DSH 411 General requirements

小米

广东安规检测
有限公司提供：

小型摆管淋雨试验机

IPX5X6X7喷水试验机

1000L恒温恒湿箱

各种试验指现货

可程式恒温恒湿试验箱

水平垂直燃烧机

自动卷线器试验机

耐划痕试验机

各种灯头量规现货

灼热丝试验机现货

GB1002插头量规

IPX1-X7淋雨现货

IEC61347/UL935镇流器热试验箱

灯具防风罩

IK冲击试验机

UL498插头插座量规

VDE0620插头插座量规

稳定性试验台

家电温升测试角

针焰试验机现货

热电偶焊机现货

家电125mm试验指

E12灯头量规

无绳壶无绳电熨斗插拔寿命试验机

IEC60335试验指甲

DSH 411 # I7 d' E! d5 O$ D

General requirements

20.1 # G& T5 h5 H" n" w; ]

60601-1(ed.2);am1;am2

* Z  }( s3 r* F  h# v# k, L/ \Standard(s)- (year and edition):
5 \; E& S: ~+ qIEC 60601-1:1988 Ed.2 Am1+Am2
Sub clause(s): 20.1
! B4 a- p  P- i7 G2 F9 YSheet n°: DSH-411
& v) T* l" l9 a0 ISubject: General requirements
" D3 h: {2 L" D% k! BKey words: Leakage current, SIP/SOP, working voltage, A-k
Confirmed by CTL at its 39th meeting, in Cologne
$ A5 L: c. Y. }' G& IQuestion:
I) Does exemption a) refer to voltages arising within the EQUIPMENT, to voltages appearing
from external sources, or both?
ii) Does exemption b) refer to the SFC of mains voltage on the SIP or SOP? Is insulation which
ensures absence of excessive LEAKAGE CURRENTS not to be tested?
3 u  Y+ i0 k; |$ w! u- C7 Niii) For exemption d) to apply, does the manufacturer have to restrict connection of the SIP and
: [# ]$ q' j# M. K, h9 ESOP to other MEDICAL ELECTRICAL EQUIPMENT or can connection to non-medical
2 r3 n/ D! l1 z4 s, l: B; n7 Uequipment be permitted, subject to some restrictions?
5 a+ d1 L: b  W% H) b0 x- mDecision:
i) a) applies only if the voltages within the SIP and SOP are less than SELV when connected to
7 H0 ^3 s* Q7 _$ eEQUIPMENT consistent with the instructions for use.
7 ^* A2 x! d$ r6 x( G7 B8 ]( N) _ii) b) applies to a SFC resulting from a single component failure within the SIP or SOP in
' Y! ^1 n0 T  ]8 [# ONORMAL USE i.e. connected as specified in the instructions for use. If such a SFC does not
# V* I+ \( F0 _$ pproduce excessive LEAKAGE CURRENTS then no additional insulation test is needed.
iii) d) applies only if the manufacturer restricts connection of the SIP or SOP to MEDICAL
' r2 p2 `; G& M8 iELECTRICAL EQUIPMENT