EN 60601 – Medical Electrical Equipment is the universally recognized technical standard series for the safety and effectiveness of medical electrical equipment. Compliance with EN 60601 is practically mandatory for demonstrating conformity with the EU Medical Device Regulation (MDR) and placing devices on the global market.
What Is EN 60601?
EN 60601 is a series of technical standards that cover the safety and essential performance of Medical Electrical (ME) Equipment and ME Systems. It applies to any device that has an applied part (contacts the patient), transfers energy to/from the patient, or detects such energy transfer.
The standard is unique because it is not a single document, but a hierarchy of three layers:
1. General Standard
(EN 60601-1)
The Parent Standard: Defines general requirements for basic safety and essential performance applicable to all medical electrical equipment.
2. Collateral Standards
(EN 60601-1-XX)
Horizontal Topics: Requirements that apply to subgroups of equipment (e.g., EMC, Usability, Alarm Systems, Home Healthcare).
3. Particular Standards
(EN 60601-2-XX)
Device Specific: Modifications to the general standard for specific device types (e.g., MRI scanners, infusion pumps, HF surgical equipment).
Core Concepts: Safety & Performance
EN 60601 goes beyond simple electrical safety. It requires manufacturers to identify hazards and ensure that risks are acceptable under both Normal Condition (NC) and Single Fault Condition (SFC).
| Hazard Category | Focus Area |
|---|---|
| Electrical Hazards | Leakage currents, dielectric strength, grounding reliability, patient protection (MOPP). |
| Mechanical Hazards | Crushing, trapping zones, instability, transportability, suspended masses. |
| Thermal & Fire | Temperature of applied parts, fire prevention in oxygen-rich environments. |
| Essential Performance | Clinical functions whose failure would result in unacceptable risk (e.g., incorrect drug delivery). |
Who Needs EN 60601 Compliance?
Compliance is required for manufacturers, importers, and authorized representatives dealing with:
🏥 Therapeutic Devices: Defibrillators, ventilators, incubators, surgical lasers.
🩺 Diagnostic Equipment: ECG, EEG, Ultrasound, MRI, CT Scanners.
🏠 Home Healthcare: Patient lifts, oxygen concentrators, nebulizers.
📟 Monitoring Systems: Multi-parameter patient monitors, pulse oximeters.
How to Achieve EN 60601 Certification
- Identify Standards: Determine if a “Particular Standard” (Part 2-XX) exists for your specific device type. This takes precedence over the General Standard.
- Purchase Official Documents: Acquire official copies of the standards to ensure you are designing to the correct legal revision.
- Risk Management (ISO 14971): Create a Risk Management File. EN 60601-1 explicitly requires compliance with ISO 14971.
- Design & Development: Implement requirements for isolation diagrams, creepage/clearance distances, and component selection.
- Type Testing: Send the device to an accredited testing laboratory (e.g., ILAC accredited) for verification.
- Technical File: Include the CB Test Report and certificates in your Technical File for CE Marking submission.
📥 Access Official EN 60601 Standards
Ensure your medical device meets EU MDR requirements. Download the official General, Collateral, and Particular standards from Genorma.
⚠️ Official PDF Standards starting from €250.00
Available in PDF and Hardcopy formats.
Frequently Asked Questions
Is EN 60601 mandatory for CE Marking?
Technically, standards are voluntary, but EN 60601 is the “Harmonized Standard” for medical electrical equipment. Complying with it is the only practical way to demonstrate a “Presumption of Conformity” with the General Safety and Performance Requirements (GSPR) of the EU MDR.
What is the relationship between EN 60601 and ISO 14971?
They are inseparable. EN 60601-1 Clause 4.2 explicitly requires a risk management process compliant with ISO 14971. You cannot pass a 60601 audit without a complete Risk Management File.
What is a “Particular Standard” (Part 2)?
A Particular Standard (e.g., EN 60601-2-24 for infusion pumps) modifies the General Standard. If a Part 2 exists for your device, its requirements override the General Standard requirements.
Do I need to buy the official standard?
Yes. Testing laboratories and Notified Bodies require you to hold licensed copies of the specific standards applied to your device to validate your Declaration of Conformity.