BS EN 455 – European Standard for Medical Gloves
In order for a product to be used in a medical environment, it is essential that the product meets the tough requirements of the EN 455 test.
BS EN 455-1: 2020 Freedom from holes.
Testing for this standard uses a water leak test that is carried out using AQL statistical sampling techniques based on production batch sizes. Gloves used in a medical setting require an AQL of 1.5, which is a maximum of 1.5% product failure.
This is important in the real world, as this helps to reassure users that the gloves are thoroughly checked for holes, providing an effective barrier from exposure to chemicals or biological contaminants, when they need protection.
BS EN 455-2: 2015 Physical Properties.
This covers testing such as dimensions (length & width) and force at break both before and after heat ageing.
This testing ensures that Gloves conform with uniform sizing specifications, so that the correct size can be selected by the user. The force at break is important to ensure that gloves are strong enough for their appropriate use, and that users can don and use the gloves with confidence. Whilst the actual physical testing requirements of the glove depend on the specification and material that the glove is made of, this testing ensures the user receives good quality product.
BS EN 455-3: 2015 Biological evaluation.
Biological evaluation of endotoxins, powder residue and leachable proteins is important in safeguarding the user’s skin health during use. Endotoxins is a measure of chemicals left by harmful bacteria, and is important to surgical gloves.
Powder free gloves should ensure less than 2mg powder per glove, to ensure that the glove is suitable for that claim.
Measurement of leachable proteins is relevant for Natural Latex products, which have natural proteins and enzymes, where it is well documented that susceptible individuals may have allergic skin reactions during use of the gloves.
Chemical residue testing, commonly using ISO10993, ensures that users skin is not exposed to harmful chemicals during wearing of the glove. Chemicals can cause skin reactions and dermatitis (Type IV allergic reactions) in susceptible individuals.
BS EN 455-4: 2009 Requirements and testing for shelf-life determination.
It is important to test the shelf life of products, so that an effective expiry date can be given. This gives users confidence that the glove will be of good quality whilst in date.
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