YY standards

NMPA Mandatory and Recommended YY Standards

NMPA published its mandatory YY standards and recommended YY standards modification plan on May 23, 2023 (Refer to Notification 17-2023). Below are some of the standards:

Cardiopulmonary diversion system:Disposable arteriovenous cannula (YY 0948-2015, ISO 18193:2021)

Single-use hollow fiber blood filter ( YY 0465-2019,  ISO 8637-3:2018 )

Medical Electrical Equipment Part 2-87: Specific requirements for basic safety and basic performance of high-frequency ventilators (Initiation, ISO 80601-2-87:2021)

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