What is this standard about?
It identifies the significant standards and guides that can be used to assess if an In Vitro Diagnostic (IVD) medical device is safe and performs as intended.
Six general principles for safety and performance that apply to all IVD medical devices are outlined. It also describes fundamental design and manufacturing criteria.
Who is this standard for?
IVD medical device manufacturers
Why should you use this standard?
Because it includes the specific essential principles for all IVD medical devices which were not included in the scope of part one.
What’s changed since the last update?
When the technical report on which this standard was based – ISO/TR 16142 – was revised, the technical committee decided to split the standard between non-IVD and IVD medical devices.
This standard also updates the technical report to take in the new essential principles set out by the international medical device regulators forum.
