural and detailed design, implementation and verification, integration and integration testing, software system testing and release)  
  • Software maintenance process
  • Software risk management process, with risk being defined as the combination of the probability of occurrence of harm [physical injury, damage, or both to the  health of people or damage to property or the environment] and the severity of that harm
  • Software configuration management process
  • Software problem resolution process

Standard available as Redline version

Given the extent of changes in this consolidated Standard, it is available as a Redline version with track changes.

Redline versions (available in English only) provide users with a quick and easy way of comparing all the changes between standards and their previous edition, as such they are highly valued. In Redline version, a vertical bar appears in the margin wherever a change has been made. Additions and deletions are displayed in red, with deletions being struck through. First introduced in 2008, Redline versions are now available for over 50 International Standards.

medical exam data Patients' data is now often kept and transferred in electronic format (Photo: Zeiss)
remote doctor consultation Remote presence solution for patient care like this RP-VITA rely on software (Photo: iRobot Corp)
defibrillator The LIFEPAK® 15 monitor/defibrillator canalso send patient data which must protected (Photo: © 2013 Physio-Control, Inc)