BS EN ISO 22442-3 pdf free download.Medical devices utilizing animal tissues and their derivatives – Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents.
Cylinder valves with integrated pressure regulators are used to reduce the high cylinder pressure to a lower pressure suitable for use.
These functions cover a wide range of inlet and outlet pressures and flows which require specific design characteristics. It is important that the operating characteristics of these valves be specified and tested in a defined manner.
Such valves are more complicated than conventional cylinder valves yet subject to the same environmental and transportation conditions. These conditions should be borne in mind at the design and development stage. This International Standard pays particular attention to
—suitability of materials;
—safety (mechanical strength, safe relief of excess pressure and resistance to ignition);
—gas-specificity,
—cleanliness;
—testing;
—identification,and
—information supplied.
This International Standard applies to cylinder valves with integrated pressure regulators (VIPR) intended to be fitted to gas cylinders that convey compressed, liquefied or dissolved gases.
This International Standard is not intended for medical applications (see ISO 10524-3).Further, additional specific requirements for valves fited with safety valves and bursting discs (see EN 14513) and for valves fitted with residual pressure valves (see ISO 15996) are not covered by this International Standard.
5 Design requirements
5.1 General
VIPR shall operate satisfactorily over a range of service temperatures, from-20°C to+65°C. The range may be extended for short periods (e.g. during filling).Where higher or lower service temperatures are required for longer periods, the purchaser shall specify accordingly.
VIPR shall be capable of withstanding the mechanical stresses or chemical attack they may experience during intended service, e.g. during storage, valving into clinders, filling processes, transportation and end use of the cylinder.

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