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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 17-4: ASTM F647-94 (Reapproved 2006), standard practice for evaluating and specifying implantable shunt assemblies for neurosurgical application. (Neurology)

Date of Standard: 1994. 
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:
Devices Affected:
Neurological Shunt Assemblies for Neurological Applications
Processes Affected:
510(k), PMA, IDE, PDP, HDE
Type of Standard:
 Test Methods, Vertical, National
Extent of Recognition:
Complete Standard with the following exception:

Clause 5.3 is not recognized.
Related CFR Citations and Product Codes:
Device Name Device
§882.4060 Cannula, Ventricular Class 1 HCD
§882.4100 Catheter, Ventricular Class 2 HCA
§882.4545 Instrument, Shunt System Implantation Class 1 GYK
§882.5550 Shunt, Central Nervous System And Components Class 2 JXG
Relevant Guidance:
Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices May 1, 1995 (G95-1)

Guideline on Validation of the LAL Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices. Document issued prior to February 1997.

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

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

ISO 10993-1:2009 Biological evaluation of medical devices ¿ Part 1: Evaluation and testing within a risk management process
FDA Technical Contact:
 Samuel Shimp
  10903 New Hampshire Avenue Building 66, Room 1430
  Silver Spring MD 20993
  email: samuel.shimp@fda.hhs.gov