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U.S. Department of Health and Human Services

Recognized Consensus Standards

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

Part B: Supplementary Information

Recognition Number 17-9: ASTM F2129-08, standard test method for conducting cyclic potentiodynamic polarization measurements to determine the corrosion susceptibility of small implant devices. (Neurology)

Date of Standard: 2008. 
Address of Standards Development Organization:
 ASTM International (ASTM)
  100 Barr Harbor Drive
  West Conshohocken, PA 19428-2959
 
CDRH Office and Division associated with recognized standards:
OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Small metallic neurologic implants
Processes Affected:
510(k), PMA, PDP, IDE, HDE, Design Control Input, Quality System Regulation
Type of Standard:
 National, Horizontal, Test Methods
Extent of Recognition:
Complete standard and any annexes
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§882.5200 Clip, Aneurysm Class 2 HCH
Relevant Guidance:
Guidance for Testing MR Interactive with Aneurysm Clips, Draft Document - May 22, 1996

Guidance for Industry and FDA Staff Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment, August 21, 2008

USP 35-NF30: 2012, <85> Bacterial Endotoxins Test

USP 35-NF30:2012 <151> Pyrogen Test

ANSI/AAMI ST72:2011 Bacterial endotoxins ¿ Test methods, routine monitoring, and alternative to batch testing

FDA Guidance for Industry Pyrogens and Endotoxins Testing: Questions and Answers, June 2012

AAMI/ANSI/ISO 10993-1:2009 Biological Evaluation of Medical Devices ¿ Part 1: Evaluation and Testing within a Risk Management Process

AAMI/ANSI/ISO 10993-3:2003/(R)2009 Biological Evaluation of Medical Devices ¿ Part 3: Tests for Genotoxicity, Carcinogenicity, and Reproductive Toxicity

AAMI/ANSI/ISO 10993-5:2009 Biological Evaluation of Medical Devices ¿ Part 5: Tests for In Vitro Cytotoxicity

AAMI/ANSI/ISO 10993-6:2007/(R)2010 Biological Evaluation of Medical Devices ¿ Part 6: Tests for Local Effects after Implantation

AAMI/ANSI/ISO 10993-7:2008/(R)2012 Biological Evaluation of Medical Devices ¿ Part 7: Ethylene Oxide Sterilization Residuals

AAMI/ANSI/ISO 10993-10: 2010 Biological Evaluation of Medical Devices ¿ Part 10: Tests for Irritation and Skin Sensitization

AAMI/ANSI/ISO 10993-11:2006/(R)2010 Biological Evaluation of Medical Devices ¿ Part 11: Tests for Systemic Toxicity
FDA Technical Contact:
 Jeffrey Toy, Ph.D.
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 2459
  Silver Spring MD 20993
  301/796-6610
  email: jeffrey.toy@fda.hhs.gov
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