M
milagre
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?
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?