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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 051 Date of Entry 01/14/2019 
FR Recognition Number 9-121
Standard(Included in ASCA pilot)
IEC 60601-2-16 Edition 5.0 2018-4
Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemonfiltration equipment
U.S. Identical Adoption
ANSI AAMI IEC 60601-2-16:2018
Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
Scope/Abstract
The testing in this standard applies to the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment. IEC 60601-2-16 testing does not take into consideration the dialysis fluid control system of haemodialysis equipment using regeneration of dialysis fluid and central delivery systems. It does however take into consideration the specific safety requirements of such haemodialysis equipment concerning electrical safety and patient safety.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
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 FDA Guidance and/or Supportive Publications*
AAMI CR500:2019 Basic Introduction to the IEC 60601 Series.

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

Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis, Issued May 1997.
FDA Technical Contacts
 Carolyn Neuland
  FDA/OC/CDRH/OPEQ/OHTIII/DHTIIIA/
  301-796-6523
  carolyn.neuland@fda.hhs.gov
 Gema Gonzalez
  FDA/OC/CDRH/OPEQ/OHTIII/DHTIIIA/
  301-796-6519
  gema.gonzalez@fda.hhs.gov
Standards Development Organization
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
ObGyn/Gastroenterology/Urology
*These are provided as examples and others may be applicable.
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