Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

057

Date of Entry 12/20/2021

FR Recognition Number

3-172

Standard

AAMI TIR42:2021
Evaluation of Particulates Associated with Vascular Medical Devices

Scope/Abstract

This document provides information for defining appropriate test methods, determining the source of particulate, assessing the clinical risk of particulate, and establishing product particulate limits. Particulate could arise from many sources including materials, environment, and clinical use. This TIR is intended to offer guidance to the medical device industry when evaluating the tendency for medical devices to release particulate, identifying particulate sources, applying analytical methods for particulate testing, and developing particulate limits based on clinical risk.

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
§870.1200	Catheter, Intravascular, Diagnostic	Class 2	DQO
§870.1210	Catheter, Continuous Flush	Class 2	KRA
§870.1250	Catheter, Percutaneous	Class 2	DQY
§870.1250	Catheter, Angioplasty, Peripheral, Transluminal	Class 2	LIT
§870.1250	Catheter, Percutaneous, Cutting/Scoring	Class 2	PNO
§870.1330	Wire, Guide, Catheter	Class 2	DQX
§870.5100	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Class 2	LOX
N/A	Stent, Coronary	Class 3	MAF
N/A	System, Endovascular Graft, Aortic Aneurysm Treatment	Class 3	MIH
N/A	Transcatheter Septal Occluder	Class 3	MLV
N/A	Stent, Carotid	Class 3	NIM
N/A	Stent, Renal	Class 3	NIN
N/A	Stent, Iliac	Class 3	NIO
N/A	Stent, Superficial Femoral Artery	Class 3	NIP
N/A	Coronary Drug-Eluting Stent	Class 3	NIQ
N/A	Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring	Class 3	NWX
N/A	Drug-Eluting Peripheral Transluminal Angioplasty Catheter	Class 3	ONU
N/A	Drug-Coated Peripheral Transluminal Angioplasty Catheter	Class 3	PRC
N/A	Stent, Iliac Vein	Class 3	QAN

Relevant FDA Guidance and/or Supportive Publications*

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.

FDA Technical Contacts

Dinesh Patwardhan

FDA/OC/CDRH/OSEL/

301-796-2622

dinesh.patwardhan@fda.hhs.gov

Eleni Whatley

FDA/OC/CDRH/OPEQ/OHTII/DHTIIC/

301-796-6372

Eleni.Whatley@fda.hhs.gov

Standards Development Organization

AAMI

Association for the Advancement of Medical Instrumentation