Recognized Consensus Standards

Recognition List Number: 006 Publication Date: 10/01/2001

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 3-38: IEC 60601-2-34 (2000-10), Medical electrical equipment - Part 2-34: Particular requirements for the safety, including essential performance, of invasive blood pressure monitoring equipment. (Cardiovascular)

Date of Standard: 2000.

Address of Standards Organization:

International Electrotechnical Commission (IEC)

3, Rue de Varembe'

PO Box 131

CH-1211 Geneva 20, 0

SWITZERLAND

CDRH Office and Division Associated with Recognized Standards:

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

Devices Affected:

Invasive blood pressure monitors, including transducers

Processes Affected:

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

Type of Standard:

International, Vertical

Extent of Recognition:

IEC 60601-2-34 is recognized completely except for the following change:

a. The IEC 60601-2-34 standard deals only with safety issues. FDA is free to require testing to verify effectiveness issues.

Related CFR Citations and Product Codes:

Regulation Number	Device Name	Device Class	Product Code
§870.1110	Computer, Blood-Pressure	Class 2	DSK

Regulation Number	Device Name	Device Class	Product Code
§870.2060	Amplifier And Signal Conditioner, Transducer Signal	Class 2	DRQ

Regulation Number	Device Name	Device Class	Product Code
§870.2850	Transducer, Blood-Pressure, Extravascular	Class 2	DRS

Regulation Number	Device Name	Device Class	Product Code
§870.2870	Transducer, Pressure, Catheter Tip	Class 2	DXO