Determination of Clean Room Class for Medical Devices

somashekar

Staff member
Super Moderator
#1
When we look into the ISO 8536-4:2010 (Infusion equipment for medical use -- Part 4: Infusion sets for single use, gravity feed) and in this into the Annex A., which gives requirement of particulate matter and its assessment and acceptable value (N<90), how can we use this information as an input in the risk management to determine the clean room class that best suits the device.

The Annex A refers to counts of particulate matter of size 25-50 micron, 50-100 micron, and > 100 micron.

Many device types does fall into the typical single use infusion set, and any guidance on this will be most helpful.
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
When we look into the ISO 8536-4:2010 (Infusion equipment for medical use -- Part 4: Infusion sets for single use, gravity feed) and in this into the Annex A., which gives requirement of particulate matter and its assessment and acceptable value (N<90), how can we use this information as an input in the risk management to determine the clean room class that best suits the device.

The Annex A refers to counts of particulate matter of size 25-50 micron, 50-100 micron, and > 100 micron.

Many device types does fall into the typical single use infusion set, and any guidance on this will be most helpful.
Hi,

I've looked into this issue (particulate matter contamination limits for infusion disposables) long and hard in the past, with no good results.

The painful truth is that there is no consensus across the medical practitioners community with regards to particle size distribution requirements, except the obvious "the lesser the better". AFAIK standards will give you little insight in that regard. If you share the standards contents with practicing medical experts, some might tell you it's "nonsense", but at the same time they most likely won't offer a solid alternative.

In practice, this kind of devices is usually made in class 8 cleanrooms. If you have a specific, more demanding application you might want to go to class 7, but I'd recommend that only if you have solid / broad requirement base that indicates a real need.

Cheers,
Ronen.
 
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