• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 050 Date of Recognition 10/22/2018 
FR Recognition Number 3-99
Standard
AAMI TIR 42:2010
Evaluation of Particulates Associated with Vascular Medical Devices
Scope/Abstract
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.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)
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
Relevant FDA Guidance and/or Supportive Publications
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.
FDA Technical Contacts
 Dinesh Patwardhan
  FDA/OMPT/CDRH/OSEL/
  301-796-2622
  dinesh.patwardhan@fda.hhs.gov
 Eleni Whatley
  FDA/OMPT/CDRH/ODE/DCD/PIDB/
  301-796-6372
  Eleni.Whatley@fda.hhs.gov
Standards Development Organization
AAMI Association for the Advancement of Medical Instrumentation http://www.aami.org
FDA Specialty Task Group (STG)
Cardiovascular
-
-