prSRPS EN 455-4:2025

Medical gloves for single use - Part 4: Requirements and testing for shelf life determination

Scope

This part of EN 455 specifies requirements for shelf life for medical gloves for single use. It also specifies the requirements for labelling and the disclosure of information relevant to the test methods used. This document applies to existing, new and significantly changed designs. A definition of accelerated ageing conditions, as well as the test scope (i.e. what to test, sample size), shall be defined, under consideration of other similar international guidance documents.

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.