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EVS-EN 455-3:2023

Medical gloves for single use - Part 3: Requirements and testing for biological evaluation

General information
Valid from 15.12.2023
Base Documents
EN 455-3:2023
Directives or regulations
None

Standard history

Status
Date
Type
Name
15.12.2023
Main
07.05.2015
Main
EN 455-1 specifies requirements for the evaluation of biological safety for medical gloves for single use. It gives requirements for labelling and the disclosure of information relevant to the test methods used.

Adverse reactions to proteins in latex products have been reported over several years in variable rates of prevalence. Additionally, adverse reactions due to chemicals, lubricants, sterilization residues, pyrogens or other residues are described in scientific literature.

Adverse reactions are most often reported due to gloves made from natural rubber latex, but some of the reactions can also be seen due to gloves made from synthetic polymers. These adverse reactions occur to specific allergens that can be present in gloves. Several factors contribute to the risk of reaction:

a) the duration and frequency of skin contact with gloves,

b) the exposure to the allergens through direct contact with mucosa and skin (especially when not intact) and by inhalation of particles,

c) the occlusive nature of the glove or skin interaction during glove use.
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