IEC 60601 - Essential performance c.2.34

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W3r0nika

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Hello,
C.2.34 Does the use of the medical device depend on essential performance?
I don't really know how to understand this point despite reading 60601. So we make electrosurgical units. Is this the point to write the risks of a neutral electrode? I understand that from 60601. (section 201.4.3) Please help and explain :(
 
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W3r0nika said:
Hello,
C.2.34 Does the use of the medical device depend on essential performance?
I don't really know how to understand this point despite reading 60601. So we make electrosurgical units. Is this the point to write the risks of a neutral electrode? I understand that from 60601. (section 201.4.3) Please help and explain :(
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Read this article carefully, you will get your answer. First, you will need to list the performance(s) of the device and then decide whether the device failure (by missing the intended performance level) would harm the patient or not. I don't know what kind of electrosurgical device you manufacturer, so I am unable to define any essential performance for your device. Read the article and the example provided in there for a better understanding of what would be the potential "essential performance" of your device.

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PaulGr

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From your question, it looks like you are completing the questionnaire from ISO14971:2007? Please keep in mind that this questionnaire is informative and helps you identifying characteristics and hazards that are applicable. In the new ISO14971 (2019) this section is removed and moved to the TR document. So don't bother too much about answering all questions but focus on a good description of these characteristics and related hazards. The fact that your system requires a neutral electrode with all the related risks is indeed i.m.o. a characteristic that could affect safety.
 
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