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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 031 FR Publication Date: 08/05/2013 

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 Development Organization:
 International Electrotechnical Commission (IEC)
  3, Rue de Varembe'
  PO Box 131
  CH-1211 Geneva 20, 0
 
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

Similarly, FDA recognition of ANSI/AAMI RD 5:2003/(R)2008 Hemodialysis systems, is superseded by recognition of ANSI/AAMI/IEC 60601-2-16 (Third edition - 2008), Medical electrical equipment - Part 2-16: Particular requirements for basic safety and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 ANSI/AAMI RD 5:2003/(R)2008 Hemodialysis systems, has been withdrawn by ANSI/AAMI.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
  email: gema.gonzalez@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
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