BS EN 455-1:2020 pdf download
BS EN 455-1:2020 pdf download.Medical gloves for single use Part 1: Requirements and testing for freedom from holes.
This document specifies requirements and gives the test method for medical gloves for single use in order to determine freedom from holes.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases (or use in standardization at the following addresses:
— ISO Online browsing platform: available at https://wwwiso.org/obpJ
— IEC Electropedia: available at hlip://www.electrupedaurg/
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 rocedure.
3.2
hole
defect of the glove which allows leakage of water
4 RequIrement
Medical gloves for single use shall flat leak when tested in accordance with ClauseS.
5 Water tightness test for detection of holes
5.1 Referee testing
Vertically position a filling tube of suitable dimensions to lit 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 0 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 I For example, the glove can be clamped to restrict the [low 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 of4O mm over the end of the tube and secure it by suitable means to obtain a watertight seal without damaging the glove (see Eigurei).
Add (1 000 ± SO) ml of water at a temperature of (15 to 3S) °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 miii. 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 51. 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/reectlon numbers equivalent to sample size code letter L. When tested by the method described in 51. (or referee purpose, the compliance level for freedom from holes shall bean AQI of 0,65 for surgical gloves and 1.5 for examination gloves.
NOTE I Examples of standardized AQL tables can be lound in ISO 28591 and ANSI/ASQ Zl.4.
NOTE 2 A minemum sample size equivalent to sample size code letter I 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 (ENASS4);
— the type of gloves and manufacturing batch code
— the name and address of the manufacturer or distributor and test laboratory, II different;
— the date of the test performed;
— the test results (batch size, sample size, number of non-conforming gloves).
