[Problem] The present invention addresses the following problems. To produce a
urine storage bag that, while retaining the sealed structure of a sealed
urine storage bag circuit that is a
urine collection kit currently in common use, does not require any mechanical or
electrical drive or control mechanism, and that has a
structure and function, when used as a constituent element in the kit, to serve as a continuous outflow
system through the operation of the
siphon principle because of the
mass and
potential energy of urine, pressure and
abdominal pressure due to the natural filling and contraction of the
urinary bladder, and the
structure and function of the bag. To form a
urine collection kit by combining members other than the bag with conventional constituent components. To develop a closed
siphon-creating bag that, even if there is a first
height difference in which the bag is higher than an outflow source or a second
height difference in which an inflow tube is lower than an inflow port of the bag, serves as a closed
siphon-creating continuous outflow bag circuit in which there is continuous outflow to the urine storage bag. [Solution] A
quality management system was constructed by taking as a basis a suction-type closed siphon-creating bag that relies on reduction in initial siphon pressure due to negative pressure resulting from the siphon principle and a shape memory function that is exhibited because of closed format due to the material and shape of the bag, and also due to additional negative pressure. In the
system, a conventional
urine collection kit is made to function as a continuous outflow system circuit, and a series of procedures and mechanisms are included for
quality management of the
urine collection kit as a continuous outflow system circuit. Standards were planned and quality was tested in advance to devise a stable and safe continuous outflow system circuit, a closed siphon-creating bag of an engine portion thereof, and a
quality management system therefor.