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NS-BPMW1
www.insigniaproducts.com
30
EMC guidance
The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare
environments.
• Warning: Don’t use near active HF surgical equipment and the RF
shielded room of an ME system for magnetic resonance imaging,
where the intensity of EM disturbances is high.
• Warning: Use of this equipment adjacent to or stacked with other
equipment should be avoided because it could result in improper
operation. If such use is necessary, this equipment and the other
equipment should be observed to verify that they are operating
normally.
• Warning: Use of accessories, transducers, and cables other than
those specified or provided by the manufacturer of this equipment
could result in increased electromagnetic emissions or decreased
electromagnetic immunity of this equipment and result in improper
operation.
Usability • EN 60601-1-6:2010+A1:2015/IEC
60601-1-6:2010+A1:2013 Medical electrical
equipment - Part 1-6: General requirements for basic
safety and essential performance - Collateral
standard: Usability
• IEC 62366-1:2015 Medical devices - Part 1:
Application of usability engineering to medical
devices
Software
life-cycle
processes
• EN 62304:2006/AC: 2008 / IEC 62304: 2006+A1:2015
Medical device software - Software life-cycle
processes
Bio-
compatibility
• ISO 10993-1:2009 Biological evaluation of medical
devices- Part 1: Evaluation and testing within a risk
management process
• ISO 10993-5:2009 Biological evaluation of medical
devices - Part 5: Tests for in vitro cytotoxicity
• ISO 10993-10:2010 Biological evaluation of medical
devices - Part 10: Tests for irritation and skin
sensitization
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