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ISO/TR 12417-2:2017

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

Standard Details

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 StandardDetails, 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.

General Information

Status : WITHDRAWN
Standard Type: Main
Document No: ISO/TR 12417-2:2017
Document Year: 2017
Pages: 29
Edition: 1
  • Section Volume:
  • ISO/TC 150/SC 2. Cardiovascular implants and extracorporeal systems
  • ICS:
  • 11.040.40 Implants for surgery, prosthetics and orthotics

Life Cycle

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WITHDRAWN
ISO/TR 12417-2:2017
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