GB/T 19701.1-2024

Active

Implants for surgery—Ultra-high-molecular-weight polyethylene—Part 1: Powder form

外科植入物 超高分子量聚乙烯 第1部分:粉料

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 the requirements and test methods for ultra-high-molecular-weight polyethylene (UHMWPE) powder used in the manufacture of surgical implants, such as artificial joints. It is applied in the medical device industry to ensure the quality, purity, and consistency of the raw material before it is processed into implant components. The standard is critical for quality control in production and regulatory compliance testing of orthopedic implants.

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.