ISO 10524-1:2018 pdf free
ISO 10524-1:2018 pdf free.Pressure regulators for use with medical gases
PRESSURE REGULATORS 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 PRESSURE REGULATOR should be such that in the event of internal ignition, the consequences of the ignition are contained and the gas vented safely.
Check compliance by inspection of the risk management file.
NOTE A situation in whicha 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 risk management process.
PRESSURE REGULATORS and components, or parts thereof, using materials or having forms of construction different from those detailed in this document, shall be presumed to be in compliance with the safety objectives of this document if it can be demonstrated that at least an equivalent degree of safety is obtained (i.e. compliance with requirements presumes that risks have been mitigated to acceptable levels) unless objective evidence to the contrary becomes available.
Objective evidence may be obtained by post-market surveillance.
Evidence of at least an equivalent degree of safety shall be provided by the manufacturer.
NOTE Regional or national regulations can require the provision of evidence to a competent authority or a conformity assessment body, e.g. to a notified body in the European Economic Area (EEA) upon request.ISO 10524-1 pdf free.
