Breathalyser product approvals

Depending on their type of use, breathalysers can have different approvals and certifications from worldwide organisations.

Here is an overview of some that might be important to you when choosing a breathalyser. If you need any further advice on breathalyser approvals or selecting a suitable device, please contact us or try our quick guide to helping you choose.

CE Certificate

A breathalyzer with a CE certificate and bearing the CE marking has ‘European Conformity’. This means it complies to all the essential Health, Safety and Environmental requirements established by the European Standards Agencies.

UK Home Office Approved

A breathalyser with approval to be used by the UK police force will have Home Office Approval for police use at the road side or at a police station. The Dräger Alcotest 6820 Breathalyzer and Dräger Alcotest 7510 Breathalyzer are both UK Home Office Approved devices and are used by the British police.

This approval also applies to some drug testing kits as of 2015.

You can ask your supplier for the approval certificate to confirm that the device is actually used by UK police – the term ‘UK Police Breathalyzer’ is often mis-used in many online marketplaces by unscrupulous sellers who are actually supplying non-approved devices, so be sure to double check. While a minimum standard for personal breathalysers would be highly desirable, at the moment nothing exists and as a result many low-cost devices sold on in the UK market are little more than novelty items.

EN Approved

European Standards (ENs) are not legal documents but are sometimes are used by governments to set laws. They are documents that have been confirmed by one of the three European Standardization Organizations (ESOs), CEN, CENELEC or ETSI.  Most of our breathalysers have a specific EN approval number which can be used to confirm the standard it conforms to, for example EN 50436 is for a vehicle interlock.

OIML Certified

OIML (Organisation Internationale de Métrologie Légale) is an Accreditation Body that defines international standards, and is recognised throughout the world.  It is the highest level of recognised certification for handheld alcohol testers.

RoHS Compliant

RoHS stands for Restriction of Hazardous Substance and affects many electronic products. If a product is RoHS compliant then it has been checked for hazardous materials and been cleared. Most CE products should also be RoHS compliant.

FDA Approval

This specifically relates to the US Food & Drug Agency Approvals as used in the United States.  For breathalyzers this means they are approved medical devices by the FDA.  The FDA approves a variety of things to protect public health.

DoT Alcohol Screening Devices (ASD)

DoT stands for Department of Transport, and is specifically used in the United States.  Devices with this status satisfy the requirement to screen for alcohol but make no claims as to the accuracy of the readings.

DoT Evidential Breath Tester (EBT)

Another approval specifically targeted at the United States.  Devices with this status are units are recognised for both their accuracy and reliability and recommended for evidential breath testing in the US.  This is the closest US certification to the UK Home Office Approval scheme.

NHTSA Evidential Approval

National Highway Traffic Safety Administration (NHTSA) set specifications for alcohol testers so they can be considered as an Evidential Breath Tester.  A breathalyzer with this status conforms to that.

It is worth noting that professional approvals such as UK Home Office Approval or US DoT EBT Approval are awarded when the product has been put forwarded for testing and analysis – at the manufacturer’s cost. This doesn’t always mean other breathalysers are not good enough for it, it may just mean the device has not been submitted for approval by that specific approval body.

If you have any queries regarding the approvals relating to your device, please contact us.