GB/T 44876-2024

Active

Implants for surgery—Cleanliness of orthopedic implants—General requirements

外科植入物 骨科植入物的清洁度 通用要求

Standard Type
GBT
ICS
11.040.40
CCS
C35
Status
Active
Issue Date
2024-10-26
Implementation
2025-11-01
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 general cleanliness requirements for orthopedic implants used in surgical procedures, including limits for residual biological debris, manufacturing particulates, and processing contaminants. It applies to manufacturers and quality control laboratories producing or testing devices such as hip, knee, and spinal implants to ensure patient safety and implant performance. The standard is used in the medical device industry, particularly during production validation and routine batch inspection.

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.