Introduction to IEC 60601-1 and associated collateral and particulate standards

The IEC/EN 60601 standard covers a wide range of medical electrical equipment, including

• Diagnostic devices: e.g. ECG devices, blood pressure monitors and ultrasound devices.
• Therapeutic devices: e.g. infusion pumps and laser therapy devices.
• Monitoring devices: e.g. patient monitoring monitors and vital sign monitors.
• Medical laboratory equipment: e.g. blood analyzers and centrifuges.
• Surgical instruments: e.g. electrosurgical units and surgical lasers.

Important aspects of the IEC/EN 60601 standard

The IEC 60601-1 standard specifies requirements for basic safety and the essential performance characteristics for the following areas, for example:

Electrical safety: Requirements for insulation systems, leakage currents and protection against electric shock. (IEC 60601-1)

Mechanical safety: Strength requirements for enclosures, moving parts and mechanical stability. (IEC 60601-1)

Thermal safety: Requirements for surface temperatures and thermal protection measures. (IEC 60601-1)

Electromagnetic compatibility (EMC): Requirements for minimizing electromagnetic interference and ensuring proper functioning in electromagnetic environments. (IEC 60601-1-2)

Ergonomics and usability: Guidelines for designing user-friendly and safe interfaces. (IEC 60601-1-6)

Sub-standards of IEC/EN 60601

In addition to the general IEC/EN 60601-1 standard, which defines general electrical safety requirements for medical devices, there are specific sub-standards that define additional requirements for certain types of medical devices.

The “sub-standards” are called

• Collateral standard => 60601-1-x
• Particulate standards => 60601-2-x

These sub-standards include:

• EN/IEC 60601-2-4: Requirements for defibrillators, which specifically cover the safety and performance requirements for cardiac defibrillation devices.
• EN/IEC 60601-2-18: Requirements for endoscopes and endoscopic accessories that ensure the safety and performance of devices used in minimally invasive procedures.
• EN/IEC 60601-2-25: Requirements for electrocardiographs (ECG devices) that ensure accurate recording of the electrical activity of the heart.
• EN/IEC 80601-2-30: Requirements for automated non-invasive blood pressure monitors that ensure the accuracy and reliability of blood pressure monitoring devices.
• EN/IEC 60601-2-35: Requirements for heating devices for therapy and diagnostics covering the safety and performance standards for devices for the thermal treatment of patients.

• EN/IEC 60601-2-66: Requirements for hearing aids that ensure the safety and effectiveness of hearing support devices.

Services from cetecom advanced
for IEC/EN 60601 and its sub-standards

At cetecom advanced, we offer comprehensive services to test and certify your medical electrical devices according to IEC/EN 60601 and its sub-standards with our partner network

Our experienced team supports you in all phases of the development process and ensures that your products meet the required safety and performance standards.

Our services include:

• Support in the interpretation of IEC/EN 60601 and the specific sub-standards as well as training for your employees.
• Preliminary testing and risk assessment:: Carrying out risk analyses and preliminary tests to identify potential weak points at an early stage.
• Testing and certification: Carrying out electrical, mechanical, thermal and EMC tests in accordance with the requirements of the IEC/EN 60601 standard and its sub-standards.
• Documentation review: Support in the creation and review of technical documentation to ensure that all requirements are met.
• Ongoing support: Ongoing support and advice throughout the lifecycle of your product, including retesting and recertification.

Electrical safety tests for medical devices:

• EN/IEC 60601-1: Infusomats/Perfusor, ergometers, ultrasound (with tested sensors), surgical monitors, audiometers, ophthalmic lens measuring devices, blood glucose meters, blood transfusion devices, light therapy, cryotherapy and stimulation current devices
• EN/IEC 60601-1 / -1-8 (alarm systems) / -1-11 (domestic environment) / -1-12 (emergency use) and EN/IEC 60601-2-66 including testing for compliance with the required technical documentation such as risk management (ISO 14791), suitability for use (EN/IEC 60601-1-6 + IEC 62366-1), software documentation (EN 62304)EN/IEC
• EN/IEC 60601-1 + EN/IEC60601-2-4: Defibrillators
• EN/IEC 60601-1 + EN/IEC60601-2-18: Colonoscopes and endoscopes
• EN/IEC 60601-1 + EN/IEC60601-2-25: Electrocardiographs
• EN/IEC 60601-1 + EN/IEC80601-2-30: Blood pressure monitors
• EN/IEC 60601-1 + EN/IEC60601-2-35: Electric blankets
• EN/IEC 60601-1 + EN/IEC60601-2-66: Hearing aids
• EN/IEC 61010-1: Safety requirements for electrical equipment for measurement, control and laboratory use
• EN/IEC 61010-031: Hand-held measuring accessories for electrical measurement and testing
• EN/IEC 61010-2-040 (disinfection) / -081 (automatic and semi-automatic laboratory equipment) / -101 (in-vitro diagnostics (IVD))

EMC tests for medical devices:

• EN/IEC 60601-1-2: Electromagnetic disturbances
• EN/IEC 60118-13: Electroacoustics – Hearing aids
• EN/IEC 61326-2-6: In vitro diagnostic medical devices (IVD)

Why cetecom advanced?

• Experience and expertise: Decades of experience in the testing and certification of medical devices.
• State-of-the-art testing facilities: State-of-the-art laboratories and testing facilities for comprehensive and precise testing.
• Customer-centric approach: Individual solutions tailored to your specific needs.
• Global reach: Market approval support in various regions and countries worldwide.

Get in touch with us

For more information about our services in the field of IEC/EN 60601 and its sub-standards or to arrange a meeting, please contact us at mail@cetecomadvanced.com.

Let’s work together to ensure that your medical electrical equipment meets the highest safety and performance standards.