1.1   This practice describes biological test methods (as listed in 2.1) which may be used in support of a biological evaluation of materials and medical devices according to end-use applications. Biological evaluation is a component of a broader safety evaluation and is conducted within an ISO 14971 risk management framework. ISO 10993‑1 sets out the general principles and requirements for such an evaluation. A biological evaluation conducted according to ISO 10993‑1 requires a consideration of the composition of the medical device and the review of pre-existing information pertinent to biological risks. In many cases this pre-existing information will be sufficient to establish safety without a need for additional testing. Only where existing information is insufficient it may be necessary to conduct further testing (see ISO 10993‑1). The purpose of this document is to provide guidance on available and applicable test methods to support such testing activities if they are required.