Follow our blog and keep informed of key standards, regulatory and technological developments in the medical devices sector.
Enhancing the usability of medical electrical equipment safety standard
It’s critical that medical electrical equipment performs as intended and safely. To these ends, we’ve amended one of the core European standards in this area. This blog post explains what the standard covers and what’s been changed by the amendments.
What’s happened to the British laboratory autoclave standard?
It’s fair to say that the British Standard specifying laboratory autoclaves was overdue for a revision, having been reviewed regularly but not changed since 1993. This blog post discusses the big changes that have now taken place.
Explaining Test to Release and the role of two international standards
In relation to international travel into the UK, how does Test to Release and the new Day 2 & Day 8 international arrival testing work, and what part do two international standards play in the Government’s scheme? This blog post sets out the details.
The biological evaluation of medical devices takes a new direction
The international safety standard on the biological evaluation of medical devices within a risk management process has undergone a lengthy and comprehensive revision. This blog post discusses the results.
Why we’ve updated the British Standard on methylene blue particulate penetration testing
A newly revised British Standard describes how to perform microbial barrier testing using the methylene blue particulate penetration method. This blog post explains why the standard has been updated and why it should be used by medical device manufacturers.