F
flyingfrisbee
Dear people more knowledgeable than me about standards,
I am new to the cove, since I just started my first job and have only really started looking at standards for the past month. Please bear with my limited experience.
I am working at a small engineering company in Vietnam and I am in charge of most of the CE marking, standard reading, and testing for our new medical device.
I have the job of selecting a pressure regulator for integration into our medical device. The pressure regulator should be dropping the pressure of oxygen from 100 psi to 30 psi or less. The pressure regulator is connected to a humidifier that mixes oxygen and medical air. The humidifier is in the process of complying with IS EN ISO 8185:2009.
So, I was wondering what standards the pressure regulator needs to comply with. ISO 8185:2009 says the regulator needs to comply with ISO 10524-1, however, I believe that the description says that is is for devices for up to 25000 kPa, which sounds too high. I looked at ISO 10524-4, which is for low pressure regulators.
Also, I have been looking at 2 different regulators. One has no ISO certification, but fits better with our design. The other one is CE mark certified for pressure equipment to be fitted with gas cylinders BS EN ISO 10297:2006, see attached CE mark documentation. I was wondering if the CE marked regulator would require fewer tests than the non CE mark certified regulator.
Take care,
Friz
I am new to the cove, since I just started my first job and have only really started looking at standards for the past month. Please bear with my limited experience.
I am working at a small engineering company in Vietnam and I am in charge of most of the CE marking, standard reading, and testing for our new medical device.
I have the job of selecting a pressure regulator for integration into our medical device. The pressure regulator should be dropping the pressure of oxygen from 100 psi to 30 psi or less. The pressure regulator is connected to a humidifier that mixes oxygen and medical air. The humidifier is in the process of complying with IS EN ISO 8185:2009.
So, I was wondering what standards the pressure regulator needs to comply with. ISO 8185:2009 says the regulator needs to comply with ISO 10524-1, however, I believe that the description says that is is for devices for up to 25000 kPa, which sounds too high. I looked at ISO 10524-4, which is for low pressure regulators.
Also, I have been looking at 2 different regulators. One has no ISO certification, but fits better with our design. The other one is CE mark certified for pressure equipment to be fitted with gas cylinders BS EN ISO 10297:2006, see attached CE mark documentation. I was wondering if the CE marked regulator would require fewer tests than the non CE mark certified regulator.
Take care,
Friz
