Key Considerations for EN IEC 60601-1 Testing
EN IEC 60601-1, Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance, is a harmonized standard that outlines the essential safety and performance criteria for active medical devices.
Incorporating this standard during the design phase of electrical medical devices is crucial. Additionally, conducting the EN IEC 60601-1 standard test is necessary to verify compliance and demonstrate that the device meets these stringent requirements.
What factors should be considered when conducting EN IEC 60601-1 tests ?
Identification of requirements:
The requirements of EN IEC 60601-1 must be taken into account during the design phase. The main factors affecting these requirements are as follows:
- Device type and intended use
- Energy source
- Applied parts and sterilisation methods (if applicable)
- Working environment (inc. ingress protection)
- Electrical and mechanical properties
- Targeted user population
- Regulatory and regional requirements
- Software and digital specifications
- Risk management
- Life cycle and maintenance
Establishing an overall compliance plan
It should be determined which clauses of the standard should be applied to the device. Effective definition of the device in terms of the criteria mentioned in the previous article will facilitate the creation of the plan. Sometimes it may be necessary to modify the design to meet the requirements of the standard. Therefore, the articles of the standard should be well evaluated during the design phase.
Risk management
A risk management plan in accordance with the ISO 14971 standard must be established. Necessary measures should be taken for risk analysis, assessment and mitigation of risks. The EN 60601-1 standard has a great role in determining risks such as electrical, mechanical, electromagnetic and software. EN 60601-1 is the main standard, which provides a framework for identifying risks. However, different standards that need to be applied depending on the device should also be considered.
Accredited laboratory
The choice of the laboratory where the test will be performed is important. The test report is critical for the validity of the test in many countries. Therefore, IEC 60601-1 Test must be performed in an accredited laboratory.
What are the testing stages in general?
The main issues handled by the standard are as follows:
- General requirements
- Protection against electrical hazards
- Protection against mechanical hazards
- Electromagnetic Compatibility (EMC)
According to the characteristics of the device, the standard also evaluates the following headings:
- Protection against unwanted and excessive radiation hazards
- Protection against excessive temperatures and other hazards
- Accuracy of controls and instruments and protection against hazardous outputs
- Programmable Electrical Medical Systems (PEMS)
- Construction Of ME Equipment
- ME Systems
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Do you have questions about Electrical Safety Testing of Active Medical Devices or medical devices in general? Do not hesitate to contact us via medical@kiwa.com or by filling in the form on this page.
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