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

Part B: Supplementary Information

Recognition Number 2-170: ISO 10993-14 First edition 2001-11-15, biological evaluation of medical devices - part 14: identification and quantification of degradation products from ceramics. (Biocompatibility)

Date of Standard: 2001. 
Address of Standards Development Organization:
 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 replacement (e.g., hip, knee, shoulder, finger, etc.)
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:
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:
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FDA Draft Guidance "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" which, when final, will represent the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
  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