Regulatory Open Forum

Hi all,

I need to determine Operating temp. of new device. Is there a standard or guidance that I can refer to that will help. Looking at 60601-1 and found Max temp during normal use but no range.

Thank you in advance.

Hi all,

I need to determine Operating temp. of new device. Is there a standard or guidance that I can refer to that will help. Looking at 60601-1 and found Max temp during normal use but no range.

Thank you in advance.

Operating temperatures are determined either by standards (60601-1-11 for home healthcare equipment has a specific range) or by assessment of the parts and materials used to build the device. Additionally you need to keep in mind compliance with the maximum temperatures listed in 60601-1 which you already located. This is because the maximum temperature you rate your equipment for will be used along with the temperature rise of the device for assessment against those limits. The higher your maximum rated ambient, the closer you are to the limits before even energizing your equipment. I can provide additional information if needed.

Hi all,

I need to determine Operating temp. of new device. Is there a standard or guidance that I can refer to that will help. Looking at 60601-1 and found Max temp during normal use but no range.

Thank you in advance.

Wade,

thank you. Any additional information would be greatly appreciated.

Operating temperatures are determined either by standards (60601-1-11 for home healthcare equipment has a specific range) or by assessment of the parts and materials used to build the device. Additionally you need to keep in mind compliance with the maximum temperatures listed in 60601-1 which you already located. This is because the maximum temperature you rate your equipment for will be used along with the temperature rise of the device for assessment against those limits. The higher your maximum rated ambient, the closer you are to the limits before even energizing your equipment. I can provide additional information if needed.

Hi all,

I need to determine Operating temp. of new device. Is there a standard or guidance that I can refer to that will help. Looking at 60601-1 and found Max temp during normal use but no range.

Thank you in advance.

IEC 60721-3 might be interesting if you're considering ambient conditions in hospitals, homes, ambulances, tents, or in shipping and storage.

Wade,

thank you. Any additional information would be greatly appreciated.

Operating temperatures are determined either by standards (60601-1-11 for home healthcare equipment has a specific range) or by assessment of the parts and materials used to build the device. Additionally you need to keep in mind compliance with the maximum temperatures listed in 60601-1 which you already located. This is because the maximum temperature you rate your equipment for will be used along with the temperature rise of the device for assessment against those limits. The higher your maximum rated ambient, the closer you are to the limits before even energizing your equipment. I can provide additional information if needed.

Hi all,

I need to determine Operating temp. of new device. Is there a standard or guidance that I can refer to that will help. Looking at 60601-1 and found Max temp during normal use but no range.

Thank you in advance.

Hi all,

I need to determine Operating temp. of new device. Is there a standard or guidance that I can refer to that will help. Looking at 60601-1 and found Max temp during normal use but no range.

Thank you in advance.

Hi Anon,

aside from the helpful comments of Anne and Wade: Could you maybe clarify what you mean by "determine operating temp"?

For example: Is this for the design input phase of a new device where you would like input what limits you should aim for? Or do you have an existing device with respective specification and would like to determine whether the acutal operating temperature matches the specification?

Best regards, Christoph

Hi all,

I need to determine Operating temp. of new device. Is there a standard or guidance that I can refer to that will help. Looking at 60601-1 and found Max temp during normal use but no range.

Thank you in advance.

Hi Anon,

aside from the helpful comments of Anne and Wade: Could you maybe clarify what you mean by "determine operating temp"?

For example: Is this for the design input phase of a new device where you would like input what limits you should aim for? Or do you have an existing device with respective specification and would like to determine whether the acutal operating temperature matches the specification?

Best regards, Christoph

Hi all,

I need to determine Operating temp. of new device. Is there a standard or guidance that I can refer to that will help. Looking at 60601-1 and found Max temp during normal use but no range.

Thank you in advance.