Recognized Consensus Standards

Recognition List Number: 024 Publication Date: 06/10/2010

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 4-187: IEC 60601-2-18: Edition 3.0 2009-08, Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment. (Dental/ENT)

Date of Standard: 2009.

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)

Devices Affected:

Endoscopes and accessories (but not including laser accessories)

Processes Affected:

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

Type of Standard:

Vertical, International

Extent of Recognition:

Standard covers electrical, mechanical and other safety characteristics and labeling details important for safety (such as warnings). These parameters and labels must be included in premarket submissions and must be adhered to if devices are exempt from premarket notification.

Transition:
FDA Recognition of Edition 2:2001 of IEC 60601-1 is hereby superseded by recognition of ANSI/AAMI ES60601-1:2005, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. FDA will accept declaration of conformity, in support of premarket submissions, to IEC 60601-1:2001 until June 30, 2013. After this transitional period, declaration of conformity to Edition 2:2001 of the standard will not be accepted.

Related CFR Citations and Product Codes:

Regulation Number	Device Name	Device Class	Product Code
§874.4350	Source, Carrier, Fiberoptic Light	Class 1	EQH

Regulation Number	Device Name	Device Class	Product Code
§874.4680	Bronchoscope (Flexible Or Rigid)	Class 2	EOQ

Regulation Number	Device Name	Device Class	Product Code
§874.4710	Esophagoscope (Flexible Or Rigid)	Class 2	EOX

Regulation Number	Device Name	Device Class	Product Code
§874.4720	Mediastinoscope, Surgical	Class 2	EWY

Regulation Number	Device Name	Device Class	Product Code
§874.4750	Laryngostroboscope	Class 1	EQL

Regulation Number	Device Name	Device Class	Product Code
§874.4760	Nasopharyngoscope (Flexible Or Rigid)	Class 2	EOB

Regulation Number	Device Name	Device Class	Product Code
§874.4770	Otoscope	Class 1	ERA