GB/T 16886.4-2022
ActiveBiological evaluation of medical devices—Part 4: Selection of tests for interactions with blood
医疗器械生物学评价 第4部分：与血液相互作用试验选择
Application Summary AI generated
This standard specifies the selection criteria for evaluating the interactions between medical devices and blood, including tests for hemolysis, thrombosis, and complement activation. It is applied in the biological safety assessment of blood-contacting medical devices, such as catheters, stents, and hemodialyzers, during preclinical testing and regulatory approval processes. The standard guides manufacturers and testing laboratories in China to choose appropriate in vitro and in vivo assays based on device type and contact duration.
Related Standards
GB/T 19381-2003
General methods of test for medical closures of butyl rubber
GB/T 14214-2003
Spectacle frames--General requirements and test methods
GB/T 18375.5-2004
Prosthetics--Structural testing of lower-limb prostheses--Part 5:Supplementary structural tests
GB/T 18375.7-2004
Prosthetics--Structural testing of lower-limb prostheses--Part 7:Test submission document
GB/T 18375.6-2004
Prosthetics--Structural testing of lower-limb prostheses--Part 6:Loading parameters of supplementary structural tests
GB/T 18375.8-2004
Prosthetics--Structural testing of lower-limb prostheses--Part 8:Test report
GB/T 19543-2004
Prostheses--Structural testing of hip units
GB/T 19629-2005
Medical Electrical Equipment-Dosimeters with ionization chambers and/or semi-conductors as used in X-ray diagnostic imaging
Transparency note: The application summary and key sentences on this page were automatically generated by AI from the standard's original text. This content has not been human-verified and should not be used for compliance or regulatory purposes. Always refer to the official standard document from the issuing authority.