What is BS EN ISO 10993-1:2020 about?
A biological evaluation needs to be done before any medical device can interact with the human body. BS EN ISO 10993-1:2020 helps users plan and conduct such biological evaluations reliably and cost-effectively.
Who is BS EN ISO 10993-1:2020 for?
- Medical device manufacturers
- Test laboratories
- Regulators
- Notified Bodies
Why should you use BS EN ISO 10993-1:2020?
It provides a framework for planning and conducting biological evaluations of medical devices.
The revision underlines that the standard is not about test selection but about the collection and evaluation of all types of data that are relevant to biological safety. This should lead to more reliable and cost effective evaluations.
What’s new about BS EN ISO 10993-1:2020?
The standard was revised to minimize the use of test animals by preferring in vitro models and material characterization.
Annex A has been changed to include physical and/or chemical information as part of the endpoints to be addressed in a biological risk assessment. This has now become a prerequisite for any risk assessment.
Guidance on the conduct of biological evaluation within a risk management process has been expanded to include material characterization concepts.