ISO 10524-3-2019 pdf free.Pressure regulators for use with medical gases一Part 3: Pressure regulators integrated with cylinder valves (VIPRs). VIPRs shall, when transported, stored, installed, operated in normal use and maintained according to the instructions of the manufacturer, present no risks with an unacceptable level, under normal condition or SINGLE FAULT CONDITION, identified using risk management procedures in accordance with Iso 14971. The risks associated with the ignition of metallic and non-metallic materials, including the potential release of toxic products in an oxygen-enriched environment, shall be assessed according to the principles defined in ISO 15001. The design of the VIPR should be such that in the event of internal ignition, the consequences of the ignition are contained and the gas vented safely by the VIPR. Check compliance by inspection of the risk management file. A situation in which a fault is not detected is considered a normal condition. Fault conditions/hazardous situations can remain undetected over a period of time and as a consequence can lead to an unacceptable risk. In that case, a fault condition subsequently detected needs to be considered as a SINGLE FAULT CONDITION. Specific risk control measures to deal with such situations need to be determined within the…