"to be treated as APPLIED PART": is shopping in requirements allowed?


Involved In Discussions
Hi All,

Risk management may conclude that an ACCESSIBLE PART may need to be treated as APPLIED PART, but does this mean that all requirements regarding applied parts need to be fulfilled, or only some requirements that risk management indicates?

Example: a housing may be worn on top of clothing but may have a metal accessible part, then touching may have very little risk regarding surface temperature but a leakage current may impose a high risk.
If shopping is not allowed and our overcautious QaRa manager concludes that all our accessible parts need to be treated as applied part we get into very strange reasonings regarding separation of parts.


Peter Selvey

Super Moderator
I think it is not a case applicable or not, but whether to apply a simple vs complex view. Simple view ignores the clothing, complex includes the clothing. But if there is a source of harm (heat, electrical etc.) then the issue does not disappear just because there is no direct contact. When there is a source of harm, we usually rely on a barrier prevent actual harm, and we need to know what the barrier is so we can assess the quality, reliability, need for tests and the like.

Sometimes this barrier is so big that we can really say it is not applicable. But not always.

So, we start with a simple approach and ignore the clothing and test direct to the medical device. Say this turns out OK for leakage current, but not OK for biocompatibility or temperature. In the case of biocompatibility, we could say clothing is a suitable barrier, it is kind of obvious. But temperature, it is not so clear. We think the skin temperature will be lower than medical device temperature, but how much depends type of clothing and other factors outside of the manufacturer's control.

In fact, the most likely result is that the clothing is not really a good barrier against temperature. Instead the real story could be that the temperature limits in IEC 60601-1 are not reasonable. This happens a lot. Instead of challenging the limits, the manufacturer says "it doesn't contact the patient therefore it is N/A". This is a fudge, but if there is really no safety issue, it's OK in my opinion, but there is a risk a test lab does not agree.


Involved In Discussions
Yes, part treated as AP will need to fulfill all requirements regarding applied parts, except for application of AP marking.
Top Bottom