Cleanliness/Bioburden for Non-Sterile Gas Path Medical Devices

[VirginiaA]

Does anybody know what are the requirements for acceptable cleanliness/bioburden on a medical device that is not sterile? The device in question is a breathing tube for a ventilator that does not need to be sterile. My understanding is that I need to determine the cleanliness level in the risk analysis and then create a spec but I am not sure if there are any standards or guidance for the required cleanliness level. How do I go about what level of clean/bioburden is acceptable? Your feedback is much appreciated!

 

[Ronen E]

Does anybody know what are the requirements for acceptable cleanliness/bioburden on a medical device that is not sterile? The device in question is a breathing tube for a ventilator that does not need to be sterile. My understanding is that I need to determine the cleanliness level in the risk analysis and then create a spec but I am not sure if there are any standards or guidance for the required cleanliness level. How do I go about what level of clean/bioburden is acceptable? Your feedback is much appreciated!

Hello and welcome to the Cove

This is essentially a question for your clinical advisors. Another option would be looking into ventilators-specific standards (unfortunately I can't be more specific off the top of my head).

Cheers,
Ronen.

 

[Pads38]

There is a series of standards from ISO covering requirements for breathing gas pathways. Part 1 (of 4) is here:

https://www.iso.org/standard/62892.html?browse=tc

Also - search the ISO site for all standards that come under the relevant committee. Which is ISO/TC 121/SC3:

https://www.iso.org/committee/52012/x/catalogue/

 

[SteveK]

Now that the ISO 18562 series of standards have now been published, I suppose all companies who supply the relevant products will have to start searching for test houses to comply. More expense, assuming there are such places considering these new standards were only published 31st of March this year. Obviously CD, DIS, FDIS etc. copies have been around for a while.

Steve

 

[Pads38]

Those interested in this topic may also be interested in an upcoming webinar being presented by UL, (first week of June).

Information and free registration here:

http://connect.ul.com/VOC_and_Parti...PUzM5a0pRbnNpWlE0K1wvTVwvRVlCMjRKQ1RHU1FzIn0=

(Disclosure - no connections)

 

[SteveK]

Interestingly I checked with UKAS whether anybody (at least in the UK) was accredited (ISO 17025) to conduct the tests in ISO 18562 - and nobody is!

Steve

 

[SteveK]

Further info.

I did find a place (not in the UK) who can do testing to ISO 18562-2 (particles) and 18562-3 (VOC).They supplied a quote for testing one product, that came to nineteen thousand dollars. Now if I broke all our products down to the least number of variants, I reckon the overall test bill would not leave us with much change out of quarter of a million dollars!

Steve

 

[Pads38]

I did have to do a 'particles' test some years ago. Could not find any test house with that test as part of their 'Scope'.

But the test was based upon a pharmaceutical test and I was able to find a pharma test house who, once I had provided the test details were able to conduct the test.

The NB did bring this up during Design Examination, but let it go in the end.