Recognized Consensus Standards

Recognition List Number: 020 Publication Date: 09/09/2008

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 3-65: AAMI / ANSI EC38:2007, Medical electrical equipment - Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems. (Cardiovascular)

Date of Standard: 2007.

Addresses of Standards Organizations:

Association for the Advancement of Medical Instrumentation (AAMI)

4301 North Fairfax Drive

Suite 301

Arlington, VA 22203

American National Standards Institute (ANSI)

25 West 43rd Street

4th Floor

New York, NY 10036

CDRH Office and Division Associated with Recognized Standards:

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

Devices Affected:

Ambulatory electrocardiographs

Processes Affected:

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

Type of Standard:

Test Method & Device Specification, National, Vertical

Extent of Recognition:

Complete Standard (except as noted below).

Clause 4.2.7.1, System noise, is not recognized.
Clause 4.2.7.5, Overall system error, is not recognized.
Clause 5.2.7.5, Overall system error, is not recognized.

NOTE: Cables and leadwires must meet the FDA mandatory standard 21 CFR 898.12.

There is a typographical error in clause 4.2.1.2, Figure 1. The 2 in the unit (G₂Hz) should be a subscript.

Related CFR Citations and Product Codes:

Regulation Number	Device Name	Device Class	Product Code
§870.2300	Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)	Class 2	MWI

Regulation Number	Device Name	Device Class	Product Code
§870.2800	Electrocardiograph, Ambulatory, With Analysis Algorithm	Class 2	MLO