This standard specifies requirements and tests for gloves for medical purpose. Requirements are detailed in the Medical Device Directive 93/42/EEC. This includes tests to assess the freedom from holes, the dimensions of the gloves and the mechanical strength of its materials, both before and after an ageing process.

Part 1

EN 455-1 covers requirements and testing of gloves for being free of holes. For this test the standard uses a water leak test to which randomly sampled gloves are subjected. A statistical sample taken from a batch must achieve an acceptable quality level (AQL) of 1.5 or better to be used as examination, procedure, or surgical gloves. AQL 1.5 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 material.

Part 2

EN 455-2 describes the testing requirements for determination of physical properties, including the tensile strength, before and after accelerated ageing, of medical gloves. Gloves are treated differently depending their intended use and the material they are manufactured from.

Part 3

EN 455-3 covers requirements and testing for biological evaluation. It specifies methods for protein testing (extractable latex proteins have an important role in latex allergy), powder levels, and endotoxin levels.

Part 4

EN 455-4 covers requirements and testing for shelf life determination. It specifies real-time and accelerated shelf life studies, to enable manufacturers to prove that their product will withstand up to 3 years (usually) without losing their properties as well as complying with the requirements of the EN 455.