EN 455-1
EN 455-1 governs the leak resistance requirements for medical single-use gloves as part of the four-part EN 455 series.
Test procedure (water leak test):
- Gloves are filled with 1,000 ml of water and sealed
- Suspended storage for a defined test period
- Leaking gloves (visible water loss) are counted as defects
Acceptance limits per AQL (ISO 2859-1):
The AQL value determines the maximum acceptable defect rate in sampling inspection based on batch size. AQL 0.65 is stricter than AQL 1.5.
EN 455-1 tests only for macroscopic defects (holes, tears). Chemical permeation through intact material is not covered by EN 455-1 - EN 16523-1 applies for that.
EN 455-1 is methodologically equivalent to the penetration test in EN ISO 374-2 but is specifically standardised for medical single-use gloves as medical devices.
Frequently asked questions
What does the water leak test per EN 455-1 check?
The water leak test checks for macroscopic defects (holes, tears). Each glove is filled with 1,000 ml of water. Gloves showing water loss are defective. Acceptance limit: AQL 1.5 (examination) or AQL 0.65 (surgical).
Why does AQL 0.65 apply to surgical gloves and AQL 1.5 to examination gloves?
Surgical gloves are used in invasive procedures where contamination can enter open wounds directly. The higher infection risk justifies stricter leak resistance requirements.
Does EN 455-1 also cover chemical protection?
No. EN 455-1 tests only for water leak-tightness (macroscopic defects). Chemical protection (permeation) is tested separately per EN 16523-1, which applies to gloves under EN ISO 374.