GB/T 19701.5-2024

Active

Implants for surgery—Ultra-high-molecular-weight polyethylene—Part 5:Morphology assessment method

外科植入物 超高分子量聚乙烯 第5部分:形态评价方法

Standard Type
GBT
ICS
11.040.40
CCS
C35
Status
Active
Issue Date
2024-11-28
Implementation
2025-12-01
Centralized Committee
国家药监局
Issuing Authority
国家市场监督管理总局、国家标准化管理委员会

Application Summary AI generated

This standard specifies a method for assessing the morphology of ultra-high-molecular-weight polyethylene (UHMWPE) used in surgical implants, such as artificial hip and knee joints. It is applied in the medical device industry to evaluate the material's crystalline structure and surface characteristics, ensuring consistent quality and performance for load-bearing orthopedic applications. The testing context involves manufacturers and quality control laboratories verifying implant materials against regulatory requirements.

Related Standards

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.