PD ISO/TR 12417-2:2022 PDF

Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products - Local regulatory information

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PD ISO/TR 12417-2:2022

Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products - Local regulatory information

Статус документа:: Действующий
Формат:: Электронный (PDF)
Дата публикации:: 31 июля 2022 г.
ICS:: 11.040.40
SKU:: PD ISO/TR 12417-2:2022

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Abstract

1 Scope 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.

PD ISO/TR 12417-2:2022 PDF

Abstract

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Abstract

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