The gloves are stored in consumer packaging for the intended shelf life at a temperature specified by the manufacturer. Afterwards, the gloves are tested for watertightness according to EN 455-1 and for tensile strength according to EN 455-2. The integrity of the packaging and the suitability of the gloves for their intended use are also verified. The shelf life corresponds to the time at which all specified tests are still successfully passed.
According to DIN EN 455-2, the dimensions and the tensile strength of a medical disposable glove are determined. At least 13 samples per glove batch are used. For dimensional verification, the glove length and width are measured using a ruler and compared with the size table specified in the standard.
Depending on the intended use of the gloves, different dimensional requirements apply. For determination of tensile strength, dumbbell-shaped specimens are punched from the palm area of the gloves. The single wall thickness of the glove and the thickness of the dumbbell specimen are measured. The statically determined tensile force is multiplied by the ratio of single wall thickness to specimen thickness. The resulting tensile force value is then compared with the values specified in the standard.
According to DIN EN 455-1, a water leak test can be performed to verify the watertightness of disposable gloves. Using a vertical tube, 1000 ml of water at a temperature between 15 °C and 35 °C is filled into the glove to be tested. The glove is immediately visually inspected for leaks. The glove is considered non-watertight as soon as water leakage occurs. After 2 to 3 minutes, the glove is visually inspected again.
We offer a testing procedure to evaluate the fixation strength of the glenoid component in bone and its resistance to subluxation caused by cyclic movement (e.g., superior-inferior or anterior-posterior) of the humeral head against the edge of the glenoid, according to the ASTM F2028 standard. This test method can be applied to both cemented monolithic and modular glenoid components as well as uncemented reverse glenoid components.
The glenoid component is fixed in a bone substitute material using bone cement, and the humeral head component is placed into the glenoid component. An axial load is applied through the glenoid component while the humeral head is moved in opposite directions to determine the maximum displacement before dislocation. Then, the humeral head is cyclically moved at a speed of up to 50 mm/min for 100,000 cycles in both directions until 90% of the displacement at dislocation is reached. During the test, axial displacement (rocking) of the glenoid edges is recorded. The test can be conducted dry or in water at 37°C.
ASTM F1829 describes a test method to determine the static shear force required to loosen modular glenoid components (insert and backing) of shoulder replacements. The test is suitable for metal joints, polymers, or composites and is used for design validation or comparison with other replacements. Wherever possible, the test should reflect the clinical use of the implant, meaning representative specimens of the finished product are tested and sterilized as required by the manufacturer.
For testing, specimens are fixed in the testing machine parallel to the implant axis. A vertical load is first applied from inferior to superior, and the loosening rate is recorded. The test is stopped when one of the following occurs:
After this, a new insert is placed in the test fixture, and the test is repeated under the same conditions but applied from anterior to posterior. The test is stopped again as soon as one of the above cases occurs. The backing is visually inspected for damage after each test.
At least five equivalent samples should be tested, and the test can be conducted either in air at room temperature or under defined physiological conditions.
In the bubble emission test according to ASTM F2096, the integrity of packaging or sterile barrier systems is evaluated by applying internal pressure. For this purpose, the packaging film is punctured on one side using a needle, internal air pressure is applied, and the package is submerged in water. In our setup, a second needle and a digital manometer are used to directly measure the internal pressure.
To validate the procedure and to set the required internal pressure, a hole is intentionally introduced into the packaging using a 250 µm needle. The internal pressure is then adjusted until a continuous stream of air bubbles is produced.
We are pleased to perform leak testing of your packaging using the bubble emission test.
To evaluate the seal seam, dye is applied to one side of the seal. It is then visually examined whether the dye penetrates through the seal. Each side of the sample seal is observed for 5 seconds. The package must not contain liquids or condensation, as this could distort the test results. The dye used must provide strong contrast with the opaque packaging material. One of three methods is selected for seal testing.
Method A: Injection method
The dye solution is injected into the package. The seal is observed to detect possible seal defects indicated by dye leaking from the inside to the outside.
Method B: Edge immersion method
An outer edge of the seal is immersed in the dye solution. If dye penetrates from the outside to the inside, leakage points are present in the seal.
Method C: Pipette method
For this method, one outer edge of the package must remain unsealed. Using a pipette, drops of dye solution are applied to the inner side of the intact seal seam. The seal is then inspected for dye penetration.
The dimensions of the packaging are determined using a ruler.
The seal is visually inspected in the seam area for sealing defects, uniformity, and completeness.
The seal strength of the packaging seam is tested in a tensile test. The packaging is cut into samples of defined size. Both ends of the seal are clamped, with one of three clamping configurations selected depending on the type of seal. The specimen is statically loaded at 200 to 300 mm/min until seal failure occurs. Only results obtained using the same clamping configuration may be compared.
