YY/T 0989.5-2022Surgical implants - Active implantable medical devices - Part 5: Circulatory support devices (English PDF)

YY/T 0989.5-2022 (Surgical implants - Active implantable medical devices - Part 5: Circulatory support devices) is available as an English-translated PDF.

YY/T 0989.5-2022 — This standard specifies the basic requirements for type testing, animal experimental research and clinical evaluation of active implantable circulatory support devices.

This standard applies to active implantable circulatory support devices such as left ventricular assist devices, right ventricular assist devices, total artificial hearts, biventricular assist devices, percutaneous assist devices, and pediatric assist devices.

This standard also applies to some non-implanted components and accessories of active implantable circulatory support devices.

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 30 pages — is available in the English PDF.

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