CTL决议：(不知道翻的准确不）
“如果失效的绝缘隔离电路等有可能导致安全上的危险，这种绝缘应该短路，然后再确定此部分是否带电。这种短路不应视为单一故障模式，除非绝缘是符合有关要求的基本或加强绝缘”
上面是什么意思呢
欢迎大家继续发表意见。
8.4 Limitation of voltage, current or energy
8.4.2 ACCESSIBLE PARTS including APPLIED PARTS
..........................
b) * The LEAKAGE CURRENTS from, to or between ACCESSIBLE PARTS other than PATIENT
CONNECTIONS shall not exceed the limits for TOUCH CURRENT specified in 8.7.3 c) when
measured as specified in 8.7.4.
c) * The limits specified in b) above do not apply to the following parts if the probability of a
connection to a PATIENT, either directly or through the body of the OPERATOR, through which
a current exceeding the allowable TOUCH CURRENT could flow, is negligible in NORMAL USE,
and the instructions for use instruct the OPERATOR not to touch the relevant part and the
PATIENT simultaneously:
– accessible contacts of connectors;
– contacts of fuseholders that are accessible during replacement of the fuse;
– contacts of lampholders that are accessible after removal of the lamp;
– parts inside an ACCESS COVER that can be opened without the use of a TOOL, or where
a TOOL is needed but the instructions for use instruct any OPERATOR other than SERVICE
PERSONNEL to open the relevant ACCESS COVER.
EXAMPLE 1 Illuminated push-buttons
EXAMPLE 2 Indicator lamps
EXAMPLE 3 Recorder pens
EXAMPLE 4 Parts of plug-in modules
EXAMPLE 5 Batteries
For such parts, the voltage to earth or to other ACCESSIBLE PARTS shall not exceed
42,4 V peak a.c. or 60 V d.c. in NORMAL CONDITION or in SINGLE FAULT CONDITION. The d.c.
limit of 60 V applies to d.c. with not more than 10 % peak-to-peak ripple. If the ripple
exceeds that amount, the 42,4 V peak limit applies. The energy shall not exceed 240 VA
for longer than 60 s or the stored energy available shall not exceed 20 J at a potential up
to 2 V.
NOTE If voltages higher than the limits specified in 8.4.2 c) are present, the LEAKAGE CURRENT limits referred
to in 8.4.2 b) apply.
Compliance is checked by inspection of the RISK MANAGEMENT FILE, by reference to the
instructions for use and by measurement.
我觉得新版本的IEC 60601-1:2006写的最明白了，只要在说明书中说明操作者在接触电池的时候不同时接触患者，电池部位的接触电流的限制是可以豁免的。当然风险分析还是要做一下的。
关于这个论题，大家积极讨论呀。我对这个问题的观点很明确了：电池盒盖不需要加螺丝。
引用第25楼cgsh882于2008-11-10 15:47发表的:
我觉的这个问题其实延续到了应用部分与带电部分的隔离和应用部分与带电部分的耐压问题，大家的讨论我理解为这样：电池盖作为外壳16e)已经豁免，但是考虑到漏电流和耐压加上螺丝会容易通过。CTL决议我没有看懂，这个问题已经困惑了我好久了，大多数F型设备都存在这个问题，请大侠们继续指引，尤其TUV机构的大侠。
手头上有一份TUV的报告－－内部电源类的血压计，样机的电池盖也没有加电池，是从16e)进行豁免的
引用第25楼cgsh882于2008-11-10 15:47发表的:
我觉的这个问题其实延续到了应用部分与带电部分的隔离和应用部分与带电部分的耐压问题，大家的讨论我理解为这样：电池盖作为外壳16e)已经豁免，但是考虑到漏电流和耐压加上螺丝会容易通过。CTL决议我没有看懂，这个问题已经困惑了我好久了，大多数F型设备都存在这个问题，请大侠们继续指引，尤其TUV机构的大侠。
icon朋友说的很有道理，对于F型应用部分内部电源，操作者自己使用（如保健类的低频理疗器）
而且，我测试过市面上很多低频类理疗器，电池弹簧和应用部分存在导电连接。耐压肯定不能通过，不知道像低频类的有应用部分的，且与带电部件有导电连接的产品，还能不能根据16e豁免
大家讨论得很激烈，高手云集阿
