EN 455-4
EN 455-4 is the fourth part of the EN 455 series and addresses the shelf life of medical single-use gloves.
Core requirement: gloves must meet all requirements of EN 455-1 (leak resistance) and EN 455-2 (physical properties) up to their expiry date under the stated storage conditions.
Ageing testing:
- Accelerated ageing by heat treatment (e.g. 70 degC for 7 days equates to a defined real-time storage period)
- The Arrhenius equation is used to correlate accelerated and real-time ageing
- Real-time ageing is the most precise method but takes correspondingly longer
Expiry date:
- Based on the results of ageing tests
- Indicates until when product safety is guaranteed under correct storage
- Typical for medical single-use gloves: 3-5 years
Storage conditions: EN 455-4 defines reference storage conditions (temperature, humidity, light protection). Deviations can shorten shelf life - e.g. UV exposure or extreme temperatures.
Frequently asked questions
How is the expiry date for medical single-use gloves determined?
The expiry date is based on ageing tests per EN 455-4. Accelerated ageing (heat treatment) or real-time ageing is conducted. The manufacturer must demonstrate that the glove meets EN 455-1 and EN 455-2 requirements up to the stated date.
What happens if gloves are stored incorrectly?
Incorrect storage conditions (extreme heat, UV exposure, humidity) can accelerate material degradation and shorten actual shelf life. The expiry date is valid only under correct storage as specified by the manufacturer.
Must the expiry date appear on the packaging?
Yes. The expiry date is a mandatory labelling requirement for medical single-use gloves under MDR (EU) 2017/745 and EN 455-4. It is indicated using the 'use by' symbol (hourglass) or year/month format.