I see the web page Equipment standards, guidance and legislation" seems to be full of outdated information.

There is no need to mention outdated documents (HTM 8, BS5724, HEI 95, DB9801, MHRA DB2006(05)), unless as part of a section called "Historical Guidance". The "Future Guidance" section is outdated as it is now the current guidance (BS EN 62353 is already at the second edition). This is also mentioned in the MHRA Managing Medical Devices (2015) document , which will be updated in 2020.

I suggest the whole page is re-written or removed to avoid confusion. BS EN 62353:2014 is the only standard that should be used for testing of ME equipment after manufacturer.

Also your contact page fails to work and just throws up errors!

Thanks for the feedback Mike. We will look into this.

The contact form has been working all week, so this must be an issue that happened in the last upgrade.
Looking into it now.

EDIT - Fixed.

Link?


I agree that readers should always be pointed in the direction of the current official "guidance", where ever and what ever that may be ... but I also believe that a historical narrative is useful ("how we arrived at where we now are ..." etc.).

Perhaps you might like to draft both such documents for us all to admire, Mike ... and then make sure that the "current guidance" is always kept up to date.

The link is ebme.co.uk/articles/electrical-safety/equipment-standards-guidance-and-legislation

If I get some time I may put something together. In the mean time maybe mark pages like this as "outdated and under review" so readers are not mislead?

Thank you, Mike.

Meanwhile, perhaps one of the Gurus at Eastwood Park might like to review it (and update where necessary).

Presumably their students are given the latest information?

In case any lingering doubts remain, the MHRA document "Managing Medical Devices" (Apr 2015) provides the current official guidance in the UK.

See also Legislation ... ... which also contains some links that no longer work.

That's the trouble with placing links in documents; keeping them up to date becomes a full time job!

This is mainly historical. I will write a new article on current equipment standards, guidance and legislation, hopefully done by the end of this month.