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ISO 80601-2-12:2011 / IEC 60601-2-12: 2001 (EN 60601-2-12:2006) - Medical electrical
equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care
ventilators
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ISO 5359:2008/Amd 1:2011 (EN ISO 5359:2008+A1:2011) - Low-pressure hose assemblies for
use with medical gases
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NBR IEC 60601-1-2 (2017) / IEC 60601-1-2(2014) / (EN IEC 60601-1-2:2015) - Medical electrical
equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral
standard: Electromagnetic compatibility - Requirements and tests
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IEC 62304:2006 +AMD1:2015 (EN 62304:2006/2008) - Medical device software - Software life-
cycle processes
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IEC 60601-1-8 Ed. 2.0 (2006)/A1:2012 (EN 60601-1-8:2007/A11:2017) - Medical electrical
equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral
Standard: General requirements, tests and guidance for alarm systems in medical electrical
equipment and medical electrical systems
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IEC 60601-1-4: 1996/A1:1999 (EN 60601-1-4: 1996/A1: 1999) - Medical electrical equipment -
Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical
systems
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IEC 60601-1-6: 2010 (EN 60601-1-6:2010) - Medical electrical equipment - Part 1-6: General
requirements for basic safety and essential performance - Collateral standard: Usability
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IEC 62366: 2007 (EN 62366:2008) - Medical devices - Application of usability engineering to
medical devices
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EN ISO 17665-1:2006 - Sterilization of health care products - Moist heat - Part 1: Requirements
for the development, validation and routine control of a sterilization process for medical devices
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EN ISO 17664:2004 - Sterilization of medical devices - Information to be provided by the
manufacturer for the processing of resterilizable medical devices
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EN 1041:2008 - Information supplied by the manufacturer of medical devices
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ISO 15223-1: 2016 (EN ISO 15223-1:2016) - Medical devices - Symbols to be used with medical
device labels, labelling and information to be supplied - Part 1: General requirements
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ISO 80601-2-61:2011 (EN ISO 80601-2-61:2011) – Medical electrical equipment: Particular
requirements for basic safety and essential performance of pulse ox equipment
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ISO 80601-2-55:2011 (EN 80601-2-55: 2011) - Medical electrical equipment -- Part 2-55:
Particular requirements for the basic safety and essential performance of respiratory gas monitors
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SO 780:2015 – Packaging -- Distribution packaging -- Graphical symbols for handling and storage
of packages
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