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About This Item

 

Full Description

BS EN 60601-1-11:2015 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS for use in the HOME HEALTHCARE ENVIRONMENT, as defined in 3.1, and specified by the MANUFACTURER in the instructions for use. This International Standard applies regardless of whether the ME EQUIPMENT or ME SYSTEM is intended for use by a LAY OPERATOR or by trained healthcare personnel.


Cross References:
CISPR 11:2009
IEC 60068-2-27:2008
IEC 60068-2-31:2008
IEC 60068-2-64:2008
IEC 60529:1989
IEC 60529:1989/AMD1:1999
IEC 60529:1989/AMD2:2013
IEC 60601-1:2005
IEC 60601-1:2005/AMD1:2012
IEC 60601-1-2:2014
IEC 60601-1-6:2010
IEC 60601-1-6:2010/AMD1:2013
IEC 60601-1-8:2006
IEC 60601-1-8:2006/AMD1:2012
IEC 60601-1-12:2014
IEC 62366:2007
IEC 62366:2007/AMD1:2014
ISO 7000
ISO 7010:2011
ISO 7010:2011/AMD1:2012
ISO 7010:2011/AMD2:2012
ISO 7010:2011/AMD3:2012
ISO 7010:2011/AMD4:2013
ISO 7010:2011/AMD5:2014
ISO 15223-1:2012
EN 60068-2-27:2009
EN 60068-2-31:2008
EN 60068-2-64:2008
EN 60529:1991
EN 60529:1991/A1:2000
EN 60529:1991/A2:2013
EN 60601-1:2006
EN 60601-1:2006/A1:2013
EN 60601-1:2006/A12:2014
EN 60601-1-2:2014
EN 60601-1-6:2010
EN 60601-1-6:2010/A1:2015
EN 60601-1-8:2007
EN 60601-1-8:2007/A1:2013
EN 60601-1-12:2015
EN 62366:2008
EN 62366:2008/A1:2015
EN 55011:2009
EN ISO 7010:2012
EN ISO 7010:2012/A1:2014
EN ISO 7010:2012/A2:2014
EN ISO 7010:2012/A3:2014
EN ISO 7010:2012/A4:2014
EN ISO 7010:2012/A5:2015
EN ISO 15223-1:2012
93/42/EEC
IEC 60038:2009
IEC 60065:2014
IEC 60335-1:2010
IEC 60364
IEC 60601-1-9
IEC 60721-3-7:1995
EN 60038:2011
EN 60065:2014
EN 60335-1:2012
HD 384
HD 60364
EN 60601-1-9
EN 60721-3-7:1995
IEC 60950-1:2005
IEC 60950-1:2005/A1:2009
IEC 60950-1:2005/A2:2013
IEC 61032:1997
ISO 10651-2:2004
EN 60950-1:2006
EN 60950-1:2006/A1:2010
EN 60950-1:2006/A2:2013
EN 61032:1998
EN ISO 10651-2:2009
ASTM F2020-02
EN 13718-1:2008
MIL-STD-810F(3):2003
MIL-HDBK-310


Replaces BS EN 60601-1-11:2010 which remains current.

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

Document History

  1. BS EN 60601-1-11:2015

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    Medical electrical equipment. General requirements for basic safety and essential performance. Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

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  2. BS EN 60601-1-11:2010


    Medical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

    • Historical Version