ISO/TR 12417-2:2022 ✓ Most Recent

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Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 2: Local regulatory information

standard by International Organization for Standardization (Technical Report) , 07/01/2022

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Full Description

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.

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  1. ISO/TR 12417-2:2022

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    Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 2: Local regulatory information

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  2. ISO/TR 12417-2:2017


    Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 2: Local regulatory information

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Product Details

Published:

07/01/2022

Number of Pages:

36

File Size:

1 file

Same As:

BS PD ISO/TR 12417-2:2022

Note:

This product is restricted and cannot be purchased in the following countries Ukraine, Russia, Belarus