Temperature indication In Vitro Medical Devices USA

[Paul22]

Dear all,

I can't find at the FDA website wether a temperature indication (for storage) of In Vitro Medical devices should be either in degrees ceelcius (°C) or degrees Fahrenheit (°F) or perhaps even both.
Does somebody knows? Thanks.
Paul

[Al Rosen]

Originally Posted by Paul22

Dear all,

I can't find at the FDA website wether a temperature indication (for storage) of In Vitro Medical devices should be either in degrees ceelcius (°C) or degrees Fahrenheit (°F) or perhaps even both.
Does somebody knows? Thanks.
Paul

I don't know that the FDA specifies this, but degrees farenheit is the most common temperature scale used in the USA. I have noticed that some FDA documents specify temperature in degrees C with the degrees F value in parentheses, for example, Review Criteria Assessment of Portable Blood Glucose Monitoring In Vitro Diagnostic Devices Using Glucose Oxidase, Dehydrogenase or Hexokinase Methodology states,

1. Extended exposure to air and light may alter results. It is recommended that the strips be stored in the original capped vial at temperatures below 30 ° C (86 ° F). Avoid exposure to excessive humidity; do not freeze.

I have seen device labeling with only degrees C. I have used degrees F with degrees C in parentheses. I don't think you will have problem with any way you do it, as long as it is clear which temperature scale you are using.

[Paul22]

Thanks Al,
I will consider your proposal. In my opinion it seems also the best to use both temperature units.
Have a Merry Christmas and a Happy 2006
Paul

Originally Posted by Al Rosen

I don't know that the FDA specifies this, but degrees farenheit is the most common temperature scale used in the USA. I have noticed that some FDA documents specify temperature in degrees C with the degrees F value in parentheses, for example, Review Criteria Assessment of Portable Blood Glucose Monitoring In Vitro Diagnostic Devices Using Glucose Oxidase, Dehydrogenase or Hexokinase Methodology states, I have seen device labeling with only degrees C. I have used degrees F with degrees C in parentheses. I don't think you will have problem with any way you do it, as long as it is clear which temperature scale you are using.