GB/T 25440.2-2021

Active

Retrieval and analysis of surgical implants—Part 2: Analysis of retrieved surgical implants

外科植入物的取出与分析 第2部分:取出外科植入物的分析

Standard Type
GBT
ICS
11.040.40
CCS
C45
Status
Active
Issue Date
2021-11-26
Implementation
2022-12-01
Centralized Committee
国家药监局
Issuing Authority
国家市场监督管理总局、中国国家标准化管理委员会

Application Summary AI generated

This standard specifies the methods and procedures for analyzing surgical implants after they have been removed from the body, including macroscopic examination, microscopic analysis, and material characterization. It is applied in clinical and research settings to evaluate implant performance, identify failure mechanisms such as wear, corrosion, or fracture, and improve future implant design and patient safety. The standard is relevant for orthopedic, dental, and cardiovascular implant retrieval programs and post-market surveillance activities.

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.