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U.S. Department of Health and Human Services

Recognized Consensus Standards
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Recognition List Number: 028 Publication Date: 03/16/2012 

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 17-7: ISO 7197:2006 Technical Corrigendum1:2007, Neurological implants - Sterile, single-use hydrocephalus shunts and components. (Neurology)

Date of Standard: 2006. 
Address of Standards Organization:
  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:
Sterile, single use hydrocephalus shunts and components including:
a. one piece type
b. multiple types either assembled or in kit form
c. individual shunt components or in combination
Processes Affected:
510(k), IDE, PMA, PDP, HDE
Type of Standard:
 Vertical, International, Test Methods
Extent of Recognition:
Complete Technical Corrigendum 1
Related CFR Citations and Product Codes:
Regulation
Number		 Device Name Device
Class		 Product
Code
§882.4060 Cannula, Ventricular Class 1 HCD
 
Regulation
Number		 Device Name Device
Class		 Product
Code
§882.4100 Catheter, Ventricular Class 2 HCA
 
Regulation
Number		 Device Name Device
Class		 Product
Code
§882.4545 Instrument, Shunt System Implantation Class 1 GYK
 
Regulation
Number		 Device Name Device
Class		 Product
Code
§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 Parental Drugs, Biological Products, and Medical Devices. Document issued prior to February 1997.
FDA Technical Contact:
  Joseph C. Hutter
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 2458
  Silver Spring MD 20993
  301/796-6499
  Email: joseph.hutter@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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