Medical Electrical Safety Checks: When to Request a NEN-IEC 62353 Inspection
Medical electrical equipment must work safely every time it is used. When devices are moved, maintained, or used over long periods, hidden defects can develop and safety risks can increase. A NEN-IEC 62353 inspection helps verify that medical electrical equipment remains safe to use throughout its service life.
For organisations that rely on medical devices, knowing when to request a NEN-IEC 62353 inspection is just as important as knowing what the inspection includes. This guide explains what the inspection is, when it should be scheduled, what is checked, and how to prepare.
What is a NEN-IEC 62353 inspection?
A NEN-IEC 62353 inspection is a safety assessment for medical electrical equipment. Its purpose is to ensure that medical electrical devices continue to operate safely during use, including after maintenance or transport.
In practical terms, this inspection focuses on the electrical safety of medical devices. It is designed to help identify hidden defects, reduce the risk of electrical shock, and support safe operation for both patients and healthcare professionals.
Short definition
NEN-IEC 62353 is a standard used for the periodic testing and inspection of medical electrical equipment to confirm continued safe operation.
When should you request a NEN-IEC 62353 inspection?
A NEN-IEC 62353 inspection is particularly relevant when medical electrical equipment must be shown to remain safe over time. In many environments, waiting until a problem becomes visible is too late. Safety issues may exist even when a device appears to function normally.
You should consider requesting a NEN-IEC 62353 inspection in the following situations:
1. During periodic safety checks
Medical electrical devices should be checked periodically to confirm that they still meet safety expectations during their operational life.
This is especially important where equipment is used frequently or where safety is mission-critical.
2. After maintenance or repair
After a device has been serviced, its safe electrical operation should be verified. Maintenance can affect connections, insulation, or protective measures, which is why post-maintenance inspection matters.
3. After transport or relocation
Transport damage is not always visible. If equipment has been moved between rooms, departments, buildings, or sites, a NEN-IEC 62353 inspection can help determine whether the device remains safe to use.
4. When there is concern about hidden defects
Some electrical faults are not obvious during normal operation. If there is any doubt about the condition of a device, a professional inspection can help uncover issues before they create risks.
5. As part of a broader maintenance and inspection plan
A structured inspection approach supports compliance, traceability, and safer long-term equipment management. If your organisation works with a formal maintenance schedule, NEN-IEC 62353 can form an important part of that process.
What is checked during a NEN-IEC 62353 inspection?
A NEN-IEC 62353 inspection includes a combination of visual checks, measurements, and functional testing.
Wassenaar Inspecties carries out tests such as:
- Leakage current measurements
- Insulation resistance tests
- Functional checks
- Visual inspections
Detailed documentation of the inspection is also provided.
Visual inspection
The visual inspection checks whether:
- Required drawings are present and contain correct information
- Different parts are clearly identifiable
- Any visible damage presents a safety risk
- Electrical materials meet installation requirements
- Connections of visible protective conductors are in good condition
- Correct protective equipment is present and properly set
- Signs of ageing or wear could affect safety
Measurements and testing
During measurements and tests, the inspection checks compliance related to:
- Protective conductors and their connections
- Insulation resistance of each part of the equipment
- Correct operation of residual current devices
- Correct operation of overcurrent protective devices
- Proper functioning of control and protective equipment
- Safety of equipment and tools used during operation
Additional points of attention
The inspection also considers:
- The general condition of the medical electrical equipment
- The environment in which the equipment is located
- Whether suitable safety instructions and markings are present
- Whether an adequate maintenance and inspection plan has been implemented
Why these medical electrical safety checks matter
Medical environments demand a higher level of care because equipment performance can directly affect treatment and patient safety. Electrical faults in such settings may create risks not only for users, but also for patients connected to or dependent on the device.
A NEN-IEC 62353 inspection supports safer use by helping organisations:
- Detect hidden defects
- Reduce the chance of electrical shock
- Confirm safe operation after maintenance or transport
- Maintain clear inspection records
- Strengthen confidence in the condition of medical electrical equipment
In many organisations, documented electrical safety checks also make internal oversight easier. When inspection reports are clear and consistent, decision-makers can prioritise repairs, retesting, or replacement more effectively.
NEN-IEC 62353 vs NEN 3140: what is the difference?
This question often comes up, especially in organisations that already schedule inspections for general electrical safety.
