Is impact test according to IEC 60601-1 applicable for HAND-HELD equipment if also classified as BODY-WORN?

GOF10000

Registered
Hello,

We have product that is classified as both HAND-HELD and BODY-WORN. In 60601-1; 15.3.3, it is stated that the impact test is not applicable for HAND-HELD ME EQUIPMENT. Does anyone know the reason behind this test not being applicable for hand-held?

"Except for HAND-HELD ME EQUIPMENT and ME EQUIPMENT parts that are HAND-HELD, ENCLOSURES
and other external insulating parts, the deterioration of which could result in unacceptable
RISK, are tested as indicated below."

Depending on the reason why, I think this test maybe should be considered as N/A for a product that is classified as both HAND-HELD and BODY-WORN. What do you think?

Thanks.
 

Benjamin Weber

Trusted Information Resource
For equipment that is classified both hand-held and body-worn, I would still think the impact test is applicable.

You have to think about the reason, why the impact test is applicable for body-worn equipment, see Annex A regarding subclause 15.3.3: The test simulated an accidental impact by another person passing by or a broomstick or similar. So if your device is body-worn, this can happen and the test is applicable. Just because it as also hand-held, doesn't make this test N/A.
 
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