Customer Service:
Mon - Fri: 8:30 am - 6 pm EST


BS EN ISO 10993-1:October 2009

Biological evaluation of medical devices. Evaluation and testing within a risk management process (British Standard)

ISO 10993-1:2009 describes:

  • the general principles governing the biological evaluation of medical devices within a risk management process;
  • the general categorization of devices based on the nature and duration of their contact with the body;
  • the evaluation of existing relevant data from all sources;
  • the identification of gaps in the available data set on the basis of a risk analysis;
  • the identification of additional data sets necessary to analyse the biological safety of the medical device;
  • the assessment of the biological safety of the medical device.

Content Provider
British Standards Institution [bsi]

Others Also Bought

Biological evaluation of medical devices. Tests for in vitro cytotoxicity (British Standard)
Biological evaluation of medical devices. Tests for systemic toxicity (British Standard)
Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. General ...
Document History
Included in Packages
This standard is not included in any packages.
Amendments & Corrections
We have no amendments or corrections for this standard.

As the voice of the U.S. standards and conformity assessment system, the American National Standards Institute (ANSI) empowers its members and constituents to strengthen the U.S. marketplace position in the global economy while helping to assure the safety and health of consumers and the protection of the environment.