• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 

New Search Back To Search Results
Recognition List Number: 034 FR Publication Date: 01/30/2014 

Part B: Supplementary Information

Recognition Number 9-73: AAMI / ANSI / ISO 13958:2009, concentrates for hemodialysis and related therapies. (ObGyn/Gastroenterology)

Date of Standard: 2009. 
Addresses of Standards Development Organizations:
 Association for the Advancement of Medical Instrumentation (AAMI)
  4301 North Fairfax Drive
  Suite 301
  Arlington, VA 22203
 
 American National Standards Institute (ANSI)
  25 West 43rd Street
  4th Floor
  New York, NY 10036
 
 International Organization for Standardization (ISO)*
  1, Rue de Varembe
  Case Postale 56
  CH 1211 Geneva 20, 0
  SWITZERLAND
CDRH Office and Division associated with recognized standards:
OFFICE OF DEVICE EVALUATION (ODE)
DIVISION OF REPRODUCTIVE, GASTRORENAL AND UROLOGY DEVICES (DRGUD)
Devices Affected:
Dialysate Concentrates
Processes Affected:
510(k), PMA, PDP, IDE, HDE, Quality System Regulations
Type of Standard:
 Vertical, National
Extent of Recognition:
Complete standard with the following exceptions:

Section 5.2.10 is not recognized

Section 5.4.2 is not recognized
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§876.5820 Dialysate Concentrate For Hemodialysis (Liquid Or Powder) Class 2 KPO
Relevant Guidance:
Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis. Issued May 30, 1997.

Regulatory Status of Disinfectants Used to Process Dialysate Delivery Systems and Water Purification Systems for Hemodialysis; Guidance for Industry and FDA. Issued August 30, 2002.
FDA Technical Contact:
 Frank Hurst
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room G217
  Silver Spring MD 20993
  301/796-5968
  email: frank.hurst@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
-
-