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.
Registration number (WIID)
82384
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.
