This document specifies the basic requirements for type testing, animal experimental research and clinical evaluation of active implantable circulatory support devices. This document applies to active implantable circulatory support devices such as ventricular assist devices, including left heart assist devices, right heart assist devices, total artificial hearts, biventricular assist devices, percutaneous assist devices, pediatric assist devices, etc. This document also applies to some non-implantable components and accessories of active implantable circulatory support devices. This document does not apply to routine inspection during production.
YY/T 0989.5-2022 history
2022YY/T 0989.5-2022 Surgical implants Active implantable medical devices Part 5: Circulatory support devices