AAMI TIR 42:2010

Evaluation Of Particulates Associated With Vascular Medical Devices

TIR 42:2010

Standard Organization: AAMI

AAMI TIR 42:2010
Evaluation of Particulates Associated with Vascular Medical Devices

Recognition NumberCardiovascular
Recognition Date2018-10-22
Recognition List050
Recognition Number3-99
Extent Complete standard
Standards Orgs AAMI Association for the Advancement of Medical Instrumentation http://www.aami.org
STG Cardiovascular
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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:

This technical information report (TIR) addresses vascular exposure to particles arising from the manufacturing environment for vascular medical devices and from the use of vascular medical devices. It is intended to assist vascular medical device manufacturers in determining the source of particulates, establishing product particulate limits, defining appropriate test methods, and assessing the clinical relevance of particulate contamination.

Code of Federal Regulations:

Regulation Number Device Name Device Class Product Code
§870.5100 Catheters, Transluminal Coronary Angioplasty, Percutaneous Class 2 LOX
Unclassified Coronary Drug-Eluting Stent Class 3 NIQ
Unclassified Stent, Carotid Class 3 NIM
Unclassified Stent, Coronary Class 3 MAF
Unclassified Stent, Iliac Class 3 NIO
Unclassified Stent, Renal Class 3 NIN
Unclassified Stent, Superficial Femoral Artery Class 3 NIP
Unclassified System, Endovascular Graft, Aortic Aneurysm Treatment Class 3 MIH
Unclassified Transcatheter Septal Occluder Class 3 MLV

FDA Guidance:

Guidance for Industry Coronary Drug-Eluting Stents¿ Nonclinical and Clinical Studies, Issued March 2008.

Guidance for Industry and FDA Staff: Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems, Issued April 2010.

Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document for Certain percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, Issued May 2008.

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