EN455 Medical Gloves for Single Use. Part 1 Requirements and Testing for Freedom From Holes
Gloves must pass this test in order to prove that they are an effective barrier against micro-organisms. A statistical sample taken from a batch of gloves is subject to checks for pinholes and leaks by filling with water. Gloves must achieve an acceptable quality levels (AQL) of 1.5 or better in order to be used as examination, procedure or surgical gloves.
AQL1.5 is equivalent to a maximum risk of 1.5% that any given glove contains a pinhole capable of allowing water, and therefore micro-organisms, through the film.
EN455 Medical Gloves for Single Use. Part 2 Requirements and Testing for Physical Properties
This standard includes tests for glove dimensions, and physical strength. Gloves are treated differently depending on the use they are intended for and the material they are manufactured from.
|Surgical Gloves||Examination/Procedure Gloves made of Rubbers||Examination/Procedure Gloves made of Thermoplastics (e.g. Vinyl)|
|Force at Break Throughout Entire Shelf Life||9.0||6.0||3.6|
EN455 Medical Gloves for Single Use. Part 3 Requirements and Testing for Biological Evaluation
This standard includes tests for potentially hazardous materials that may affect the wearer or be transferred to a patient. These materials include:
- Endotoxins: Toxic materials left behind by certain bacteria that can cause fever in humans
- Latex Proteins: Because natural rubber latex is a natural product it contains proteins and enzymes that can cause a severe allergic reaction in genetically predisposed people
- Chemical Residues: Most commonly, accelerators used in the manufacture of the product itself. These can cause allergic dermatitis in some genetically predisposed individuals
- Powder: A powder free medical glove should have a powder level of <2mg per glove
The materials above are tested individually as well as collectively, through the use of limited animal testing according to a separate standard, ISO10993.
EN455 Medical Gloves for Single Use. Part 4 Determination of Shelf Life
This standard requires a complicated network of tests to determine how long a glove will be fit for use when stored in warehouses or in end-user store rooms. All calculations based on this testing must be checked by comparison to samples aged in real-time as soon as those samples become available. The maximum shelf-life that can ever be claimed for medical gloves is five years from the date of manufacture.