What is this standard about?
It is a specification stating general requirements for evaluating the interactions of medical devices with blood.
Who is this standard for?
Test laboratories and medical devices manufacturers.
Why should you use this standard?
Because it describes:
- A classification of medical devices intended for use in contact with blood, based on the intended use and duration of contact defined in BS EN ISO 10993-1
- The fundamental principles governing the evaluation of the interaction of devices with blood
- The rationale for structured test selection according to specific categories, together with the principles and scientific basis of these tests
What’s changed since the last update?
The 2009 version was updated to match the current tools and techniques used to evaluate medical device blood material interactions. This includes a more current description of in vitro techniques that rely less on the use of animals and generate more predictive results.