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Description / Abstract:
This Standard applies to the safety of MEDICAL ELECTRICAL
EQUIPMENT (as defined in Sub-clause 2.2.15).
Although this Standard is primarily concerned with safety, it
contains some requirements regarding reliable operation where this
is connected with safety.
SAFETY HAZARDS resulting from the intended physiological
function of EQUIPMENT covered by this Standard are not
considered.
Appendices in this Standard are not mandatory unless made so by
an explicit statement in the main text.
1.1DV D2 Replacement of the third paragraph of 1.1
with the following:
SAFETY HAZARDS resulting from intended physiological
function of EQUIPMENT covered by this Standard are not considered.
These requirements do not contemplate the investigation of
protection against ionizing radiation or radioactive isotopes. Such
EQUIPMENT is subject to Federal radiation Standards (21CFR Part
1020) promulgated under the Radiation Control for Health and Safety
Act of 1968.