M
milagre
I am hoping to get in touch with someone who has worked with ventilators or anaesthetic gas machines before. My company is making an infant CPAP, and as such, we are trying to comply with ISO 15001:2011 - "Anaesthetic and respiratory equipment - compatibility with oxygen".
We are having a hard time finding tubing connectors that meet the requirements for this standard. I think this might be because of my interpretation of the standard.
Per section 4.1 of the standard, I determined we only need to show a level of hydrocarbon contamination less than 550mg/m2. This is because our device is in the range of 50 kPa to 3000 kPa.
I have been pursuing tubing fittings that are "degreased" for use with oxygen to try to fulfill this requirement. Unfortunately, it seems most companies that make fittings don't offer the degreased options for small fittings. Our fittings need to be in the range of 6-10mm tubing.
Failing to find officially "degreased" options, I turned to the annex of ISO 15001. Here, in Annex B, I found that one way of validating a cleaning procedure is to observe the component for absence of contaminants with normal vision udner a strong white light. This method can detect conamination down to 500mg/m2.
I am pretty sure that fittings that are bought NOT degreased meet this inspection criteria. Looking into it more, most of the "degreased" fittings out there seem to strive for <100mg/m2 hydrocarbon content, which is way less than we need. This is usually achieved through some series of heat and chemical cleaning processes.
My main questions in this situation are:
- Do we really need to meet the <500mg/m2 hydrocarbon requirement in our device?
- Are there any acceptable in-house cleaning/validation methods to show compliance with that requirement? (since it seems no suppliers will meet it)
We are having a hard time finding tubing connectors that meet the requirements for this standard. I think this might be because of my interpretation of the standard.
Per section 4.1 of the standard, I determined we only need to show a level of hydrocarbon contamination less than 550mg/m2. This is because our device is in the range of 50 kPa to 3000 kPa.
I have been pursuing tubing fittings that are "degreased" for use with oxygen to try to fulfill this requirement. Unfortunately, it seems most companies that make fittings don't offer the degreased options for small fittings. Our fittings need to be in the range of 6-10mm tubing.
Failing to find officially "degreased" options, I turned to the annex of ISO 15001. Here, in Annex B, I found that one way of validating a cleaning procedure is to observe the component for absence of contaminants with normal vision udner a strong white light. This method can detect conamination down to 500mg/m2.
I am pretty sure that fittings that are bought NOT degreased meet this inspection criteria. Looking into it more, most of the "degreased" fittings out there seem to strive for <100mg/m2 hydrocarbon content, which is way less than we need. This is usually achieved through some series of heat and chemical cleaning processes.
My main questions in this situation are:
- Do we really need to meet the <500mg/m2 hydrocarbon requirement in our device?
- Are there any acceptable in-house cleaning/validation methods to show compliance with that requirement? (since it seems no suppliers will meet it)