Recognized Consensus Standards

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.

Transition Period

FDA recognition of AAMI TIR42:2010 [Rec# 3-99] will be superseded by recognition of AAMI TIR42:2021 [Rec# 3-172]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 3-99] until December 18, 2022. After this transition period, declarations of conformity to [Rec# 3-99] will not be accepted.

Public Law, CFR Citation(s) and Procode(s)*


Regulation Number	Device Name	Device Class	Product Code
Unclassified	Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring	Class 3	NWX
Unclassified	Coronary Drug-Eluting Stent	Class 3	NIQ
Unclassified	Drug-Coated Peripheral Transluminal Angioplasty Catheter	Class 3	PRC
Unclassified	Drug-Eluting Peripheral Transluminal Angioplasty Catheter	Class 3	ONU
Unclassified	Stent, Carotid	Class 3	NIM
Unclassified	Stent, Coronary	Class 3	MAF
Unclassified	Stent, Iliac	Class 3	NIO
Unclassified	Stent, Iliac Vein	Class 3	QAN
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
Regulation Number	Device Name	Device Class	Product Code
§870.5100	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Class 2	LOX
Regulation Number	Device Name	Device Class	Product Code
§870.1330	Wire, Guide, Catheter	Class 2	DQX
Regulation Number	Device Name	Device Class	Product Code
§870.1250	Catheter, Angioplasty, Peripheral, Transluminal	Class 2	LIT
§870.1250	Catheter, Percutaneous	Class 2	DQY
§870.1250	Catheter, Percutaneous, Cutting/Scoring	Class 2	PNO
Regulation Number	Device Name	Device Class	Product Code
§870.1210	Catheter, Continuous Flush	Class 2	KRA
Regulation Number	Device Name	Device Class	Product Code
§870.1200	Catheter, Intravascular, Diagnostic	Class 2	DQO