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Recognized Consensus Standards

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Recognition List Number: 034 FR Publication Date: 01/30/2014 

Part B: Supplementary Information

Recognition Number 9-92: ISO 8637 Third edition 2010-07-01, cardiovascular implants and extracorporeal systems - hemodialyzers, hemodiafilters, hemofilters, and hemoconcentrators [including: amendment 1 (2013)]. (ObGyn/Gastroenterology)

Date of Standard: 2010. 
Address of Standards Development Organization:
 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)
Devices Affected:
Hemodialyzers, Hemoconcentrators, Hemofilters, Hemodiafilters
Processes Affected:
510(k), PMA, PDP, IDE, HDE, Quality System Regulations
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete standard with the following exceptions:

Section 6.1 NOTE is not recognzed

Section 6.2 e is not recognized

Section 6.2 NOTE is not recognized

Section 6.3 NOTE is not recognized

Section 6.4 Third NOTE is not recognized.

For Sections 4.5.1, 4.5.2, 4.5.3, and 5.6.5.3, the Guidance for Industry and CDRH Reviewers, Guidance for the Content of Premarket Notifications for Conventional and High Permeability Hemodialyzers, issued on August 7, 1998, should be consulted for more specific recommendations.

For Section 5.2, FDA Blue Book Memorandum #G95-1: Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," should be consulted for more specific recommendations.
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§876.5820 Dialyzer, Capillary, Hollow Fiber Class 2 FJI
§876.5820 Dialyzer, Parallel Flow Class 2 FJG
§876.5820 Dialyzer, Single Coil Class 2 FHS
§876.5820 Dialyzer, Twin Coil Class 2 FJJ
§876.5820 Filter, Blood, Dialysis Class 2 FKJ
§876.5860 Dialyzer, High Permeability With Or Without Sealed Dialysate System Class 2 KDI
Relevant Guidance:
Guidance for Industry and CDRH Reviewers, Guidance for the Content of Premarket Notifications for Conventional and High Permeability Hemodialyzers. Issued on August 7, 1998.

FDA Blue Book Memorandum #G95-1: Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing."
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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