EBME Forums Forums Maintenance Technical Assistance Contact temperature in an incubator

Dear All,
We were trying out the INCU tester from Ultramedic and found a high temperature area on the mattress of an incubator. Just above the heater element the temp was 42.4 degrees. The air temp was 37 degrees as set so it was working correctly. This seems a very high temp to me.
The MDA could not give me a maximum temp that is allowed to be in constant contact with a patient.
The company is having to refer back to Germany for an answer. (Guess who it is)
Can you people help out?
I do not have a copy of the relavent standard I expect it is in there. ISO 60601 part 2.35 if anyone has access.
Thanks
Robert Kightley

Robert,

Correct first time, you need to buy from BSI a copy of BS EN 60601, Part 2 for Nursing Incubators. NHS are members of BSI, therefore 50% of the non member purchase price.

Jim

Jim and anyone who is inerested,
The NHS is no-longer a member of BSI as they are now only partially goverment funded. Each individual hospital or trust has to join to get the benefits of half price standards. There is a fixed cost of £158.63 inc vat for health care organisations.
It is only worth it if you are going to get several standards.
Robert
NB. Membership applies to the whole trust so see if estates want to chip in - or are already members.