Recognition List Number: 029 Publication Date: 08/20/2012
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 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 |
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SWITZERLAND
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| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF DEVICE EVALUATION (ODE) |
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| Devices Affected: |
Total joint replacements (e.g., hip, knee, shoulder, finger, etc.)
Dental implants and abutments |
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| Processes Affected: |
| 510(k), PMA, IDE, PDP, HDE, Design Control Input, Quality System Regulation |
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| Type of Standard: |
| Horizontal, International |
| Extent of Recognition: |
Complete standard.
This is not a performance standard. The testing proposed to meet this standard must still be reviewed and evaluated against FDA requirements for safety and efficacy. |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §872.3630 |
Abutment, Implant, Dental, Endosseous |
Class 2 |
NHA |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §872.3640 |
Implant, Endosseous, Root-Form |
Class 2 |
DZE |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §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 |
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| Relevant Guidance: |
Extraction Guidance for Polymeric Materials, Chemistry Group, FDA/CDRH/OSEL/DCMS
ISO 10993-12:2007: Biological Evaluation of Medical Devices -- Part 12: Sample preparation and reference materials
For further guidance, see FDA Bluebook Memorandum G95-1 "Use of International Standard ISO 10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing'." |
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| 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 |
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| * 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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