ISO/TR 12417-2:2017

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

Publication date:   Nov 21, 2017

95.99 Withdrawal of Standard   Jul 7, 2022

General information

95.99 Withdrawal of Standard   Jul 7, 2022

ISO

ISO/TC 150/SC 2 Cardiovascular implants and extracorporeal systems

Technical Report

11.040.40   Implants for surgery, prosthetics and orthotics

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Scope

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.

Life cycle

NOW

WITHDRAWN
ISO/TR 12417-2:2017
95.99 Withdrawal of Standard
Jul 7, 2022

REVISED BY

PUBLISHED
ISO/TR 12417-2:2022