Specification builder · Tier B
Medical electrical safety analyser for IEC 62353 recurrent tests and IEC 60601-1 leakage tests, with ECG / performance simulation options
A medical electrical safety analyser measures protective earth resistance, insulation and leakage currents of medical devices to show they cannot give a patient or user an electric shock. Hospital biomedical engineering departments use it for acceptance, yearly and after-repair checks to IEC 62353, and device testing laboratories and manufacturers use it for IEC 60601-1 leakage tests. The analyser itself is laboratory test equipment (IEC 61010-1), not a medical device.
What this equipment will do
- Device types: mains-powered medical electrical equipment and systems, Class I and Class II, with type B, BF and CF applied parts (patient connections), such as monitors, ECG machines, suction units, warmers and beds (IEC 62353).
- Device types: 12-lead ECG machines and multi-parameter monitors tested with all patient leads connected in one sequence. (with the optional module)
- Device types: three-phase medical equipment up to 32 A. (with the optional module)
- Protective earth resistance at 200 mA and insulation resistance at 500 V DC (IEC 62353).
- Equipment and applied-part leakage current by the direct, differential and alternative methods, with automatic pass/fail (IEC 62353).
- Leakage currents of IEC 60601-1 clause 8.7: earth, touch (enclosure), patient and patient auxiliary leakage and mains on applied part, under normal and single fault conditions (open neutral, open earth, reversed polarity). (with the optional module)
- Mains on applied part at 110% voltage built in, and preset limits for NFPA 99, AS/NZS 3551 and IEC 61010-1. (with the optional module)
- High-current protective earth test at 10 A / 25 A, as used for IEC 60601-1 type and production tests (clause 8.6). (with the optional module)
- Dielectric strength (hipot) test up to 5 kV AC for IEC 60601-1 type tests. (with the optional module)
- Supplying the device at 110% of its rated voltage during IEC 60601-1 leakage and power-input type tests. (with the optional module)
- ECG and performance waveforms to check that ECG machines and monitors read correctly after the safety test. (with the optional module)
- Simulation of respiration, invasive and non-invasive blood pressure, temperature and SpO2 for checking multi-parameter monitors. (with the optional module)
Not covered: Output and performance checks of specific devices (defibrillator energy, electrosurgical unit power, infusion pump flow, ventilator flow and pressure) need a defibrillator analyser, electrosurgical analyser, infusion device analyser or gas flow analyser.; Electromagnetic compatibility (EMC) testing of medical devices (IEC 60601-1-2) needs an EMC test laboratory with a shielded chamber.; Testing of the hospital's own wiring, sockets and isolated (IT) power systems needs an electrical installation tester (IEC 60364-7-710).
Loading the builder...
Standards this specification draws on
- IEC 62353:2014 Defines the recurrent and after-repair test methods (protective earth, insulation, equipment and applied-part leakage by direct, differential and alternative methods) and limits the analyser must perform.
- IEC 60601-1:2005+AMD1:2012+AMD2:2020 Defines the type-test methods the analyser reproduces: protective earth (clause 8.6), leakage currents with the measuring device network under normal and single fault conditions (8.7) and insulation (8.8).
- IEC 61010-1:2010+AMD1:2016 Basic electrical safety standard for measuring and laboratory equipment; the analyser itself must meet it.
- IEC 61010-2-030 Particular safety requirements for equipment with testing and measuring circuits, such as the analyser's measuring inputs and leads.
- IEC 61326-1:2020 EMC requirements for electrical equipment for measurement, control and laboratory use.
- IEC 60990:2016 Methods of measuring touch current and protective conductor current; source of the measuring networks used for enclosure and IEC 61010-1 leakage tests.
- ISO/IEC 17025:2017 Requirements for testing and calibration laboratories; governs the analyser's calibration certificate and the testing lab's own accreditation.
- NFPA 99:2024 US Health Care Facilities Code; its electrical equipment testing limits are offered as preset sequences in many analysers and used by some private hospitals.
- 21 CFR Part 11 US FDA rule on electronic records and signatures; used as the benchmark for audit trails and user controls in test-records software.
- IEC 61557-16 Performance requirements for test instruments used to check the protective measures of medical electrical equipment to IEC 62353; ask the bidder to state conformity.
Common mistakes in tenders for this equipment
- Copying one analyser's datasheet (an exact number of patient posts, a specific record count, a named software or a fixed 25 A test) so only one brand complies; state minimum needs with 'not less than' and justify any advanced item.
- Asking for DRAP medical-device registration, ISO 13485 or IEC 60601-1 certification of the analyser itself; it is IEC 61010-1 test equipment, so these demands only confuse bidders or exclude genuine makers.
- Assuming a portable analyser performs a full IEC 60601-1 type test: it does not do the dielectric strength (hipot) test and most do not supply the device at 110% voltage; tender bench instruments as a separate lot.
- Accepting a 200 mA protective earth test for a testing lab or factory when IEC 60601-1 type and production tests need 25 A, or demanding 25 A from a hospital that only needs IEC 62353.
- Leaving out ECG lead adaptors, plug adaptors for BS 1363, BS 546 and CEE 7 plugs and a verification box, so the analyser cannot be connected to real devices or checked between calibrations.
- Not asking for an ISO/IEC 17025 accredited calibration certificate and a loan unit; calibration is often done abroad and the lab can be without its analyser for weeks every year.
- Ignoring software licence terms: records software may be a yearly subscription or limited to one PC; ask bidders to price licences and updates for 5 years.
- Running acceptance tests from a UPS, generator or isolation transformer without an earthed neutral, which gives falsely low leakage readings and passes unsafe devices.