IEC 62353, IEC 60601 and VDE 0751

IEC 62353, IEC 60601 and VDE 0751 compared (AI-generated image)

Functional Testing in Accordance with IEC 62353

IEC 62353 describes the procedures for recurrent testing and testing after repair of medical electrical equipment. In addition to electrical safety measurements, testing includes a functional check to verify that the medical device operates correctly for its intended use. This ensures that both the electrical safety and the basic functionality of the device are maintained.

Important Note

IEC 62353 exclusively governs electrical safety testing procedures after repair and during recurrent testing. Device-specific performance and functional tests are supplemented by the relevant IEC 60601-2-xx standards, the manufacturer's instructions and national legal requirements.

IEC 60601 and IEC 62353 Compared

The key difference between IEC 60601 and IEC 62353 lies in when they apply and their focus within the lifecycle of a medical device.

IEC 60601: The Core Standard for Manufacturers

IEC 60601 is the international core standard that defines the basic safety and performance requirements for medical electrical equipment.

Scope: It is primarily applied during development and manufacturing, as well as for type testing and general verification of safety.
Target users: It is the principal standard for manufacturers and qualified service companies.
Content: It ensures that only tested and safe equipment is placed on the market by requiring comprehensive safety testing in accordance with the relevant product standard.

IEC 62353: The Standard for Equipment in Use

IEC 62353 applies once a device has been put into service and is the standard for safety during ongoing operation.

Scope: It defines the framework for regular recurrent testing and testing after repair.
Target users: It is tailored to the needs of operators, such as hospitals and clinics, biomedical engineering departments and service organisations.
Content: The standard describes practical testing procedures that can be carried out quickly and reliably in the often busy clinical environment. Its specific focus is electrical safety during the device's service life.

IEC 60601, IEC 62353 and VDE 0751 Compared

Characteristic	IEC 60601	IEC 62353	VDE 0751 (DIN EN 62353 / VDE 0751-1)
Main Purpose	Defining basic safety and performance requirements (What requirements must the device meet?)	Defining testing procedures for medical devices in use (How is testing carried out?)	German adoption of IEC 62353 for testing during operation and after repair
When It Applies	Development, design, production, type testing	Recurrent testing, testing after repair, commissioning (where required)	Recurrent testing, testing after repair, safety assessment during operation
Primary Users	Manufacturers, development and testing laboratories	Operators, service technicians, biomedical technicians	Operators, biomedical technicians, service technicians, qualified persons under the MPBetreibV
Focus	Comprehensive safety and performance testing in accordance with the product standard, including EMC and essential performance	Practical electrical safety testing using simplified measurement methods for equipment in use	Electrical safety testing of medical devices in everyday clinical use in accordance with German requirements
Typical Tests	Type testing, leakage currents, insulation testing, temperature rise, EMC, mechanical safety, risk assessment	Visual inspection, protective earth resistance, insulation resistance, leakage current measurements using the alternative, differential or direct method, functional testing	Visual inspection, protective earth resistance, insulation resistance, leakage current measurements, functional testing and documentation
Scope	Development and approval of medical devices	Medical devices in use	Medical devices in use in Germany
Outcome	Evidence of conformity for CE marking	Evidence of electrical safety during operation	Documented clearance for continued safe operation

The Standards at a Glance

IEC 60601 answers the question: “How must a medical device be designed?”
IEC 62353 answers the question: “How is the electrical safety of a medical device tested during operation?”
VDE 0751 is the German edition of IEC 62353 and describes the same testing procedures within the national context. It is the commonly used reference in Germany for recurrent testing and testing after repair in accordance with the requirements for operating medical devices.

In practice, both standards are often used together: while IEC 60601 ensures that the device is designed safely, IEC 62353 ensures through regular inspections that this safe condition is maintained throughout its service life. Modern test instruments often perform automated sequences for both standards to enable comprehensive documentation.

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