GB/T 19701.2-2024
ActiveImplants for surgery—Ultra-high-molecular-weight polyethylene—Part 2: Moulded forms
外科植入物 超高分子量聚乙烯 第2部分：模塑料
Application Summary AI generated
This standard specifies the requirements for moulded forms of ultra-high-molecular-weight polyethylene (UHMWPE) used in surgical implants, including material properties, processing conditions, and testing methods. It is applied in the medical device industry for the manufacturing and quality control of components such as acetabular cups, knee bearing surfaces, and other load-bearing orthopedic implants. The standard ensures consistency and biocompatibility for implants intended for long-term human 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 18375.7-2004
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 18375.5-2004
Prosthetics--Structural testing of lower-limb prostheses--Part 5:Supplementary structural tests
GB/T 19543-2004
Prostheses--Structural testing of hip units
GB/T 18375.8-2004
Prosthetics--Structural testing of lower-limb prostheses--Part 8:Test report
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.