GB/T 16886.15-2003
AbolishedBiological evaluation of medical devices--Part 15:Identification and quantification of degradation products from metals and alloys
医疗器械生物学评价 第15部分:金属与合金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 metallic and alloy components of medical devices. It is applied during biocompatibility testing to evaluate the potential toxicological risks of implants, surgical instruments, and other devices that contact body tissues or fluids. The standard ensures consistent analysis of metal ion release, supporting safety assessments for regulatory approval and quality control in medical device manufacturing.
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 18375.6-2004
Prosthetics--Structural testing of lower-limb prostheses--Part 6:Loading parameters of supplementary structural tests
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 18375.8-2004
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.