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AQL

AQL (Acceptable Quality Level) is a statistically based sampling system that defines the maximum acceptable proportion of defective units in a production batch. It is applied in accordance with ISO 2859-1.

For medical single-use gloves under EN 455-1, AQL is applied to the water-leak test: examination gloves must achieve AQL 1.5; sterile surgical gloves must achieve AQL 0.65. A lower AQL value means fewer defects are permitted – AQL 0.65 is therefore a more demanding standard than AQL 1.5.

Importantly, AQL does not define how many units are tested. The sample size is determined separately by batch size and the inspection level (normal, tightened, or reduced) as defined in ISO 2859-1. AQL defines the acceptance criteria applied to that sample.

AQL is a batch-level statistical statement, not a measure of individual unit quality. A glove from an AQL 0.65 batch is not guaranteed to be defect-free – it means the batch as a whole meets the statistical acceptance threshold.

Outside gloves, AQL is applied across many industries wherever incoming goods inspection or batch release requires a standardised pass/fail criterion.

Frequently asked questions

What does AQL 1.5 mean for medical gloves?

AQL 1.5 is the maximum permitted defect rate for examination gloves under EN 455-1 water-leak testing. It means that statistically no more than 1.5 % of tested gloves may fail. Surgical gloves are held to the stricter standard of AQL 0.65.

Is a lower AQL value better or worse?

A lower AQL value means stricter quality requirements and is therefore better from a quality perspective. AQL 0.65 (surgical gloves) permits fewer defects than AQL 1.5 (examination gloves).

Does AQL apply only to gloves?

No. AQL is a general sampling system per ISO 2859-1 used across many industries. In medical devices and PPE, it is most commonly referenced for single-use gloves (EN 455-1) and chemical-resistant gloves (EN ISO 374-2).

What is the difference between AQL and sample size?

AQL sets the acceptance threshold for defects; it does not determine how many units are tested. Sample size depends on batch size and the chosen inspection level (normal, tightened, or reduced) under ISO 2859-1.