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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 17-12: ISO 7197 Third edition 2006-06-01, neurosurgical implants - sterile, single-use hydrocephalus shunts and components [including: technical corrigendum 1 (2007)]. (Neurology)

Date of Standard: 2006. 
Address of Standards Development 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. multipiece type either assembled or in kit form,
c. individual shunt components or in combination.
Processes Affected:
510(k), PMA, IDE, PDP, HDE
Type of Standard:
 Vertical, International, Test Methods
Extent of Recognition:
Complete standard and any annexes
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§882.4060 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
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 1430
  Silver Spring MD 20993
  301/796-6610
  email: samuel.shimp@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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