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

Part B: Supplementary Information

Recognition Number 2-165: AAMI / ANSI / ISO 10993-14:2001/(R) 2011, biological evaluation of medical devices - part 14: identification and quantification of degradation products form ceramics. (Biocompatibility)

Date of Standard: 2001. 
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:
Devices Affected:
Total joint replacements (e.g., hip, knee, shoulder, finger, etc.)
Dental implants and abutments
Processes Affected:
510(k), PMA, IDE, PDP, HDE, De Novo
Type of Standard:
 Horizontal, International
Extent of Recognition:
Complete standard.
Related CFR Citations and Product Codes:
Device Name Device
§872.3630 Abutment, Implant, Dental, Endosseous Class 2 NHA
§872.3640 Implant, Endosseous, Root-Form Class 2 DZE
§888.3353 Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Class 2 LZO
§888.3353 Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate Class 2 MEH
Relevant Guidance:
ISO 10993-12:2012 Biological Evaluation of Medical Devices -- Part 12: Sample preparation and reference materials.

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

FDA Draft Guidance "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" which, when final, will represent the Agency's thinking on this topic.
FDA Technical Contact:
 Scott McNamee
  10903 New Hampshire Avenue WO66, RM416
  Silver Spring MD 20993
  email: scott.mcnamee@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