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I was wondering in general how rigorously standard testing must be followed for CE marking. Can we make a reasonable argument for changing the standard tests in some cases?
For example our CPAP utilizes a medical hose to source oxygen to the oxygen mixer. We are performing testing in accordance with ISO 5359. I was wondering if we have to follow the standard exactly even if it is far out of the device specs, such as clause 4.4.14 pressure of the ISO 5369. Our device doesn't have a flowrate of 200L/m. At max it might be 30 L/m for our device. Do we still need to perform a pressure drop test at 200L/m, when the device won't get anywhere near this high?
For example our CPAP utilizes a medical hose to source oxygen to the oxygen mixer. We are performing testing in accordance with ISO 5359. I was wondering if we have to follow the standard exactly even if it is far out of the device specs, such as clause 4.4.14 pressure of the ISO 5369. Our device doesn't have a flowrate of 200L/m. At max it might be 30 L/m for our device. Do we still need to perform a pressure drop test at 200L/m, when the device won't get anywhere near this high?
