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What is EN 455?
EN 455 is a series of technical standards, not a standalone market authorisation. For gloves intended as medical devices in the EU, determine the applicable Medical Device Regulation obligations and conformity assessment route. Check the precise references in the European Commission's harmonised standards publications. Their use is voluntary; cited standards support presumption of conformity only for the requirements they cover.
EN 455 parts 1–5 at a glance
The BSI series catalogue now lists five parts. Older summaries that describe only four omit the publication on extractable chemical residues. Verify current editions and amendments separately for each part.
| Part | Subject | Evidence to identify |
|---|---|---|
| EN 455-1 | Freedom from holes | Test method, sampling plan and lot identification |
| EN 455-2 | Physical properties | Results for the relevant glove type and tested condition |
| EN 455-3 | Biological evaluation | Evaluation and test evidence relevant to the material and claims |
| EN 455-4 | Shelf-life determination | Evidence supporting the stated expiry and storage conditions |
| EN 455-5 | Extractable chemical residues | Applicable chemical-residue assessment and test records |
What does AQL mean for medical gloves?
AQL means acceptance quality limit. It is used to select an acceptance-sampling scheme; it is not a guarantee of the percentage of defective gloves in a delivered box. For example, an AQL label of 1.5 does not mean that 1.5% of every sample may simply fail.
The lot size, inspection level and applicable sampling plan determine the sample and acceptance/rejection numbers. Ask for the complete plan and results rather than comparing the AQL number alone. ISO's explanation of acceptance sampling describes why these procedures do not verify a guaranteed quality level for every individual lot.
EN 455 versus EN ISO 374
EN 455 concerns single-use medical gloves. The ISO 374 family concerns protective gloves against specified dangerous chemicals and microorganisms; see the ISO 374-5 catalogue scope for microorganism risks. A medical-glove claim alone does not establish protection against a particular chemical.
Identify whether the manufacturer intends the glove for medical use, wearer protection as personal protective equipment, or both. Products with both purposes may need to satisfy both regulatory frameworks. Review the actual claimed protection, test results, limitations and instructions rather than treating the markings as interchangeable.
A document checklist for buyers and manufacturers
- Identify the product: manufacturer, model, material, sizes, sterile or non-sterile presentation and intended purpose.
- Record the references: full standard numbers, editions and amendments, with any relevant EU citation restrictions.
- Match the evidence: confirm that reports apply to the supplied glove and relevant manufacturing configuration.
- Check sampling and testing: identify lots, sample sizes, methods, results and acceptance criteria.
- Review labelling: intended use, limitations, storage, expiry and relevant regulatory documentation.
- Control changes: consider whether material, manufacturing or packaging changes require updated evidence.
Find the applicable documents
Search the Genorma catalogue for EN 455 and confirm the required parts, edition, language, licence and price with the supplier. A document purchase is separate from testing or certification.
Frequently asked questions
Does EN 455 guarantee a fixed shelf life?
No single expiry period should be assumed for all gloves. The manufacturer needs evidence supporting the declared shelf life and storage conditions for the product.
Does a low AQL prove every glove is free of holes?
No. Acceptance sampling evaluates a sample under a defined plan and has statistical limits.
Does EN 455 alone demonstrate chemical protection?
No. Check the specific protective claim and applicable chemical testing evidence.