GB/T 44353.2-2024

Active

Medical devices utilizing animal tissues and their derivatives—Part 2:Controls on sourcing, collection and handling

动物源医疗器械 第2部分:来源、收集与处置的控制

Standard Type
GBT
ICS
11.100.20
CCS
C30
Status
Active
Issue Date
2024-08-23
Implementation
2025-09-01
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 requirements for controlling the sourcing, collection, and handling of animal tissues and their derivatives used in medical devices. It is applied by manufacturers and regulatory bodies in the healthcare industry to ensure traceability, risk management, and safety compliance for products such as biological heart valves, surgical sutures, and wound dressings derived from animal sources.

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.