GB/T 16886.14-2003
ActiveBiological evaluation of medical devices--Part 14:Identification and quantification of degradation products from ceramics
医疗器械生物学评价 第14部分:陶瓷降解产物的定性与定量
Application Summary AI generated
This standard specifies methods for identifying and quantifying degradation products released from ceramic materials used in medical devices. It is applied during the biological evaluation of ceramic implants, such as dental or orthopedic prosthetics, to assess potential risks from material breakdown in physiological environments. The testing context involves analyzing degradation byproducts to ensure compliance with safety requirements for long-term implantation.
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 18375.6-2004
Prosthetics--Structural testing of lower-limb prostheses--Part 6:Loading parameters of supplementary structural tests
GB/T 18375.7-2004
Prosthetics--Structural testing of lower-limb prostheses--Part 7:Test submission document
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.