Reference for Common Series Standards for Final Sterilization Medical Device Packaging

Packaging for terminally sterilized medical devices is fundamental to ensuring medical device safety. On March 17, 2021, China announced the new "Regulations on the Supervision and Administration of Medical Devices," which took effect on June 1, 2021. The new regulations strictly implement the "Four Strictest" requirements, adapting to the rapid development trends of China's medical device industry in recent years. Consequently, the regulations and standards for packaging systems are becoming increasingly standardized and comprehensive. This article briefly lists several commonly used series of standards in China for reference.

Parts 1 and 2 of this standard are identical to ISO 11607. They specify the requirements for materials, sterile barrier systems, and packaging systems for terminally sterilized medical devices, as well as the requirements for the development and validation of packaging processes.

Parts 1 to 10 of this series specify the detailed requirements and test methods for materials used in packaging for terminally sterilized medical devices.

Parts 1 to 18 of this series specify specific test methods for packaging of terminally sterilized medical devices.

Parts 1 and 2 of this series are identical to ISO 15223. They specify requirements for labels, markings, and information-supplying symbols.