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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
  SWITZERLAND
CDRH Office and Division associated with recognized standards:
OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Total joint replacements (e.g., hip, knee, shoulder, finger, etc.)
Dental implants and abutments
Processes Affected:
510(k), PMA, IDE, PDP, HDE, Design Control Input, Quality System Regulation
Type of Standard:
 Horizontal, International
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§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:
Extraction Guidance for Polymeric Materials, Chemistry Group, FDA/CDRH/OSEL/DCMS

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FDA Draft Guidance "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" which, when final, will represent the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
  FDA/CDRH/OC
  10903 New Hampshire Avenue Building 66, Room 3416
  Silver Spring MD 20993
  301/796-5800
  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
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