TS EN 455-3 Disposable Medical Gloves - Biological Evaluation

The EN 455-3 standard, which describes the requirements and test methods for biological evaluation of disposable medical gloves, is actually a European standard. This standard describes the requirements for the evaluation of biological safety for disposable medical gloves as well as information on labeling and test methods used.

The EN 455 standard set is a series of standards, consisting of the following four sections, under the general heading of disposable medical gloves. This series of standards has been published in our country by the Turkish Standards Institute (TSE) with the following titles:

• TS EN 455-1 Part 1: Properties and no hole test
• TS EN 455-2 Part 2: Rules and experiments for physical properties
• TS EN 455-3 Part 3: Properties and experiments for biological evaluation
• TS EN 455-4 Part 4: Rules and experiments for determining shelf life

The most complex of this series is the EN 455-3 standard. It describes the different areas that are important for conducting a biological assessment, and includes numerous test methods and different requirements. Although this standard is generally considered to cover only latex gloves, it applies to all types of medical gloves.

Biological assessment is at the top of the tests to see if the glove will increase the risk of sensitization or disturb the user. The dust level of a powder-free glove should be tested according to the method described in the ISO EN 21171 standard. The powder level of a powder-free glove should not exceed 2 mg. In addition, the endotoxin level of a sterile glove is tested.

It is necessary to make sure that the glove used does not make the person sick. Substances that irritate the skin should be as low as possible. Because there is always a risk of reacting to gloves and this risk should be low.

Within the scope of protective clothing tests, our institution also provides TS EN 455-3 disposable medical gloves biological assessment test services.