Recognized Consensus Standards

Recognition List Number: 029 Publication Date: 08/20/2012

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 3-56: ASTM F1841-97 (2005), Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps. (Cardiovascular)

Date of Standard: 2005.

Address of Standards Organization:

ASTM International (ASTM)

100 Barr Harbor Drive

West Conshohocken, PA 19428-2959

CDRH Office and Division Associated with Recognized Standards:

	OFFICE OF DEVICE EVALUATION (ODE)
	DIVISION OF CARDIOVASCULAR DEVICES (DCD)

Devices Affected:

Continuous Flow Blood Pumps for Short Term (<=6 HRS) Durations of Use

Processes Affected:

510(k), PMA, IDE, PDP, HDE, Design Control Input, Quality System Regulation

Type of Standard:

International, Vertical

Extent of Recognition:

Complete Standard except as noted below

NOTE: In general, this standard provides some basic guidelines for performing hemolysis testing on blood pumps expected to be use for up to 6 hours. Short-term bench-top hemolysis testing is not sufficient for making regulatory decisions for devices intended for long-term use (greater than 6 hours duration), and should only be considered useful for supplementary testing at conditions beyond those which might be performed in animals. Due to variations in the design and clinical use of different blood pumps, the test methodology and parameters (e.g. flow rate, pressure, temperature) described in the ASTM F1841 standard may need to be adjusted.

Related CFR Citations and Product Codes:

Regulation Number	Device Name	Device Class	Product Code
§870.4360	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type	Class 3	KFM

Regulation Number	Device Name	Device Class	Product Code
§870.4370	Pump, Blood, Cardiopulmonary Bypass, Roller Type	Class 2	DWB