logo

Standards Manage Your Business

We Manage Your Standards

ISO

ISO/TR 12417-2:2022

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

Standard Details

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 StandardDetails, such as the ISO 25539 series specifying requirements for endovascular devices. This document also addresses VDDCPs that are not necessarily permanent implants.

General Information

Status : Published
Standard Type: Main
Document No: ISO/TR 12417-2:2022
Document Year: 2022
Pages: 29
Edition: 2
  • Section Volume:
  • ISO/TC 150/SC 2. Cardiovascular implants and extracorporeal systems
  • ICS:
  • 11.040.40 Implants for surgery, prosthetics and orthotics

Life Cycle

Currently Viewing

Published
ISO/TR 12417-2:2022
Knowledge Corner

Expand Your Knowledge and Unlock Your Learning Potential - Your One-Stop Source for Information!

© Copyright 2024 BSB Edge Private Limited.

Enquire now +