Electrical safety and electromagnetic compatibility — IEC 60601 in practice
Every electrical or electronic medical device is subject to the IEC 60601 series, an essential reference framework for obtaining and maintaining CE marking under MDR 2017/745. Yet the interplay between the normative requirements and the documentary expectations of the technical file often remains a point of friction for R&D and testing teams. This two-day training course covers the complete architecture of the standard, from the scope of IEC 60601-1 to the EMC requirements of IEC 60601-1-2, anchoring each module in the operational reality of the engineers who design, test and document electromedical devices.
Audience R&D engineers, test engineers, quality and regulatory affairs managers involved in the design or qualification of active medical devices.
Learning objectives
- ▸ Map the architecture of the IEC 60601 series (general standard, collateral standards, particular standards) and identify the texts applicable to your device
- ▸ Interpret the basic safety and essential performance requirements of IEC 60601-1 (3rd edition, amendments A1 and A2) in order to apply them during the design phase
- ▸ Build an electrical compliance verification strategy incorporating risk management according to ISO 14971
- ▸ Apply the EMC requirements of IEC 60601-1-2 (4th edition): test plans, emission limits, immunity levels, environments of use
- ▸ Link test results to the corresponding sections of the MDR technical file (GSPR, conformity assessment report, verification and validation documentation)
- ▸ Identify the priority checkpoints during a file review by a notified body
Expected outcomes
- ✓ Lead or contribute to the IEC 60601 qualification of an electromedical device and document its compliance within the framework of MDR 2017/745
Accessibility & entry conditions
Access lead time
Registration up to 10 working days before the start of an open-enrolment session. In-house sessions can be scheduled within 3 to 4 weeks.
Prerequisites
General knowledge of the development cycle of a medical device. Prior exposure to electronics or electrical engineering concepts is recommended. No formal regulatory prerequisite.
Disability access
Any disability situation can be accommodated. Contact our officer before registration to explore possible adjustments (equipment, materials, pacing). Contact our officer →
Funding
- ·This training is not Qualiopi-certified and is not eligible for funding via the OPCOs
- ·Funding from own funds or the company's training budget
Detailed programme
A phone interview or positioning questionnaire is sent ahead of the session to calibrate the level, identify expectations and tailor the case studies to participants' real situations.
- 01
Normative architecture and scope (2 h)
- ·IEC 60601 standard family: general standard, collateral standards (IEC 60601-1-2, 1-6, 1-8, 1-11) and particular standards
- ·Criteria for determining applicability to a given device
- ·Interplay with related standards (ISO 14971, IEC 62304, IEC 62366)
- ·Key definitions: applied parts, leakage current, essential performance, basic safety
- 02
Electrical safety requirements: IEC 60601-1 (3rd edition + A1 + A2) (4 h)
- ·Structure of the standard: 17 main clauses
- ·Requirements relating to electrical insulation, leakage currents, mechanical strength, and protection against thermal hazards and radiation
- ·Requirements for programmable electrical medical systems (PEMS)
- ·Impacts of amendments A1 (2012) and A2 (2020)
- ·Practical exercises on excerpts from active medical device specifications
- 03
Electromagnetic compatibility: IEC 60601-1-2 (4th edition) (3 h)
- ·Emission and immunity requirements according to the environment of use (healthcare professional, home healthcare, critical context)
- ·EMC test plans: methodology, choice of accredited laboratory, management of non-conformities
- ·Reading and interpreting EMC test reports
- ·Practical cases on defining the test plan suited to a given piece of equipment
- 04
Integration into the MDR technical file (3 h)
- ·Correspondence between IEC 60601 test results and the general safety and performance requirements (GSPR) of Annex I of MDR 2017/745
- ·Building the verification and validation chapter in the technical file
- ·Risk management (ISO 14971) applied to electrical and EMC risks
- ·Checkpoints during a notified body review
- 05
Synthesis and hands-on scenario (2 h)
- ·Integrative case study: analysis of an incomplete file, identification of gaps and corrective action plan
- ·QCM to validate the knowledge acquired
- ·Questions/answers and lessons learned
Assessment of learning
Assessment methods
QCM of 20 questions administered at the end of the training, covering all modules, supplemented by a practical scenario during module 5 (file analysis). The QCM has a formative purpose: no minimum threshold is required for the issuance of the certificate.
Certificate
Training certificate issued by Isofac Group at the end of the training, subject to full attendance over the two days. This certificate does not constitute a certification recognised under the RNCP or the Specific Directory (RS).
Satisfaction and results
Satisfaction rate: Being measured
First learner survey campaign under way — data published once the statistical threshold is reached.
Training team
Training delivered by the ISOFAC ACADEMY teaching team, made up of consultants specialised in medical devices, quality and regulatory affairs. Depending on the module, the session is led by a specialist with hands-on operational expertise in MDR compliance, ISO 13485 quality management systems, ISO 14971 risk management, clinical evaluation, technical documentation, regulatory audits and CE marking strategy.
Our trainers support manufacturers, distributors, importers, authorised representatives and other economic operators on a daily basis in bringing their medical devices into compliance. See the team's profiles →
Technical resources
In-person
Room equipped at the client site or in a partner centre (Montpellier, Lyon, Paris). Video projector, flipchart, printed materials.
Remote
Zoom (corporate) platform for the virtual classroom. Materials provided in PDF + access to additional resources for 12 months after the session.
Learner equipment
A connected computer with camera and microphone for remote sessions. No software to install.
Post-course follow-up
Advice line
Hotline included for 30 days after the session for operational questions arising back on the job. Reply within 48 working hours.
Follow-up review
3-month review sent to the sponsor for in-house courses: feedback on the skills put into practice and any residual points.
Open-enrolment price (excl. VAT)
1 590 €
EU VAT applicable depending on the buyer's status.
In-house price
On request, depending on headcount and location.
Funding
- ·This training is not Qualiopi-certified and is not eligible for funding via the OPCOs
- ·Funding from own funds or the company's training budget
Personalised quote within 48 hours.
Would you like to attend this course?
Tell us your preferred format (open-enrolment, in-house or virtual classroom), the number of participants and your schedule. We will get back to you within 48 hours with the next available dates and a firm quote.