We are pleased to announce two updates to our UKAS schedule.
Firstly, we are now UKAS accredited for EN 60601-1-11:2015, which covers the requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment. This standard considers that equipment will be used by an untrained operator or a trained healthcare professional in an environment that is not controlled in the way a professional one is. We have extensive knowledge and experience in medical device testing and so are proud to have this recognition from UKAS.
We are also now UKAS accredited for the new standard for Information Technology Equipment (ITE) and Audio/Video equipment EN 62368, which replaces EN 60950-1 and EN 60065. As technology has developed it has become harder to ascertain when a product is no longer ITE and becomes audio/video and this has led to the new standard being introduced, which covers both ITE and audio/video associated equipment.
As of December 2020, manufacturers must ensure that audio/video and ITE components and products conform to the new standard, while EN 60950-1 and EN 60065 will be formally withdrawn, with no grace period.
It is worth remembering, that this standard also covers components and therefore even the power supply must be compliant with EN 62368. If your product or components are already certified to either EN 60950-1 or EN 60065 then it must be retested to EN 62368. As a UKAS accredited laboratory we can help manufacturers ensure their product is compliant in time for the new standard to take effect.
