ISO 10079-2-2014 pdf free download.Medical suction equipment 一 Part 2: Manually powered suction equipment.
6.1.2.2()For suction equipment intended for field use and which is intended to continue operating when the collection container is full, the volume of the collection container shall be not less than 200 ml. Check compliance by functional testing and inspection.
6.1.2.3For all other suction equipment, including suction equipment intended for transport use, the usable volume of the collection container shall be not less than 500 ml.
Check compliance by inspection and the tests given in A.2.
6.1.3 Container strength
The collection container shall not implode, crack or permanently deform and shall meet the requirements ofClausesZ and 9, as appropriate, after being subjected to a pressure of either 120% of the manufacturer’s recommended maximum vacuum level or 95 kPa below atmospheric, whichever is less, for 5 mm.
Containers intended for re-use shall be tested after 30 cycles of cleaning and disinfection or sterilization as recommended by the manufacturer.
Check compliance by the test given in A3.
6.2 Connections
6.2.1 Tubing connectors for collection containers
The connectors for the suction tubing and the intermediate tubing shall be designed to facilitate correct assembly or clearly marked to indicate correct assembly when all parts are mated.
Check compliance by functional testing and inspection.
NOTE Incorrect connections have frequently been a cause of spill over into the vacuum source and a loss of
suction.
6.2.2 Inlet port
The inside diameter of the suction tubing connector (inlet port of the collection container) shall be at least 6 mm and the inside diameter of the suction tubing connection (inlet port) shall be equal to or larger than the inside diameter of the largest tubing size as specified by the manufacturer.
The inlet shall not be compatible with any conical connector specified in ISO 5356-1 or small-bore connectors specified in ISO 80369 (all parts).
Check compliance by functional testing and inspection.
NOTE Because of the risk of misconnection, the internal diameter of the inlet port of the collection container should not be greater than 14 mm.
6.2.3 Exhaust port
It shall not be possible to connect suction tubing to the exhaust port.
Check compliance by functional testing.
6.3 Suction tubing
6.3.lSuction tubing shall have an inside diameter of not less than 6 mm.
The degree of collapse of the suction tubing shall be less than 0,5 throughout its entire length.
Check compliance by the tests given in A.4 using the tubing specified by the manufacturer of the suction equipment.ISO 10079-2 pdf download.