TESTING AND MEASURING EQUIPMENT/ALLOWED SUBCONTRACTING
IEC 60601-2-2:2017+AMD1:2023, Edition 6.1
Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
Download IEC 60601-2-2-2017 standard
| Clause | Measurement/testing | Testing / measuring equipment / material needed | Equipment |
| 201.8.4.101 | Neutral electrode monitoring circuit | Test setup as per Figure 201.103, sound level meter | |
| 201.8.4.102 | Neuromuscular stimulation | Capacitance meter, dc resistance meter |
KP8850ESU Analyzer |
| 201.8.5.1.2 | MOPP | Caliper, high voltage tester |
|
| 201.8.5.2.3 | Patient leads | Caliper, high voltage tester |
|
| 201.8.7.3.101 | Thermal effect of HF leakage current | RF ammeter, load and measuring resistors, tape measure, setup according to figures 201.104 – 201.107 |
|
| 201.8.8.3.101 | Active accessory insulation | saline solution, caliper, timer |
|
| 201.8.8.3.102 | Active accessory HF leakage | saline solution, caliper, HF voltage source, RF ammeter, HF capacitance meter, tape measure |
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| 201.8.8.3.103 | Active accessory HF dielectric strength | saline solution, HF voltage source , caliper, porous cloth, metal foil, timer |
|
| 201.8.8.3.104 | Active accessory mains frequency dielectric strength | saline solution, HF voltage source , caliper, porous cloth, metal foil, timer |
|
| 201.8.10.4.2 | Connection cords | Cord anchorage test apparatus as per Figure 201.108, aperture, weights, tape measure, dc source, ammeter | |
| 201.8.10.4.101.4 | Footswitch | Force gauge (force ≥ 10N) applied over an area of 625 mm2 | |
| 201.11.6.3 | Spillage | Measuring cup (1liter), timer, high voltage tester | |
| 201.11.6.5 | Ingress of water or particulate matter | saline solution, caliper, timer, impedance analyser or other suitable devices for measuring ac impedance | |
| 201.11.8 | Interruption of the power supply | Electrosurgical analyser or other suitable devices to measure output power | |
| 201.12.1.101 | Accuracy of output control setting | Electrosurgical analyser or other suitable devices to measure output power, oscilloscope, various load resistances, setup as per Figures 201.109 and 201.110 | |
| 201.12.1.102 | Monotonicity of output control setting | Electrosurgical analyser or other suitable devices to measure output power, oscilloscope, various resistances, setup as per Figures 201.109 and 201.110 | |
| 201.12.1.103 | Accuracy of maximum output voltage | Oscilloscope | |
| 201.12.4.2 | Indication of parameters relevant to safety | Electrosurgical analyser or other suitable devices to measure output power | |
| 201.12.4.2.101 | Output indicator | Frequency analyser, sound level meter, tape measure | |
| 201.12.4.3.101 | Output reduction means | Electrosurgical analyser or other suitable devices to measure output power | |
| 201.12.4.4.101 | Maximum allowed output power in single fault condition | Electrosurgical analyser or other suitable devices to measure output power | |
| 201.12.4.4.102 | Output power during simultaneous activation | Electrosurgical analyser, RF ammeter or other suitable devices to measure output power and HF current, test setup as per Figure 201.111 | |
| 201.13.2.13.101 | Protection against the effects of short-circuiting of the electrodes | Timer | |
| 201.15.4.1.102 | Retention of detachable active electrodes | Pull tester, timer | |
| 201.15.101.2 | NE cord attachment | DC or mains frequency, ammeter | |
| 201.15.101.3 | NE cord connector, no conductive parts on patient | Test finger as per Figure 6 of general standard | |
| 201.15.101.4 | NE cord insulation | Tests as per 201.8.8.3.102a), 201.8.8.3.103, 201.8.8.3.104 | |
| 201.15.101.5 | NE thermal performance | HF voltage source, RF Ammeter, temperature scanning apparatus, caliper, environmental chamber (23±2°C), human subjects or surrogate medium or test device as defined in this clause, timer |
|
| 201.15.101.6 | NE contact impedance | HF voltage source,
20cm x 30 cm flat metallic plate, true r.m.s., |
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| 201.15.101.7 | NE adhesion | Timer, pull tester, caliper, 0.9% saline solution |
