标题: 体温计 手持式还是 body worn [打印本页] 作者: emailsimon 时间: 2015-12-14 11:26 标题: 体温计 手持式还是 body worn 最普通的电子体温计 各位大神到底是判成手持式还是 body worn % ~7 [; q; @1 D. f为什么认证机构把我司产品判成手持式?? ; `* B! Y S8 H* h9 y3 D这合理吗?作者: Aslan 时间: 2015-12-14 16:03
手持式。这样不好么?作者: 202meng 时间: 2015-12-14 16:05
为什么认为是 body worn?5 t& z2 I7 E5 b9 N: U* R( S 作者: Aslan 时间: 2015-12-14 16:12
摘录一段文字,iec60601-1-11 definition 3.1的解释: 6 D9 x. L3 U: cDefinition 3.1 – BODY-WORN8 \' w+ W% b; y
BODY-WORN is intended to describe ME EQUIPMENT that is wholly worn by the PATIENT. It is not 7 ]+ l a/ S+ b( y5 Q$ gintended to describe ME EQUIPMENT that is not worn by the PATIENT but has an APPLIED PART % C! \) R! ~. t' r5 T+ w4 ~5 [, K) Pwhich 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( O( ^1 u' p: S8 ~5 E: D
considered to be BODY-WORN ME EQUIPMENT.作者: Aslan 时间: 2015-12-14 16:14
类似holter那种,需要随身携带,不管是贴身还是隔着衣服,才算是body-worn 设备。作者: emailsimon 时间: 2015-12-14 16:28
202meng 发表于 2015-12-14 16:05 9 B" m# ^ x, h: \( a
为什么认为是 body worn?