In order to have the device compliant to the European Regulation 2017/745 we must be compliant to IEC 60601-1 and ISO 10993.
The IEC 60601-1 shows the general requirements for eletrical security for medical device with active parts.
The tests are Type Tests (according to subclause 5.1), that use a representative sample for the tests (see subclause 5.2), with normal use conditions (20 - 30 °C) (according to subclause 5.3 and subclause 5.7). Then the device is to be tested under the least favourable working conditions (according to subclause 5.4).
Relatively to the currents limits we have (according to subclauses 8.7.1, 8.7.2, 8.7.3):
- To test leakege currents and patient auxiliary currents verify the allowable value (see the table 1), The values of a.c. apply to currents having a frequency not less than 0,1 Hz.
- The allowable values of the touch current are 100 μA in normal condition and 500 μA in single fault condition.
- The allowable values of the earth leakage current are 5 mA in normal condition and 10 mA in single fault condition.
Determination of Applied Parts and Accessible Parts (according to subclauses 5.9.1, 220.127.116.11 and 18.104.22.168):
- Applied Parts: are identified by inspection
- Accessible Parts: by inspection or:
- Test Finger: Test with a particular probe at 30 N.
- Test Hook: test with a force of 20 N for 10 s, perpendicular to the surface.
Table 1 - Allowable values of patient leakege currents and patient auxiliary currents. (According to 8.7.3 table 3)
Relatively to ISO 10993-1 "Biological evaluation of medical device - Part 1: Evaluation an testing within a risk management process." Annex A (table A.1) shows that Cytotoxicity, Sensitization and Irritation or intracutaneous reactivity tests must be carried out for ours device, because it is a surface device, in contact with the skin and it has limited contact duration.
Table 2 - Biocompatibility test (Annex A table A.1)