Direct answer
A NEN-IEC 62353 inspection is focused on the electrical safety of medical devices.
A NEN 3140 inspection focuses on the safety of low-voltage electrical installations and work equipment in buildings to reduce general workplace risks.
Why the distinction matters
These inspections do not serve the same purpose. If you use medical electrical devices, a general workplace electrical inspection does not replace a device-specific medical electrical safety assessment.
That is why it is important to choose the inspection type that matches the equipment and risk profile involved. Organisations that manage both building installations and medical equipment may need multiple inspection categories as part of a complete safety strategy.
How to prepare for a NEN-IEC 62353 inspection
Good preparation makes the inspection process smoother and more efficient.
Practical preparation steps
Before the inspection:
- Make sure all equipment is accessible for inspection
- Document previous inspections and maintenance work
- Check that electrical parts are in good condition
- Review your maintenance and inspection records
If your organisation uses multiple locations, it can also help to organise equipment lists by site or department in advance.
What happens if equipment does not pass?
If equipment does not meet the required standard, the inspector prepares a report describing the identified defects and recommendations for improvement.
After that, the organisation has the opportunity to make the necessary adjustments and request a re-inspection.
Wassenaar Inspecties provides:
- A detailed report with identified defects
- Advice on the steps needed for improvement
- Guidance with the implementation of required adjustments
This approach helps organisations move from detection to corrective action in a structured way.
Why choose a certified inspection partner?
For medical electrical safety, expertise matters. A NEN-IEC 62353 inspection should be carried out by a party with the right certification and technical competence.
Wassenaar Inspecties states that it is officially certified for NEN-IEC 62353 inspections and performs these inspections using extensive testing and clear documentation.
Its inspectors assess medical electrical equipment according to detailed protocols and technical specifications to verify compliance with legal and technical requirements.
Practical takeaways: when to schedule your inspection
If you want a simple rule of thumb, request a NEN-IEC 62353 inspection when medical electrical equipment:
- Is due for a periodic safety check
- Has undergone maintenance or repair
- Has been transported or relocated
- Shows signs of possible wear, damage, or hidden defects
- Needs to be included in a documented maintenance and inspection plan
Quick checklist
Use this checklist to decide whether it is time to act:
- Is the equipment medical and electrically powered?
- Has it been serviced recently?
- Has it been moved or transported?
- Do you need proof of continued safe operation?
- Do you want documented inspection results?
If the answer to one or more of these questions is yes, a NEN-IEC 62353 inspection may be the right next step.
Service and support
Wassenaar Inspecties is open Monday to Friday, from 09:00-17:00 and is available to help with questions about its services and to guide clients through the inspection process.
For organisations planning inspections across multiple locations, Wassenaar Inspecties also has branches in:
- Breda — Schapenweide 1, 4824 AN Breda
- Amsterdam — Keizersgracht 482, 1017 EG Amsterdam
- Bergen op Zoom — Zuidzuidehaven 39 A, 4611 HC Bergen op Zoom
- Eindhoven — Hurksestraat 64, 5652 AL Eindhoven
- Leeuwarden — Lange Marktstraat 1, 8911 AD Leeuwarden
- Den Haag — Platinaweg 25, 2544 EZ Den Haag
- Enschede — Wethouder Beversstraat 185, 7543 BK Enschede
- Groningen — Leonard Springerlaan 35, 9727 KB Groningen
- Rotterdam — Corkstraat 46, 3074 AC Rotterdam
Related inspection topics to explore
If your organisation is reviewing electrical safety more broadly, it can also be useful to compare medical equipment checks with other inspection categories, such as:
- NEN 3140 for general low-voltage electrical safety in buildings and work equipment
- Other electrical inspection services relevant to installations and business assets
This helps create a more complete view of how device safety and installation safety fit together.
Conclusion
A NEN-IEC 62353 inspection is the right choice when you need to verify the ongoing electrical safety of medical electrical equipment, especially during periodic checks and after maintenance or transport. It combines visual inspection, leakage current measurements, insulation resistance testing, and functional checks to confirm that equipment remains safe to use.
For organisations that depend on reliable medical devices, timely inspection is a practical way to reduce risk, identify hidden defects, and maintain clear documentation.
If you want expert guidance on when to request a NEN-IEC 62353 inspection or you are ready to schedule one, contact Wassenaar Inspecties to discuss your equipment, inspection needs, and next steps.