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摘录一段文字,iec60601-1-11 definition 3.1的解释:
! L- Z1 O, {1 q2 k( Z( PDefinition 3.1 – BODY-WORN
4 ~" f( y% k* t! `BODY-WORN is intended to describe ME EQUIPMENT that is wholly worn by the PATIENT. It is not" W" H; z$ u' s* Q* H8 R
intended to describe ME EQUIPMENT that is not worn by the PATIENT but has an APPLIED PART& q6 q% A. l2 |& p) O) v
which might be worn, for example a MOBILE monitor with PATIENT leads or a non-TRANSIT OPERABLE, but PORTABLE oxygen concentrator with a nasal canula or mask are not
0 y/ ?; s- Q+ u. C' L7 L7 Mconsidered to be BODY-WORN ME EQUIPMENT. |
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