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flyingfrisbee
Dear cove experts,
I am in the process of trying to ensure that our new CPAP prototype is certifiably biocompatible for CE marking, but I am having trouble figuring out what needs to be biocompatible and what testing needs to be done.
The biggest question I have is based on the contact of the device. We have air streaming from the walled oxygen and the compressors through the internal tubing, filters, and etc inside the device to the external humidifier then to the tubing, then to the patient interface. From ISO 10992-1, I classified the patient interface (which is not currently involved in our CE marking process, we may recommend buying a CE marked one already) as having prolonged contact with the mucosal membranes.
The air, oxygen, or a combination of the two pass a long way before they enter the patient's lungs. Would everything need to be biocompatability tested from the air compressor to the filters to the external tubing or would just the external parts of the device (tubing and humidifier) that are disinfected regularly need to be certified biocompatable. Also, would the same cytotoxicity, sensitization, and irritation or intracutaneous reactivity testing be required for each component (filter, regulator, tubing, humidifier, etc.)?
Also, why is ISO 10993-10 "Tests for irritation and delayed-type hypersensitivity" not on the on the harmonized standards list?
Thanks in advance,
Friz
I am in the process of trying to ensure that our new CPAP prototype is certifiably biocompatible for CE marking, but I am having trouble figuring out what needs to be biocompatible and what testing needs to be done.
The biggest question I have is based on the contact of the device. We have air streaming from the walled oxygen and the compressors through the internal tubing, filters, and etc inside the device to the external humidifier then to the tubing, then to the patient interface. From ISO 10992-1, I classified the patient interface (which is not currently involved in our CE marking process, we may recommend buying a CE marked one already) as having prolonged contact with the mucosal membranes.
The air, oxygen, or a combination of the two pass a long way before they enter the patient's lungs. Would everything need to be biocompatability tested from the air compressor to the filters to the external tubing or would just the external parts of the device (tubing and humidifier) that are disinfected regularly need to be certified biocompatable. Also, would the same cytotoxicity, sensitization, and irritation or intracutaneous reactivity testing be required for each component (filter, regulator, tubing, humidifier, etc.)?
Also, why is ISO 10993-10 "Tests for irritation and delayed-type hypersensitivity" not on the on the harmonized standards list?
Thanks in advance,
Friz