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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 17-1: AAMI NS28:1988/(R) 2010, intracranial pressure monitoring devices. (Neurology)

Date of Standard: 1988. 
Address of Standards Development Organization:
 Association for the Advancement of Medical Instrumentation (AAMI)
  4301 North Fairfax Drive
  Suite 301
  Arlington, VA 22203
 
CDRH Office and Division associated with recognized standards:
OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Intracranial Pressure (ICP) Monitors
Processes Affected:
510(k), PMA, IDE, PDP, HDE
Type of Standard:
 National, Vertical
Extent of Recognition:
Complete Standard with the following exceptions:

Clause 3.2.11 is not recognized

Notes in Clause 3.1.2.2(2) is not recognized

A3.1.1 is not recognized

A3.1.2 is not recognized
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§882.1620 Device, Monitoring, Intracranial Pressure Class 2 GWM
Relevant Guidance:
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.

Guidance for Industry and FDA Staff Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. Document issued on: May 11, 2005

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:
 Xiaolin Zheng, Ph.D.
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 2431
  Silver Spring MD 20993
  301/796-2823
  email: xiaolin.zheng@fda.hhs.gov
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