GB/T 25440.1-2010

Abolished

Retrieval and analysis of surgical implants - Part 1: Retrieval and handling

外科植入物的取出与分析 第1部分:取出与处理

Standard Type
GBT
ICS
11.040.40
CCS
C45
Status
Abolished
Issue Date
2010-11-10
Implementation
2011-05-01
Centralized Committee
国家药监局
Issuing Authority
中华人民共和国国家质量监督检验检疫总局、中国国家标准化管理委员会

Application Summary AI generated

This standard specifies procedures for the retrieval, handling, and documentation of surgical implants removed from patients, ensuring traceability and preservation of evidence for failure analysis. It is applied in clinical settings, such as hospitals and orthopedic surgery departments, to guide surgeons and pathologists in collecting explanted devices (e.g., hip or knee prostheses) for subsequent laboratory examination. The standard supports quality control and safety assessments in the medical device industry by enabling systematic investigation of implant performance and biocompatibility issues.

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.