BS EN 60601 (IEC 60601). This is essentially a design standard for manufacturers to ensure that equipment designed and produced for medical use are built and tested to a specific standard to ultimately ensure that patient safety is paramount from the design stage. It originated as a British Standard BS5724. As part of the production process all medical devices are rigorously tested to this design standard. The standard specifies the Type Testing Requirements for protection against potential electrical hazards including protective grounding, ground leakage currents, patient leakage currents, and patient auxiliary currents etc. Due to a lack of coherent policy on “Routine Testing” certain elements of the IEC 60601 Production Testing regimes were adopted for “Routine Testing”. HEI 95 and DB9801 also contain recommended testing standards for medical devices and the suggested test regimes are also utilised by BCAS Biomed. The current test standards have been derived to be consistent with the standards to which the equipment has been manufactured. They have been modified from the standards with the strict proviso that such tests do not damage or stress the equipment under test.

IEC 62353. This standard aims to provide a uniform standard that ensures safe practice and reduces the complexity of IEC60601 Production standards. It defines the requirements for ensuring the safety of medical electronic devices used in the treatment, care and diagnosis of patients. It recognises the laboratory conditions described in IEC 60601 cannot always be guaranteed when carrying out routine or repair testing, and that some type testing carried out on a routine basis can be destructive over a period of time.