• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 040 Date of Recognition 08/14/2015 
FR Recognition Number 9-101
Standard
ISO 26722 Second edition 2014-04-01
Water treatment equipment for hemodialysis applications and related therapies
U.S. Identical Adoption
ANSI AAMI ISO 26722:2014
Water treatment equipment for haemodialysis applications and related therapies
Scope/Abstract
ISO 26722:2014 is addressed to the manufacturer and/or supplier of water treatment systems and/or devices used for the express purpose of providing water for haemodialysis or related therapies.

ISO 26722:2014 covers devices used to treat water intended for use in the delivery of haemodialysis and related therapies, including water used for: (1) the preparation of concentrates from powder or other highly concentrated media at a dialysis facility; (2) the preparation of dialysis fluid, including dialysis fluid that can be used for the preparation of substitution fluid; (3) the reprocessing of dialysers for multiple uses.

Included within the scope of ISO 26722:2014 are all devices, piping and fittings between the point at which potable water is delivered to the water treatment system, and the point of use of the dialysis water. Examples of devices included within the scope of ISO 26722:2014 are water purification devices, online water quality monitors (such as conductivity monitors), and piping systems for the distribution of dialysis water.

Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§876.5665 Subsystem, Water Purification Class 2 FIP
Relevant FDA Guidance and/or Supportive Publications
Regulatory Status of Disinfectants Used to Process Dialysate Delivery Systems and Water Purification Systems for Hemodialysis; Guidance for Industry and FDA, Issued August 2002.
FDA Technical Contacts
 Richard J. Williams
  FDA/OMPT/CDRH/ODE/DRGUD/RNDB/
  301-796-6528
  richard.williams@fda.hhs.gov
 Gema Gonzalez
  FDA/OMPT/CDRH/ODE/DRGUD/RNDB/
  301-796-6519
  gema.gonzalez@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
ObGyn/Gastroenterology/Urology
-
-