Why MEST isn’t PAT and why that’s important to your patient safety & clinical efficacy
No UK industry is required to observe higher standards for equipment safety procedures than the healthcare sector. The IEC’s 60601 “Medical Electrical Equipment—General Requirements for Safety” was introduced in 1977 and put forth a set of requirements to detect and eradicate any potential electrical hazards such as leakage currents and protective grounding. Its successor IEC 62353 “Safety Testing of Medical Devices” was introduced in 2014 and adds additional test requirements post-repair and maintenance. This standard is incorporated into UK & European law as BS EN 52363.
Safety testing of medical devices should not be confused with portable appliance testing. Not only are medical devices more sensitive than standard electrical appliances, IEC BS EN 62353 test procedures ensure that elements of medical devices attached to patients are also safety-tested, unlike standard portable appliance test procedures.
So to be sure that your Surgery is procuring best-in-class safety testing that fully enables you to evidence CQC inspection and audit processes, make sure your equipment inspection and calibration provider is fully trained and accredited to IEC BS EN 52363 standards like JPen Medical.
Are you visiting Best Practice 2018? Why not stop by stand L51, have a coffee and learn more about how the UK’s leading experts in medical equipment safety testing can support your Surgery. Or get in touch by email firstname.lastname@example.org