BS EN 455-1:2020 pdf free

BS EN 455-1:2020 pdf free.Medical gloves for single use Part 1: Requirements and testing for freedom from holes.
4 Requirement
Medical gloves for single use shall not leak when tested in accordance with Clause 5.
5 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 of the glove are tested shall be devised and implemented. Any modified process should not influence the viability of detection of holes.
NOTE 1 For example, the glove can be clamped to restrict the flow of water sequentially until all parts of the glove have been tested for the required time interval.
NOTE 2 Suggested dimensions of the filling tube are shown in Figure 1.
Attach the glove to the filling tube, overlapping the cuff by a maximum of 40 mm 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 (15 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.
Immediately inspect the glove visually for water leakage. Repeat the inspection after a period of 2 mm to 3 mm. Leakages within 40 mm of the cuff are not relevant.
5.2 Routine testing
Routine testing shall be either by the water tightness test given in Si. or by another test which is validated against this test.
6 Sampling, inspection level and AQL
Each lot shall be sampled statistically in accordance with standardized AQL (acceptance quality level) tables for single sampling plans using general inspection level I, but utilizing a minimum sample size and corresponding acceptance/rejection numbers equivalent to sample size code letter L. When tested by the method described in 51. for referee purpose, the compliance level for freedom from holes shall be an AQL of 0,65 for surgical gloves and 1,5 for examination gloves.
NOTE 1 Examples of standardized AQL tables can be found in ISO 28591 and ANSI/ASQ Z1.4.
NOTE 2 A minimum sample size equivalent to sample size code letter L ensures that an adequate assessment
of the quality of the lot is obtained when the lot size is small or unknown.
7 Test report
Any test report shall include at least the following information:
— a reference to this document (EN 455-1)
— the type of gloves and manufacturing batch code;
— the name and address of the manufacturer or distributor and test laboratory, if different;
— the date of the test performed;
— the test results (batch size, sample size, number of non-conforming gloves).BS EN 455-1 pdf download.