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YY/T 0989.5-2022 English PDF

US$989.00 ยท In stock
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YY/T 0989.5-2022: (Surgical implants - Active implantable medical devices - Part 5: Circulatory support devices)
Status: Valid
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY/T 0989.5-2022English989 Add to Cart 6 days [Need to translate] (Surgical implants - Active implantable medical devices - Part 5: Circulatory support devices) Valid YY/T 0989.5-2022

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YY 0989.7   YY/T 0988.14   YY/T 0987.5   YY 0989.3   YY/T 0988.3   YY/T 0987.1   

Basic data

Standard ID YY/T 0989.5-2022 (YY/T0989.5-2022)
Description (Translated English) (Surgical implants - Active implantable medical devices - Part 5: Circulatory support devices)
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C35
Word Count Estimation 45,495
Date of Issue 2022-10-17
Date of Implementation 2023-10-01
Issuing agency(ies) State Drug Administration
Summary 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. This standard does not apply to routine inspections during production.

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