[SystemSafety] Medical devices (UK / EU)

[Andrew Banks]

Further to this, the associated Medical Devices Software "standard" (IEC 62304) is frankly not worth the paper it is printed on, with the most cursory of recommendations (not even requirements)

 

-----Original Message-----
From: systemsafety [mailto:systemsafety-bounces at lists.techfak.uni-bielefeld.de] On Behalf Of Peter Bernard Ladkin
Sent: 26 November 2018 09:41
To: systemsafety at lists.techfak.uni-bielefeld.de
Subject: Re: [SystemSafety] Medical devices (UK / EU)



On 2018-11-26 07:59 , Michael J. Pont wrote:
> This news report may be of interest to some on this list:
> https://www.bbc.co.uk/news/health-46337937

Yes, the International Consortium of Investigative Journalists, with which The Guardian, NYT, and Asahi Shimbun and I think the Süddeutsche Zeitung are partnered, has released a number of reports.
One in The Guardian today is
https://www.theguardian.com/society/2018/nov/25/revealed-faulty-medical-implants-harm-patients-around-world


Only some of the reports concern electrotechnical devices. Medical devices are regulated differently in terms of safety from others. Some electrotechnical standards are in the IEC 60601 series. But each country has its own approval procedures for such devices as well. When I look at the IEC WWW site there are a number of TCs with responsibility for various features of medical devices:
https://www.iec.ch/perspectives/government/sectors/medical_devices.htm

I have some information about pacemakers from one colleague who works for one of the few companies who make them. From what he has described, his company's procedures are pretty much a paradigm for dependable digital kit. FM on the code and HW; detailed analysis of each and every "event" which occurs with one of their users, as well as following events which occur to users of other companies'
equipment.

PBL

Prof. Peter Bernard Ladkin, Bielefeld, Germany MoreInCommon Je suis Charlie
Tel+msg +49 (0)521 880 7319  www.rvs-bi.de