EN 455-2
EN 455-2 sets requirements for the physical properties of medical single-use gloves as part of the EN 455 series.
Parameters tested:
1. Dimensions: length and width per size (XS to XL), minimum length by glove type
2. Force at break: minimum requirements before and after ageing
- Sterile surgical gloves: minimum 9.0 N
- Latex and nitrile examination gloves: minimum 6.0 N
- Thermoplastic examination gloves (vinyl/PVC, PE): minimum 3.6 N
3. Elongation at break: EN 455-2 sets no normative minimum for elongation. It is determined as a material property per ISO 37; binding elongation limits appear instead in ASTM standards (e.g. ASTM D3578 for latex examination gloves)
Ageing test: mechanical properties are tested both before and after simulated ageing (accelerated heat treatment). This ensures the glove retains adequate mechanical integrity up to its expiry date.
EN 455-2 is closely linked to EN 455-4 (shelf life): the ageing conditions in EN 455-2 form the basis for determining expiry dates in EN 455-4.
Frequently asked questions
What tensile strength does EN 455-2 require for nitrile gloves?
EN 455-2 requires a minimum tensile strength of 6 N for nitrile gloves - both before and after the ageing test. Vinyl gloves must reach at least 3.6 N.
Does EN 455-2 also specify elongation at break?
No. EN 455-2 specifies dimensions and force at break, not elongation. Elongation is determined as a material property under ISO 37; normative minimum values for it appear in ASTM standards rather than in EN 455-2.
Why are physical properties tested before and after ageing?
The ageing test simulates natural material degradation during storage. Gloves must still meet minimum requirements after simulated ageing to ensure product safety up to the expiry date.