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SS-EN ISO 12417-1:2024
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The latest, up-to-date edition.
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Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 1: General requirements (ISO 12417-1:2024, IDT)
Hardcopy
English
20-05-2024
This document specifies requirements for vascular device-drug combination products (VDDCPs). With regard to safety, this document outlines requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer.
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