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What is the safe Temperature Limit for Medical Device with blood contact ?



We are working on a product that will be in use in the vascular system and it may heat for a short period of time. My concern is that I can't find a reference for a safe temperature limit of the equipment from IEC EN 60601.

The only informations I could find were : Temperature limit of applied parts not intended to supply heat to a patient has been increased from 41?C to 43?C for surface temperatures having contact with the patient for greater than or equal to 10 minutes.


The limits in IEC 60601-1 are for external use only, they should not be used for internal applications.

IEC 60601-2-37 (ultrasounds) could be a good reference, since it covers internal as well as external. In principle, ideally a limit of 41C should be applied, which there is no known concern. The region of 41-43C is probably OK especially for short term, but there is no solid data. Above 43C cell damage is probably occurring but the body probably has some capacity to handle (any invasive procedure will cause some cell damage ...), so it could be justified for the procedure (location, purpose, benefits etc).

Assuming the body is 37C, this means a dT of +4C is no concern at all, +6C is acceptable but keep watch, and above +6C needs clinical justification.


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I don't know if it's directly applicable in your case but ASTM F2172-02 is the standard for blood/fluid warmers and it talks about limits at which hemolysis occurs. You may be able to at least use the data.


Thank you very much for the help ! I have some data concerning temperature limits and hemolysis from literature. Looking for flood / fluid warmers standard make sense, I will start with this.


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