ISO 12417:2022
ISO 12417:2022 Cardiovascular implants and extracorporeal systems – Vascular device-drug combination products – Part 2: Local regulatory information
CDN $295.00
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.
Edition
2
Published Date
2022-07-07
Status
PUBLISHED
Pages
29
Language
English
Format
Secure PDF
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Abstract
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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