Definition Enclosure - IEC 60601-1 definition

Hi all,

I am trying to seek clarification on the term "Enclosure" in the IEC 60601-1 standard. The definition in the standard is:"exterior surface of electrical equipment or parts thereof".

In my project we have a device that has a plastic clam shell moulding and from it a polymer tube exists. Within the clam shell there are electrical components as the clam shell acts as a "plug" for want of a better word tat fits into a third party device. At the moment I can see this clam shell to be an enclosure which brings problems my way due to the ammount of testing we need to do and also the high probabilty that the clam shell will not be able to withstand 250N worth of force.
In use the clam shell fitting will house components and plug into another device in a plug like way and there will be no force applied, is there a way I can justify this clam shell so that it is not an "enclosure"?

Any help much appreciated!

If you check the rationale (Annex 1) for definition 3.26 - Enclosure, it states that the enclosure includes all the accessible parts of the device. If your device is not accessible then it is possible that the enclosure requirements do not apply.

Note also that the various mechanical strength tests that you hint at (such as the 250N test of 15.3.2) are all very focused on risk. They do not state that 'if it breaks it fails' but rather 'must not result in unacceptable risk'. So you could have a partial breakage that, for example, does not expose dangerous voltages and which may be an acceptable risk, depending upon your risk management and criteria.

Medical electrical equipment ¨C Part 1: General requirements for basic safety and essential performance - Third Edition 790 Page(s)