Postgraduate Diploma in IEC 60601 Conformity (Safety/EMC)
Online 800-hour Postgraduate Diploma in IEC 60601 conformity (Safety/EMC). 8 modules covering IEC 60601-1 (basic safety and essential performance), IEC 60601-1-2 (electromagnetic compatibility) and Fluke Ansur. Dedicated tutor and open enrolment.
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Run a real engineering trade-off from this field. Move the sliders, watch the model react in real time and beat the challenge.
What you will be able to do
Interpret the structure of the IEC 60601 family and its collateral standards.
Design means of protecting the patient and the operator against electrical hazards.
Assess mechanical, thermal and fire risks in electromedical equipment.
Plan electromagnetic compatibility tests in accordance with IEC 60601-1-2.
Apply the requirements for software and medical electrical systems.
Link conformity with risk management in accordance with ISO 14971.
Draft the conformity plan for an electromedical device.
Who it's for
- Regulatory compliance engineer who wants to specialise in IEC 60601 Conformity (Safety/EMC).
- Medical electrical safety engineer who wants to specialise in IEC 60601 Conformity (Safety/EMC).
- EMC engineer who wants to specialise in IEC 60601 Conformity (Safety/EMC).
- Electromedical equipment design engineer who wants to specialise in IEC 60601 Conformity (Safety/EMC).
- Certification laboratory technician who wants to specialise in IEC 60601 Conformity (Safety/EMC).
- Regulatory affairs specialist who wants to specialise in IEC 60601 Conformity (Safety/EMC).
- Engineering or science graduates looking to enter healthcare technology.
What you'll work with
- IEC 60601-1 (basic safety and essential performance)
- IEC 60601-1-2 (electromagnetic compatibility)
- ISO 14971 (risk management for medical devices)
- IEC 62304 (medical device software)
- IEC 60601-1-6 (usability)
- IEC 60601-1-8 (alarm systems)
- IEC 60601-1-11 (home healthcare environment)
8 modules · 800 h
1.1General, collateral and particular standards1.2Edition 3.2 and amendments1.3Essential performance and basic safety1.4Risk management according to ISO 149711.5Equipment classification and applied parts1.6Accompanying documents and marking1.7Relationship with the MDR and harmonised standards1.8CB scheme and TRF reports1.9Planning the certification project1.10Practical: identifying the essential performance of a ventilator
2.1Means of operator and patient protection2.2Basic, double and reinforced insulation2.3Insulation distances and creepage paths2.4Working voltages and categories2.5Leakage currents and limits2.6Dielectric tests2.7Protection against defibrillation2.8Mains connection and power supplies2.9Protective earthing2.10Laboratory: insulation diagram of a device
3.1Stability and moving parts3.2Mechanical strength and drops3.3Temperatures of accessible parts3.4Fire protection3.5Materials and enclosures3.6Liquid spillage3.7IPX water ingress3.8High-integrity components3.9Single fault conditions3.10Practical: analysis of single fault conditions
4.1Edition 4.1 and use environments4.2Conducted and radiated emissions CISPR 114.3Immunity to electrostatic discharges4.4Radiated immunity and proximity fields4.5Fast transients and surges4.6Voltage dips and interruptions4.7Mains-frequency magnetic fields4.8Acceptance criteria and essential performance4.9EMC test plan4.10Workshop: drafting an EMC test plan
5.1IEC 60601-1-6 on usability5.2IEC 60601-1-8 on alarms5.3IEC 60601-1-11 for home use5.4IEC 60601-1-12 for emergency services5.5IEC 60601-1-10 on physiological controllers5.6Radiation requirements IEC 60601-1-35.7Selection of applicable collateral standards5.8Interaction with particular standards5.9Examples of common non-conformities5.10Case study: applicability of collateral standards to a home monitor
6.1Clause 14 on PEMS systems6.2IEC 62304 lifecycle6.3Cybersecurity IEC 81001-5-16.4ME systems under clause 166.5Non-medical equipment in the patient environment6.6IT networks IEC 80001-16.7Updates and change management6.8Software validation6.9Software documentation6.10Practical: software safety classification
7.1Insulation architecture in the design7.2Selection of medical power supplies7.3PCB design for EMC7.4Filtering and shielding7.5Pre-testing in your own laboratory7.6Diagnosis of EMC failures7.7Component supplier management7.8Standards-oriented design reviews7.9Maintaining conformity during changes7.10Case study: correcting a radiated emissions failure
8.1Description of the equipment and intended use8.2Risk analysis8.3Insulation diagram8.4Safety test plan8.5EMC test plan8.6Collateral standards matrix8.7Conformity dossier8.8Action plan8.9Report and presentation8.10Final review with the tutor
How you'll learn
100 % online training on the SEIUM campus, with downloadable material, recorded classes and a dedicated technical tutor. No fixed timetables: students progress at their own pace within the intake, which makes it easy to combine with work.
Each module combines theory, guided reading of the original standard and applied exercises. The working software is Fluke Ansur, LTspice, Ansys Icepak, MATLAB, advanced Excel (traceability matrix), in free, academic or evaluation versions. Tests are studied using real procedures for leakage current and dielectric strength tests, an EMC semi-anechoic chamber and document review of the risk management file. Assessment is continuous per module, plus the final integrating project.
Build it end to end
Your final project follows the real engineering workflow, step by step, reviewed by your tutor.
Interpret the structure of the IEC 60601 family and its collateral standards.
Design means of protecting the patient and the operator against electrical hazards.
Assess mechanical, thermal and fire risks in electromedical equipment.
Plan electromagnetic compatibility tests in accordance with IEC 60601-1-2.
Apply the requirements for software and medical electrical systems.
Where this takes you
Requirements
- Prior technical training or professional experience in the sector. No university degree is required.
- Internet connection and a computer capable of running the programme's software.
- Sufficient level of Spanish to follow technical standards documentation.
Ready to start?
Send your application today. Our admissions team replies within 72 hours with your study plan and funding options.
Frequently asked questions
The programme totals 800 hours, spread over 6 to 8 months. That is between 10 and 15 hours per week on average, compatible with full-time work.
You will work with Fluke Ansur, LTspice, Ansys Icepak, MATLAB, advanced Excel (traceability matrix). Free, academic or evaluation versions are used, and the tutor indicates the free alternative where one exists.
A SEIUM diploma upon passing the continuous assessment and the integrating project. It is in-house training, not an official qualification from the Ministry.
Yes. Modules passed in a course or postgraduate diploma in the same area are credited towards the advanced programme. Check the credit recognition policy when you enrol.
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