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Brodie C. Pedersen
Brodie.Pedersen@LogicPD.com
Goals
Address environments of use outside the hospital
Home (See IEC 60601-1-11:2015)
EMS (See IEC 60601-1-12:2014)
These environments have reduced capability to control the EM
environment and a reduced level of medical supervision.
To cover the Basic Safety and Essential Performance of ME Equipment in
the expected EM Environment
Since the EM environment can be compared to temperature and
humidity it is considered a normal condition.
Basic Safety with regard to Electromagnetic Disturbances is applicable
to all ME EQUIPMENT.
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The EU and Canada have not yet recognized this new edition.
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