This Standard is applicable to the biological evaluation of medical devices in accordance with the requirements in GB/T 16886.1-2011. This Standard does not add or modify the requirements in GB/T 16886.1-2011. This Standard does not include requirements of regulatory inspection or certification and assessment activities. This Standard is applicable to all the biological evaluation of various types of medical devices, including active, passive, implantable and non-implantable medical devices.

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.