prEN 455-4 rev

Medical gloves for single use - Part 4: Requirements and testing for shelf life determination prEN 455-4 rev

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 legislation

Legislation related to this standard