Is a Non-Automatic Weighing Instrument a Medical Device?

W

w_grunfeld

#1
Is a non-automatic weighing instrument for "determination of mass in the practice of medicine for weighing patients for the purposes of monitoring,diagnosis and medical treatment" a medical device ? i.e. is IEC 60601 APPLICABLE?
I tend to think it falls under DIRECTIVE 2009/23/EC on non-automatic weighing instruments, has anyone differing opinion/knowledge?
Thanks!
 
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Ronen E

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#2
Is a non-automatic weighing instrument for "determination of mass in the practice of medicine for weighing patients for the purposes of monitoring,diagnosis and medical treatment" a medical device ? i.e. is IEC 60601 APPLICABLE?
I tend to think it falls under DIRECTIVE 2009/23/EC on non-automatic weighing instruments, has anyone differing opinion/knowledge?
Thanks!
‘medical device’ means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:
— diagnosis, prevention, monitoring, treatment or alleviation of disease,
— diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
— investigation, replacement or modification of the anatomy or of a physiological process,
— control of conception,
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;
Sounds like it is a medical device.

If other EC directives that lead to CE marking are applicable as well, then all of these must be complied with before applying the CE mark.

Cheers,
Ronen.
 
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