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Compliance at Mackwell Health

Mackwell Health manufactures high quality products utilising the latest technologies and we incorporate rigourous testing of each product to ensure they work first time and every time.  Our manufacturing processes are audited to  ISO 13485:2016.

Mackwell Group holds registration to ISO 14001:2015 (Licence Number EMS 516467), the standard that helps businesses minimise how their operations negatively affect the environment.

Mackwell Health is a member of the British Safety Industry Federation (BSIF).

UV-C Biovalidation to BS8628:2022

The BS8628:2022 standard was published in 2022 specifically for UV-C surface disinfection. It sets challenging targets against a range of organisms known to be highly resistant to UV-C disinfection.

Mackwell Health's surface disinfection devices: Microbox HD2, Minibox HD2, Tallbox HD2, and the Illuvi® Clean Light Room Disinfector are all 3rd party tested and verified to pass the requirements of BS8628:2022, which is now a requirement of the NHS environmental decontamination framework.

BS8628:2022 ensures that correct practices are followed for inoculation, recovery, and measurement of test organisms to ensure accurate reporting and avoid falsely misleading data, which can occur when chemical disinfectant standards are used to test UV-C performance.

The publication and adoption of BS8628:2022 is therefore a major step forward after more than 100 years without a recognised UV-C surface disinfection standard.

Testing at UKHSA

ProtectivAIR® has been rigorously tested at UKHSA Porton Down (formerly Public Health England), with highly successful results. Tests were done using virus-infected air actually passed through the ProtectivAIR® irradiation chamber and analysed in the UKHSA laboratory. Tests compared infected air, where the UV light source was switched off, with the same air with the UV switched on, and was also compared against a placebo sample fo pure, uninfected air.

In 100% of cases, the UV light prevented infections from being transmitted, and the level of inactivation on known surrogate pathogens was measured, allowing the delivered UV dose to be measured and applied to a range of other pathogens such as viruses, bacteria and spores.


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