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Recognized Consensus Standards

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

Part B: Supplementary Information

Recognition Number 9-81: AAMI / ANSI / ISO 60601-2-16 :2012, medical electrical equipment - part 2-16: particular requirements for basic safety and essential performance of hemodialysis, hemodiafiltration and hemofiltration equipment. (ObGyn/Gastroenterology)

Date of Standard: 2012. 
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
 
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, National
Extent of Recognition:
Complete standard.

Transition:
FDA recognition of IEC 60601-2-16 (1998) is hereby superseded by recognition of ANSI/AAMI/IEC 60601-2-16:2012 , Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment. FDA will accept declarations of conformity, in support of premarket submissions, to IEC 60601-2-16: 2008 until December 31, 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Similarly, FDA recognition of ANSI/AAMI RD 5:2003/(R)2008 Hemodialysis systems, is superseded by recognition of ANSI/AAMI/IEC 60601-2-16 (Third edition - 2008), Medical electrical equipment - Part 2-16: Particular requirements for basic safety and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 ANSI/AAMI RD 5:2003/(R)2008 Hemodialysis systems, has been withdrawn by ANSI/AAMI.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
  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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