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Public comments sought on proposed national standard for cochlear implant systems

Friday, October 3, 2014  
Posted by: Susan Thomas
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OPPORTUNITY FOR PUBLIC COMMENT AND REVIEW OF PROPOSED NATIONAL STANDARD ON SAFETY, PERFORMANCE, AND RELIABILITY OF COCHLEAR IMPLANT SYSTEMS

 

The Association for the Advancement of Medical Instrumentation (AAMI) recently posted the following document on their website:  AAMI/CI86:201x:  Cochlear Implant Systems – Safety, Performance, and Reliability.  The AAMI is seeking public comments by November 3, 2014.   This document represents a voluntary standard for cochlear implants.  Some of the topics covered in this proposed standard include:   

 

  • Information that should be provided with or on the product (packaging and labeling)
  • Basic safety and performance criteria that should be considered in qualifying the device for clinical use
  • Measurement techniques that can be used to determine whether the device conforms with the safety and performance criteria and to determine device reliability and malfunction
  • Reliability and malfunction reporting.

 

The standard was developed by the AAMI Cochlear Implant Committee and has been released for public review. Comments are due November 3, 2014.  You may access the document here:https://standards.aami.org/kws/public/document?document_id=4383&wg_abb

 

Interested parties may submit public review comments, in writing, using the comment template located at:

https://standards.aami.org/kws/public/document?document_id=4382&wg_abbrev=PUBLIC_REV

 

Send comments to:

ATTN: Colleen Elliott

Email: celliott@aami.org

AAMI

4301 N Fairfax Dr

Ste 301

Arlington, VA 22203-1633

 


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