Finding parts to meet ISO 15001 (Anaesthetic and respiratory equipment)

[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)

 

[milagre]

Hopeful bump.

 

[Marcelo]

I think you are referring to the EN ISO 2011 version (which is harmonized with the EU directives), as there?s no ISO version from 2011 (the ISO one is from 2010).

Anyway, regarding your questions:

- Do we really need to meet the <500mg/m2 hydrocarbon requirement in our device?

If you don?t know, I think it?s difficult for anyone to know that. My question would be, what is the requirement here? If I remember correctly, this standard was created to be harmonized with Essential Requirement 7.3. of the EU MDD

The devices must be designed and manufactured in such a way that they can be used safely with the materials, substances and gases with which they enter into contact during their normal use or during routine procedures

As any harmonized standard, it?s voluntary, and you might show compliance with the ER in other justifiable ways.

From you question, it seems you do not have another way, so it would be appropriate to following the requirements of the standard.

- Are there any acceptable in-house cleaning/validation methods to show compliance with that requirement? (since it seems no suppliers will meet it)

From what I remember when I participated more actively in the development of standards for ventilators and anesthesia, this standards was developed with a focus on the manufacturer, not supplier, because the standard deals with compatibility with oxygen in the medical device as a whole, not parts of it.

Annex A and B gives options of suitable cleaning and related cleaning validation procedures. The expectation is that you, as the manufacturer, use those as a basis for showing compliance with the standard.

 

[milagre]

Indeed, I did mean to say 2010.

Regarding your last point, my company buys the fittings for use in our device. We don't manufacture the fittings ourselves. We have been looking for a manufacturer that supplies cleaned fittings for oxygen use, but none of the companies making small-diameter fittings offer that option (even if we offer to pay for them to do the cleaning).

Thus, I am trying to figure out how to ensure the fittings are sufficiently clean in-house. This could either be through a cleaning process or inspection. I am considering the methods in Annexes A and B. The limit for hydrocarbon contamination is pretty low for our device since it is relatively low pressure. I would say we could follow the visual inspection protocol recommended in Annex B, but we can’t see ~50% of the walls inside the small diameter fittings.

I think your mention of satisfying the essential requirement without the standard is interesting. I think if we test our fittings at the max pressure/temperature they could be subjected to in a single fault condition, and if they don’t catch fire, this will demonstrate they are safe. This test, along with paperwork regarding leachables and the visual inspection (slightly limited by the geometry of the fittings) might be enough to satisfy the essential requirement.

However, I am not sure if that kind of plan would be acceptable for regulators, so I am wary of recommending it to my company.

 

[milagre]

I just reviewed Annex 5 of ISO 15001, which provides rationale for the standard's clauses. Here, there is rationale for clause 4.1, which is the clause that requires components exposed to oxygen at pressures of 50kPa-3000kPa to have a <550mg/m2 hydrocarbon contamination level.

The rationale says that:

Within the pressure range of 50 kPa to 3000 kPa, the presence of particles is not believed to be an ignition hazard, but other problems such as leaks past seals may require control of particle contamination.

I think that based on this rationale, our device does not need to comply with section 4.1. That is because our device is compliant with the section in 60601-1 that covers oxygen rich environments (11.2.2). Being compliant with this, "leaks past seals" would not cause either a dangerous situation or a loss of device function, as oxygen leaking past a seal could not cause an ignition hazard in our 11.2.2 compliant design.

Do you agree with this interpretation? How do I move forward with this issue? I assume I just document my rationale in the RMF and do NOT declare compliant with ISO 15001.

 

[Marcelo]

Well, if your only focus is on the fire/exposure hazard, you may use this rationale. However, the essential requirement for this is ER 9.3.

I "think" you still need to comply with 7.3., and I don?t think this rationale fits that ER.

 

[milagre]

Could you explain why you think that? Why do you think section 4.1(a) is related to 7.3 in some way other than fire/exposure hazards?

 

[Marcelo]

Could you explain why you think that? Why do you think section 4.1(a) is related to 7.3 in some way other than fire/exposure hazards?

I?m not saying 4.1 a) is related 7.3 in some way other than fire/exposure hazards.

I?m saying that ISO 15001 is related to more than fire/exposure hazard.

As mentioned in the introduction:

Aspects of compatibility that are addressed by this International Standard include cleanliness, resistance to ignition and the toxicity of products of combustion and/or decomposition at the design, manufacturing, maintenance and disposal stages.

If you look at the Annex ZA from the EN standard (which links the standard requirements with the essential principles it covers), you will see that the standard is meant to cover ERs 7.1 first indent, 7.3, 9.2 first indent and 9,3 (see attached image).

 

[milagre]

Ah okay. I misunderstood the previous post.

I agree that we need to make sure all of the essential requirements related to the standard are met. My plan was to document rationale for not complying with section 4.1(a), and then take guidance from the rest of the clauses in ISO 15001 to ensure all of the related essential requirements are met.

For our device, the remaining requirements are only relating to the toxicity issues in 7.1 and 7.3, which can be addressed in the biological evaluation of the device. The other aspects of 7.1,7.3, 9.2, and 9.3 mentioned in ISO 15001 would not need to be addressed, as they are either not applicable or adequately addressed by 60601-1, 11.2.2.