ANSI AAMI ISO 25539-1: 2017

Cardiovascular Implants - Endovascular Devices - Part 1: Endovascular Prostheses

25539-1: 2017

Standard Organization: ANSI AAMI ISO

ANSI AAMI ISO 25539-1: 2017
Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses

Recognition NumberCardiovascular
Recognition Date2019-01-14
Recognition List051
Recognition Number3-157
Extent Complete standard
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STG Cardiovascular
FDA Tech  Dorothy Abel   FDA/OMPT/CDRH/ODE/DCD/VSDB/   301-796-6366   dorothy.abel@fda.hhs.gov

Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Scope:

25539-1 specifies requirements for the evaluation of endovascular systems (prostheses and delivery systems) and requirements with respect to nomenclature, design attributes and information supplied by the manufacturer based upon current medical knowledge. Guidance for the development of in vitro test methods is included in an informative annex to this document. This document can be considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants.

Code of Federal Regulations:

Regulation Number Device Name Device Class Product Code
Unclassified Coronary Covered Stent Class f NIV
Unclassified System, Endovascular Graft, Aortic Aneurysm Treatment Class 3 MIH

FDA Guidance:

There is no relevant guidance developed at this time.


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