GB/T 19633.1-2024

Active

Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems and packaging systems

最终灭菌医疗器械包装 第1部分:材料、无菌屏障系统和包装系统的要求

Standard Type
GBT
ICS
11.080.01
CCS
C47
Status
Active
Issue Date
2024-05-28
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 requirements for materials, sterile barrier systems, and packaging systems used for medical devices that undergo terminal sterilization. It is applied in the healthcare industry by medical device manufacturers and packaging suppliers to ensure packaging integrity and sterility maintenance from production through to point of use. The standard is relevant for products such as surgical instruments, implants, and diagnostic equipment that require validated sterile packaging.

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.