ISO 10524-3:2019 pdf free
ISO 10524-3:2019 pdf free.Pressure regulators for use with medical gases一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 risk management process.
The PRESSURE-RELIEF DEVICE is tested to ensure that it automatically opens at the specified opening pressure in case of a fault in the VIPR resulting in high pressure. Correct operation of the PRESSURE-RELIEF DEVICe prevents high pressure from reaching the downstream medical device. The PRESSURE-RELIEF DEVICE is also tested to ensure that it closes at the specified closing pressure to minimize gas loss following pressure relief.
a) To check the leak tightness of the PRESSURE-RELIEF DEVICE, the pressure shall be increased to approximately 468 kPa (85 % of 550 kPa) or 978 kPa (85 % of 1150 kPa) for air or nitrogen for driving surgical tools. The leak tightness of the PRESSURE-RELIEF DEVICE shall comply with the requirements of 6.12.1.
b) The pressure shall then be further increased slowly at a rate not exceeding 15 kPa (0,15 bar)/s until the first bubbles are observed from the outlet of the PRESSURE-RELIEF DEVICE. The opening pressure shall be recorded.
c) Increase the pressure to 1 000 kPa or 2 000 kPa for air or nitrogen for driving surgical tools and measure the discharge capacity.
d) The pressure shall gradually be decreased at a rate not exceeding 20 kPa [0,2 bar)/s until the PRESSURE-RELIEF DEVICE reseats and the reseat pressure shall be recorded.ISO 10524-3 pdf free download.
