Recognized Consensus Standards

Recognition List Number: 030 Publication Date: 01/15/2013

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 9-80: IEC 60601-2-16 Edition 4.0 2012-03, Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemonfiltration equipment . (ObGyn/Gastroenterology)

Date of Standard: 2012.

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:

Hemodialysis Systems, High Permeability Hemodialysis Systems

Processes Affected:

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

Type of Standard:

Vertical, International

Extent of Recognition:

Complete Standard

Transition:
FDA recognition of IEC 60601-2-16 (1998) is hereby superseded by recognition of ANSI/AAMI/IEC 60601-2-16 (Third edition - 2008), Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment CORRIGENDUM 1. FDA will accept declarations of conformity, in support of premarket submissions, to IEC 60601-2-16 (1998) until June 30, 2013. After this transitional period, declaration of conformity to IEC 60601-2-16 (1998) will not be accepted.

Similarly, FDA recognition of ANSI/AAMI RD 5:2003/(R)2008 Hemodialysis systems, is superseded by recognition of ANSI/AAMI/IEC 60601-2-16 (Third edition - 2008), Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment CORRIGENDUM 1. ANSI/AAMI RD 5:2003/(R)2008 Hemodialysis systems, has been withdrawn by ANSI/AAMI.

Related CFR Citations and Product Codes:

Regulation Number	Device Name	Device Class	Product Code
§876.5820	System, Dialysate Delivery, Single Patient	Class 2	FKP
§876.5860	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Class 2	KDI

Relevant Guidance:

Regulatory Status of Disinfectants Used to Process Dialysate Delivery Systems and Water Purification Systems for Hemodialysis; Guidance for Industry and FDA. Issued on August 30, 2002

Guidance for Industry and CDRH Reviewers-Guidance for the Content of Premarket Notifications for Hemodialysis Delivery Systems. Issued August 7, 1998

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

Gema Gonzalez

FDA/CDRH/ODE

10903 New Hampshire Avenue Building 66, Room G220

Silver Spring MD 20993

301/796-6519