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Standards Development
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 European Standard 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.
The use of the Arrhenius equation for these gloves is appropriate (unlike with condoms, which are stored in foil packets) as the ageing process is thermo-oxidative. Therefore, the general principle of EN 455-4 shall not be touched in the upcoming revision (historical data shall not be deleted). However, an optional method for accelerated aging should be added and it is worthwhile considering the approach of ASTM D7160, e.g.
new section for synthetic gloves as an alternative to the Arrhenius equation (see ASTM D7160, 6.4.2 and 7)
ASTM specifies sample size
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