BS EN 455-1:2020 pdf download.Medical gloves for single use Part 1: Requirements and testing for freedom from holes.
3.1
medical gloves for single use
gloves intended for use In the medical field to protect patient and user from cross-contamination. intended to be used on one individual during a single procedure
NOTE Medical gloves labelled as single use are medical devices for single use according to the Medical Device Regulation (MDR). A single use medical device means a device that is intended to be used on one individual during a single procedure.
hole
defect of the glove which allows leakage of water
4 Requirement
Medical gloves for single use shall not leak when tested in accordance with Clause 5.
S Water tightness test for detection of holes
5.1 Referee testing
Vertically position a filling tube of suitable dimensions to fit the glove such that the tube and the glove is capable of holding 1 000 ml of water. If. due to extension of the glove, the 1000 ml does not completely fill the glove, a means of ensuring that all parts ofthe glove are tested shall be devised and implemented. Any modified process should not influence the viability of detection of holes.
NOTE I For example, the glove can be clamped to restrict the flow of water sequentially until all parts of the glove have been tested fur the required time interval.
NOTE 2 Suggested dimensions of the tilling tube are shown in £igurcl.
Attach the glove to the filling tube. overlapping the cuff by a maximum of 40mm over the end of the tube and secure It by suitable means to obtain a watertight seal without damaging the glove (see Figure 1).
Add (1 000 ± 50) ml of water at a temperature of (IS to 35) °C into the open end of the filling tube, allowing the water to pass freely Into the glove to ensure an equal distribution into each finger Some of the water may remain in the filling tube depending on the glove being tested.
medical gloves for single use
gloves intended for use In the medical field to protect patient and user from cross-contamination. intended to be used on one individual during a single procedure
NOTE Medical gloves labelled as single use are medical devices for single use according to the Medical Device Regulation (MDR). A single use medical device means a device that is intended to be used on one individual during a single procedure.
hole
defect of the glove which allows leakage of water
4 Requirement
Medical gloves for single use shall not leak when tested in accordance with Clause 5.
S Water tightness test for detection of holes
5.1 Referee testing
Vertically position a filling tube of suitable dimensions to fit the glove such that the tube and the glove is capable of holding 1 000 ml of water. If. due to extension of the glove, the 1000 ml does not completely fill the glove, a means of ensuring that all parts ofthe glove are tested shall be devised and implemented. Any modified process should not influence the viability of detection of holes.
NOTE I For example, the glove can be clamped to restrict the flow of water sequentially until all parts of the glove have been tested fur the required time interval.
NOTE 2 Suggested dimensions of the tilling tube are shown in £igurcl.
Attach the glove to the filling tube. overlapping the cuff by a maximum of 40mm over the end of the tube and secure It by suitable means to obtain a watertight seal without damaging the glove (see Figure 1).
Add (1 000 ± 50) ml of water at a temperature of (IS to 35) °C into the open end of the filling tube, allowing the water to pass freely Into the glove to ensure an equal distribution into each finger Some of the water may remain in the filling tube depending on the glove being tested.
