Software in Medical Devices, by MD101 Consulting

IEC 62304 1st edition, amendment 1 and IEC 62304 2nd edition

The ISO TC 210/JWG 2 (Joint Working Group #2: Medical device software) is in charge of writing the next version of IEC 62304. It shares this responsibility with the IEC/SC 62A WG (International Electrotechnical Commission, sub-committee #62A Working Group.

Two draft versions of IEC 62304 are in the pipes of this working group:

• An update of IEC 62034, called IEC 62304 1st edition, amendment 1 (or IEC 62304 am1 Ed. 1.0)
• A new version of IEC 62304, called IEC 62304 2nd edition (or IEC 62304 Ed. 2.0)

IEC 62304 am1 Ed. 1.0 mainly adds requirements to deal with legacy software with a new normative annex E, titled Application of software lifecycle PROCESSES for LEGACY SOFTWARE.
IEC 62304 am1 Ed. 1.0 forecasted publication date is: december 2015.

IEC 62304 Ed. 2.0 is still in early draft status, and shouldn't be published before 2016.

IEC 62366 Am1, IEC 62366-1 and IEC 62366-2

The amendment 1 of IEC 62366 was published in January 2014.
The amendment updates the normative part of the current version of IEC 62366, by new requirements about UOUP: User interface of Unkown Provenance. The UOUP concept is the transcription for user interfaces of the SOUP concept found in IEC 62304. Similarly to IEC 62034, the concept of UOUP is applicable to legacy devices.

Those who have already read IEC 62366 know how long this standard is, bloated with dozens of (not systematically useful) examples.
There was a decision of IEC/SC 62A WG to split in two parts:

• IEC 62366-1: Medical devices - Part 1: Application of usability engineering to medical devices
• IEC 62366-2: Medical devices - Part 2: Guidance on the application of usability engineering to medical devices

IEC 62366-1 contains the normative parts of the standard, including those found in amendment 1. IEC 62366-1 will also contain the latest revision of ANSI/AAMI HE74 HFE process.

IEC 62366-1 is close to official publication, forecasted publication date is: january 2015.

IEC 62366-2 is still in draft status, and shouldn't be published before 2016.

And ISO 14971?

There is no ongoing revision of ISO 14971:2007. This version was confirmed in 2010 and no change is forecasted since then.
For those who are curious or like enriching their general knowledge, a technical report was published in 2013: ISO/TR 24971:2013 Medical devices -- Guidance on the application of ISO 14971.

Conclusion

Regarding standards about software in medical devices, the pace of changes is slow. Hence there is a limited number of standards applicable to standalone software, standards changes are not very common. But, with the coordination of working groups agendas, 2015 will be the year where IEC 62034 and IEC 62366 will be updated.