The EN 455 safety standard ensures medical grade gloves are robust and resistant to chemicals, bodily fluids and bacteria. Gloves that have not passed EN 455 inspection guidelines should not be considered safe for use in medical environments or for handling volatile substances. Clinical practitioners (vets included) must wear safety gloves to protect themselves and their patients.
EN 455 standards require all disposable nitrile gloves to undergo rigorous safety testing. This involves various tests of resilience and longevity. Every aspect of testing is vital because, without safe medical supplies, doctors can’t save lives. Yet, the technical details can be confusing, so this article explains the most important details.
What Does the EN 455 Safety Standard Mean?
Gloves with the EN 455 safety standard have been inspected and approved for use in environments with biological or chemical hazards. Testing includes four stages:
Stage 1 – Permeability assessment
Stage 2 – Assessment of physical qualities (resilience, flexibility, chemical resistance, etc)
Stage 3 – Assessment of toxicity (allergens, irritants, etc)
Stage 4 – Longevity assessment (use-by date)
Once passed, these four stages ensure (as far as possible) the gloves’ suitability for use in medical settings. They demonstrate an ability to safeguard against microorganisms and toxic and hazardous substances while retaining structural integrity.
Keep reading for more information on the individual stages.
Stage 1 – Permeability Assessment
For a glove to be safe, it’s outer surface must be completely impermeable. To test this, the gloves are filled with a litre of water. If a glove gives a particularly high AQL reading for microscopic holes, it is an immediate fail. Only medical supply gloves with an AQL score of 1.5 or less can pass the EN 455 standard.
In some specialist medical settings, only gloves with a score of 1.0 or 0.65 (or less) are approved for use.
Stage 2 – Assessment of Physical Qualities
Just as dangerous as a whole is a tear. The nitrile used to create disposable gloves is an interesting material because it manages to be flexible (one size fits all) and yet still strong enough to withstand pulling, snagging and other forms of tension.
Manufacturers have the difficult job of creating a comfortable glove that can be pulled on quickly without any risk of tearing. The material must be malleable enough to move like a second skin but also offer protection in all circumstances. Plus, it cannot impair a wearer’s dexterity or grip.
The EN 455 standard is used to assess many types of disposable glove, not just those intended for surgical supplies. Assessments of physical strength may vary depending on their application. For instance, surgical gloves are held to the highest standard and must tolerate up to nine newtons of force to be considered safe. Rubber gloves (including latex) must tolerate up to six newtons and thermoplastic (vinyl) gloves must tolerate up to 3.6 newtons.
Stage 3 – Assessment of Toxicity
The EN 455 safety standards also test the impact of nitrile, vinyl, latex and other common glove materials on skin. This is an important part of the inspection as it checks for any sensitivities that may make the gloves uncomfortable to wear.
Medical grade gloves are manufactured from a wide variety of chemicals, powders and plastics. Makers have a responsibility to prove these materials are safe. The potential risks posed by unsafe gloves include skin rashes, itching, dry skin and other types of an allergic reaction. More serious risks (developing a fever) are possible but extremely rare.
EN 455 requires all risks to the wearer to be negligible.
Chemical Residues – a test is performed to determine the number of chemical residues remaining after manufacture.
Latex – latex protein levels on the gloves are measured. The higher the volume of proteins, the greater the risk of skin irritations.
Powders – if medical supply gloves are marketed as ‘powder-free,’ the claim must be extensively tested. This claim is withdrawn if powder levels are higher than 2 mg per glove.
Endotoxin – surgical gloves must pass an endotoxin test to be considered sterile. Measurements below 20EU get a ‘low’ rating.
Stage 4 – Longevity Assessment
The last test is an assessment of longevity. It ensures gloves won’t degrade quickly and become unusable while dormant in storage. It also determines a use-by date for those materials such as latex which decay faster. Medical gloves of all varieties can be stored for five years after which unused stock must be discarded.
After this time, there is no guarantee the protective chemicals and materials offer the same degree of shielding they once did.
The Final Word On Medical Safety Standards
Medical gloves with the EN 455 standard have passed all the necessary assessments and are safe for use. This does not mean gloves can be used more than once if specifically designed for single-use applications. You should always follow the manufacturer’s safety recommendations.