SS-EN ISO 12417-1:2024
Current
The latest, up-to-date edition.
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.
Committee |
ISO/TC 150
|
DocumentType |
Standard
|
Pages |
60
|
PublisherName |
Standardiserings-Kommissionen I Sverige
|
Status |
Current
|
Supersedes |
Standards | Relationship |
EN ISO 12417-1:2024 | Identical |
ISO 12417-1:2024 | Identical |
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