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About This Item

 

Full Description

BS EN 60601-2-66:2015 applies to the BASIC SAFETY of HEARING INSTRUMENTS and HEARING INSTRUMENT SYSTEMS, hereafter also referred to as ME EQUIPMENT or ME SYSTEM.

If a clause or subclause is specifically intended to be applicable to HEARING INSTRUMENTS only, or to HEARING INSTRUMENT SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to HEARING INSTRUMENTS and to HEARING INSTRUMENT SYSTEMS, as relevant.

HAZARDS inherent in the intended physiological function of HEARING INSTRUMENTS or HEARING INSTRUMENT SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 201.7.9.2 and 201.9.6.


Cross References:
IEC 60950-1:2005
IEC 60950-1:2005+A1:2009
IEC 60950-1:2005+A2:2013
IEC 60118-0:2015
IEC 60118-13
IEC 60601-1:2015
IEC 60601-1:2015+A1:2012
IEC 60601-1-11:2015
IEC 62304
IEC 62366:2007
EN 60950-1:2006
EN 60950-1:2006+AC:2011
EN 60950-1:2006+A11:2009
EN 60950-1:2006+A1:2010
EN 60950-1:2006+A12:2011
EN 60950-1:2006+A2:2013
EN 60118-0:2015
EN 60118-13
EN 60601-1:2006
EN 60601-1:2006+A1:2013
EN 60601-1:2006+A1/AC:2014
EN 60601-1:2006+A12:2014
EN 60601-1-11:2015
EN 62304
EN 62366:2008


All current amendments available at time of purchase are included with the purchase of this document.
 

Document History

  1. BS EN IEC 60601-2-66:2020


    Medical electrical equipment-Particular requirements for the basic safety and essential performance of hearing aids and hearing aid systems

    • Most Recent
  2. BS EN 60601-2-66:2015

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    Medical electrical equipment-Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems

    • Historical Version
  3. BS EN 60601-2-66:2013


    Medical electrical equipment-Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems

    • Historical Version
  4. BS 10/30240267 DC


    BS EN 60601-2-66. Electroacoustics. Part 2-66. Hearing instruments and hearing systems. General requirements for basic safety and essential performance

    • Historical Version