ISO/TR 12417-2:2017

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

Published By	Publication Date	Number of Pages
ISO	2017-11	36

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Categories: 11.040.40 - Implants for surgery, prosthetics and orthotics, ISO

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Description

ISO/TR 12417-2:2017 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 the 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.

ISO/TR 12417-2:2017 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. Requirements listed in this document also address VDDCPs that are not necessarily permanent implants.

Additional information

Published Code	ISO
Published By	International Organization for Standardization
Publication Date	2017-11
Pages Count	36
Language	English
Edition	1
File Size	532.5 KB
ICS Codes	11.040.40 - Implants for surgery, prosthetics and orthotics

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ISO/TR 12417-2:2017

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