Recognized Consensus Standards

Recognition List Number: 028 Publication Date: 03/16/2012 

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 9-61: 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. (ObGyn/Gastroenterology)

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 (GI/GU), Colposcope, Culdoscope, Hysteroscope, Falloposcope, Gynecologic Laparoscope, Breast Ductoscope

Processes Affected:

510(k), PMA, PDP, IDE, HDE, GMP, Design Controls

Type of Standard:

 Vertical, International

Extent of Recognition:

Complete Standard

Transition:

FDA recognition of IEC 60601-2-18 (1996) Amendment 1 2000 is hereby superseded by recognition of IEC 60601-2-18 Edition 3.0 2009-08, Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance endoscopic equipment. FDA will accept declaration of conformity, in support of premarket submissions to IEC 60601-2-18 (1996) Amendment 1 2000 unitl June 30, 2013. After this transitional period, declaration of conformity to IEC 60601-2-18 (1996) Amendment 1 2000 will not be accepted.

Related CFR Citations and Product Codes:

Regulation Number	Device Name	Device Class	Product Code
Unclassified	Ductoscope, Breast	Class U	MMN
Unclassified	Falloposcope	Class U	MKO
Regulation Number	Device Name	Device Class	Product Code
§876.1500	Angioscope	Class 2	LYK
§876.1500	Anoscope And Accessories	Class 2	FER
§876.1500	Choledochoscope And Accessories, Flexible/Rigid	Class 2	FBN
§876.1500	Colonoscope And Accessories, Flexible/Rigid	Class 2	FDF
§876.1500	Cystoscope And Accessories, Flexible/Rigid	Class 2	FAJ
§876.1500	Cystourethroscope	Class 2	FBO
§876.1500	Duodenoscope And Accessories, Flexible/Rigid	Class 2	FDT
§876.1500	Endoscope And/Or Accessories	Class 2	KOG
§876.1500	Endoscope, Flexible	Class 2	GCQ
§876.1500	Endoscope, Rigid	Class 2	GCM
§876.1500	Enteroscope And Accessories	Class 2	FDA
§876.1500	Laparoscope, General & Plastic Surgery	Class 2	GCJ
§876.1500	Resectoscope	Class 2	FJL
§876.1500	Sigmoidoscope And Accessories, Flexible/Rigid	Class 2	FAM
§876.1500	Sigmoidoscope, Rigid, Electrical	Class 2	FAN
§876.1500	Telescope, Rigid, Endoscopic	Class 2	FBP
§876.1500	Ureteroscope And Accessories, Flexible/Rigid	Class 2	FGB
§876.1500	Urethroscope	Class 2	FGC
Regulation Number	Device Name	Device Class	Product Code
§884.1630	Colposcope (And Colpomicroscope)	Class 2	HEX
§884.1630	Vaginoscope And Accessories	Class 2	MOK
Regulation Number	Device Name	Device Class	Product Code
§884.1640	Culdoscope (And Accessories)	Class 2	HEW
Regulation Number	Device Name	Device Class	Product Code
§884.1690	Hysteroscope (And Accessories)	Class 2	HIH
Regulation Number	Device Name	Device Class	Product Code
§884.1720	Laparoscope, Gynecologic (And Accessories)	Class 2	HET

Relevant Guidance:

Hysteroscopes and Gynecologic Laparoscopes Submission Guidance for a 510(k). Issued March 7, 1996.

FDA Technical Contacts:

Carolyn Neuland   FDA/CDRH/ODE   10903 New Hampshire Avenue Building 66, Room G226   Silver Spring MD 20993   301/796-6523   Email: carolyn.neuland@fda.hhs.gov

Janine Morris   FDA/CDRH/ODE   10903 New Hampshire Avenue Building 66, Room G208   Silver Spring MD 20993   301/796-5706   Email: janine.morris@fda.hhs.gov

Colin M. Pollard   FDA/CDRH/ODE   10903 New Hampshire Avenue Building 66, Room G108   Silver Spring MD 20993   301/796-6537   Email: colin.pollard@fda.hhs.gov

* In the United States, copies of this standard can be obtained from:

  American National Standards Institute (ANSI)*

  25 West 43rd Street

  4th Floor

  New York, NY 10036