Technical Standard

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This document provides region-specific information for:

— local submissions and approvals for vascular device-drug combination products (VDDCPs) in countries and regions around the world;
— changes related to the drug-containing part and how they are evaluated by different local regions.

For implanted products, this document is considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants.

This document is considered also as a supplement to ISO 12417-1, and any relevant device-specific standards, such as the ISO 25539 series specifying requirements for endovascular devices. This document also addresses VDDCPs that are not necessarily permanent implants.

Product Details

Published:

07/31/2022

ISBN(s):

9780539184716

Number of Pages:

38

File Size:

1 file , 1.6 MB

Same As:

ISO/TR 12417-2:2022

Product Code(s):

30440681, 30440681, 30440681

Note:

This product is unavailable in Ukraine, Russia, Belarus