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Regulations for oxygen/air-tubing and connectors inside of ME equipment

M

milagre

#1
Hello everyone,

I am working on a CPAP device, and I am trying to determine what standards govern the selection of tubing and connectors that are used inside the ME equipment as inaccessible parts.


There is a standard for "Respiratory therapy equipment - Part 2: Tubing and connectors (13544-2:2002)," however, I don't think this applies to the tubing/connectors internal to the device. My opinion there is based on the standard's scope, wherein it says:

(1) The standard is for "the interface to the equipment i.e. nipples and screw threaded connectors." The inner tubing/connectors would not be considered an interface with the equipment - they are PART of the equipment.

(2) The interface specifications are given to ensure interchangeability of respiratory equipment (not a desirable feature for tubing/connectors that are inside the device and shouldn't be changed).


There are a few standards that talk about oxygen-safety related to the tubing/connectors inside the device (60601-1 and 15001:2011), and I can take those things into account. However, I am still looking for something similar to 13544-2:2002 that applies to tubing/connectors inside the device. Among other things, I want to determine if connectors like these are acceptable in a medical device (google "push in fitting quick connector", as I cannot post links yet).

Does anyone know of a standard I should be consulting here? Or maybe you think my interpretation of the scope of 13544-2:2002 is not correct?
 
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M

milagre

#2
Found another standard

I just found another standard that may apply here, though I don't have access to it right now. It is ISO 80369-1:2009 - Small-bore connectors for liquids and gases in healthcare applications -- Part 1: General requirements.

However, this standard again seems focused on ensuring the connector is non-compatible with other common medical tubes/connectors. That is not what I am looking for really, since the tubes/connectors at issue for me are ones only put together by the manufacturers (us).
 
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