Breathalyzer product approvals

It is often difficult to know where to start when deciding what breathalyzer is right for you. 

For a start, what do all the approvals and certifications mean? Some may apply to your use of a breathalyzer more than others; some apply specifically to the breathalyzer accuracy and purpose of use. 

Below are some brief definitions to help you. If you need any further advice on breathalyser approvals, please contact us.

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 Police Approved

A breathalyzer with approval to be used by the UK Police will have Home Office Approval for police use. This means that the police in the UK may either use the device at the road side or at the police station.  This 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 selling non-approved devices, so be sure to double check.

Home Office Approval

This means that the UK Home Office have deemed the device suitable for Police and Law Enforcement use (see above). As yet only fuel cell, fixed-volume sampling devices like the Draeger 6820 have so far been approved. While a minimum standard for personal breathalyzers would be highly desirable, at the moment nothing exists and as a result many low-cost devices sold on the UK market are little more than novelty items.

EN Approval

European Standards (ENs) are not legal documents but 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.  Some of our breathalyzers have a specific EN approval number which can be looked up to know what standards it conforms to, for example EN 50436 is for a vehicle interlock.

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 our own Home Office Approval scheme.

NHTSA

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.

Professional approvals such as 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 breathalyzers are not good enough for it, it may just mean the product 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.