Classifications

• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
  • G01N19/00—Investigating materials by mechanical methods
  • G01N19/04—Measuring adhesive force between materials, e.g. of sealing tape, of coating

Definitions

• the invention relates to a device for testing sealed seams on sterilization packaging, and, in particular, a device for testing the sealed seams of bag-like packaging used for sterilizing hospital instruments, as well as for testing the condition of the sealers.
• the underpressure-overpressure-underpressure cycle is consecutively repeated a few times and causes the pressure inside the packaging to vary accordingly, in proportion to the surroundings.
• the bag expands and shrinks in turn.
• the seams of the packaging must therefore be able to withstand great strain during sterilization.
• hospital instruments or instrument sets gathered for an operation can be very heavy and seams are therefore subjected to great amounts of strain.
• the endurance of the bag's sealed seam would have to be assured earlier, in the phase when the packaging was being carried out and the sealed seam was being made.
• Requirements for the sealed seams of sterilization packaging are presented, for example, in sterilization packaging standards EN 686 or DIN 58953.
• the three sides of the sterilization packaging, which are sealed at the factory, are tested by the manufacturer in a way, which is required in the manufacture of the products in question.
• the manufacturer of the packaging is naturally the best expert, and sealing or the control of the sealing normally doesn't present problems for them.
• the manufacturer uses certain machinery, certain raw materials and certain parameters for manufacture, and knows the right combination to ensure good products which comply with requirements.
• the manufacturer's responsibility ends when a health care facility begins to use the products. The user must then be prepared to test the properties of the last seam to be made, since the user is the one to make it.
• the object of the invention is to provide a testing device, whereby the preceding presented disadvantages associated with current devices will be eliminated.
• the object of the invention is to provide a testing device, by which a quick and reliable seam test can be obtained, by which the strength of the seam can be judged and, at the same time, by which the condition of the heat sealer used for sealing can be determined for the moment that the seal was made.
• a further object of the invention is to provide a testing device, which is advantageous to produce and obtain.
• a testing device formed in accordance with the invention comprises a frame, which is joined onto a base, a unit of mass located on the frame and which is movable on a vertical plane, a means of fastening located on the frame and/or unit of mass for fastening the sample, and a conveying device for moving the sample and/or unit of mass in relation to one another.
• the sealed seam can be tested by fastening the sample to the means of fastening and using the unit of mass to put strain on the sample.
• the sample can be tested by lowering the unit of mass downwards after fastening the sample and then releasing it back up towards the sample.
• the sample can be tested by moving it upwards after it has been fastened, and by releasing the unit of mass from its position.
• a unit of mass of the appropriate weight is selected, such that, if the test sample withstands the strain from the unit of mass, the seam is in accordance with requirements.
• the testing device comprises a conveying device to move the sample in relation to the unit of mass. In this case, the sample is moved upwards by the conveying device until the unit of mass is supported by the sample. Thus, reliable test results are obtained.
• the testing device comprises a conveying device to move the unit of mass in relation to the sample.
• the unit of mass is moved downwards by the conveying device until the unit of mass is supported by the sample.
• the present invention comprises one or more separate supplemental units of mass, which are fastened to the main unit of mass in a way known as such, and, for example, with a magnetic fastener.
• Figure 1 illustrates a side and cross-sectional view of a sterilization packaging
• Figure 2 illustrates a side view of a testing device formed in accordance with the invention
• Figure 3 illustrates a frontal view of a testing device formed according to Figure 2
• Figure 4 illustrates an enlarged detail X from Figure 2.
• Figure 1 illustrates a certain sterilization packaging 15. In manufacturing it, the sides of the bag are joined together with a factory-made seam 16. The manually sealed seam 17 is at the other end of the packaging.
• the figure illustrates a test sample 14 taken from the factory-made seam and an illustration of the test being done on it, performed by its being pulled in opposite directions.
• the width of the sample clipping should be 15 mm.
• the sample is fastened to the device with a special means of fastening, which is, in most cases, a compressed air clip.
• the sealed materials are pulled apart from one another.
• the previously mentioned measuring device adapted for the purpose, registers the force used to pull apart the materials.
• a testing device according to Figures 2-4 is comprised of a frame 2, which is fastened to the base 1.
• the so-called conveying device which, in this application, comprises a nut piece 3, with closely set inside threads, a conveyor screw 4 and guide bushing 5 for the conveyor screw, is fastened to the frame.
• the testing device comprises a unit of mass 6 of a selected weight, which moves on a vertical plane, and its movement controls 7.
• the movable support 8 On the lower end of the conveyor screw 4, which is screwed inside the nut piece 3 and placed inside the guide bushing 5, is the movable support 8 for the unit of mass, and on the upper end is a spindle 9.
• On the side of the unit of mass there is another screw guide bushing 10 and holes 11 for the vertical movement controls 7 of the unit of mass.
• the controls are bar- like pieces.
• the unit of mass and frame comprise a means of fastening 12 for the test sample 14.
• the means of fastening is a screwing clip, but other means of fastening can be used in other applications.
• the strength of the seam can be compared to some other absolute strength value by fastening supplemental units of mass 13 to the unit of mass. They can be fastened in a way known as such, and, for example, using a magnetic fastener.
• test sample 14 When using a testing device formed in accordance with Figures 2-4, the test sample 14 is placed in the means of fastening 12 while the unit of mass is in the upper position.
• the conveyor screw 4 is turned, whereupon the unit of mass 6, sitting on the support 8, is lowered downwards until it finally is supported by the test sample.
• the weight of the unit of mass is selected, such that, if the test sample withstands the strain caused by the unit of mass, the seam will be in compliance with requirements.
• the unit of mass is connected to and supported on the frame of the testing device, such that the unit of mass can move freely in a vertical direction.
• the conveying elements of the conveying device are fastened to the sample and the sample is fastened to the unit of mass by the means of fastening.
• the weight of the unit of mass affects the seam and when moving the sample upwards, the unit of mass can move upwards to the sample, whereupon all of the weight of the unit of mass is supported by the sample.
• the weight of the unit of mass is chosen, such that, if the test sample withstands the strain caused by the unit of mass, the seam will be in compliance with requirements.
• a test using the testing device formed in accordance with the present invention is carried out mainly with the same principles as are found in the previously mentioned German DIN 58953 standards, but instead of using the force of a machine to provide strain for the test, the force of gravity is used.
• the force of gravity is used.

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• Physics & Mathematics (AREA)
• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Chemical & Material Sciences (AREA)
• Analytical Chemistry (AREA)
• Biochemistry (AREA)
• General Health & Medical Sciences (AREA)
• General Physics & Mathematics (AREA)
• Immunology (AREA)
• Pathology (AREA)
• Investigating Strength Of Materials By Application Of Mechanical Stress (AREA)

Applications Claiming Priority (3)

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• 2000
  • 2000-05-16 FI FI20001168A patent/FI109834B/sv active
• 2001
  • 2001-05-16 EP EP01934058A patent/EP1290426A1/en not_active Withdrawn
  • 2001-05-16 WO PCT/FI2001/000475 patent/WO2001088503A1/en active Application Filing
  • 2001-05-16 AU AU2001260375A patent/AU2001260375A1/en not_active Abandoned

Non-Patent Citations (1)

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