Compressed air quality in ME equipment (used in OR)

EMengineer

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Hi, we have ME equipment which has internal air compressor to provide pressure to cylinders. The whole device is used in operating room. Is there any air quality restrictions? The 60601-1 does not mention anything about what air should be used. Maybe there is some reference material?
 

EMengineer

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ADDITION:
I found ISO 8573-1 requirements for compressed air. Although this air would be used within equipment itself.
What I can find is requirements only for compressed air supply (hospital gas system), but no specific information about what air could be used in ME equipment which is used in operating room (does compressed air should be sterile or not). I imagine that air should be clean and so on, but not sure how clean.
 

yodon

Leader
Super Moderator
Don't really know but, with everything being "risk based," what's the risk if the gas escapes? Are there similar devices? If so, any idea what they do?
 

EMengineer

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Maybe you are right and this issue should be covered by risk assessment. My concern is about pneumatic parts, e.g. lubricated piston close to sterile part of the equipment. Unfortunately I didn't find anything similar in the market and don't have starting point.
 

AgnieszkaSz

Involved In Discussions
Just an idea - you can measure airborne particles in cleanroom when the device is idle and then perhaps after 30 minuts or 1 hour after device operates. You will see whether particle concentration increases or not.
 
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