What is IEC 60601 Certification?

Medical Electrical Equipment. Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems (IEC 60601-2-47:2001).

Achieving EN 60601 and CE Marking for Market Access in Europe 

EN 60601 is a standard for medical electrical equipment. Manufacturers aiming to introduce medical electrical equipment into the European market must affix the CE marking to their devices, indicating compliance with applicable European Medical Device Directives.

The Medical Device Directive includes essential requirements that must be met by conforming to harmonized standards. This is the preferred method of demonstrating compliance, as it provides a "presumption of conformity." This approach helps all manufacturers of medical electrical equipment to meet the essential requirements of EN 60601.

What is the EN 60601 Standard? 

EN 60601 is a series of standards covering the safety, essential performance, and electromagnetic compatibility of medical electrical equipment and systems. It is technically equivalent to the international standard IEC 60601, comprising over 70 individual standards.

The "Part 1" standard, EN 60601-1, addresses the general safety and essential performance of all medical electrical equipment. In contrast, "Part 2" or "specific" standards outline requirements for particular product groups (e.g., EN 60601-2-22 for medical lasers).

Compliance with EN 60601-1 Standard 

EN 60601-1 applies to all medical electrical equipment and medical electrical systems. Medical electrical equipment is defined by the standard as having electrical components applied to the patient or transferring energy to or from the patient. Its functions include:

1. Connecting to a specific power source.

2. Being intended by the manufacturer for use in:

   - Diagnosing, treating, or monitoring a patient.

   - Compensating for or alleviating disease, injury, or disability.

This includes various medical devices, such as: 

1. High-frequency surgical equipment 

2. Defibrillators 

3. Patient monitors 

4. Therapeutic and diagnostic ultrasound equipment 

5. Medical lasers 

6. Patient ventilators 

7. Infant incubators and warmers 

Demonstrating compliance with EN 60601-1 requires detailed knowledge of its requirements and specialized test equipment. For information on the latest updates to the standard, refer to the position statement on the third edition of EN 60601-1. These updates include the introduction of extensive risk management requirements.

Why Choose Us for Medical Device EN 60601 Compliance? 

1. We have over 30 years of experience testing to EN 60601-1 requirements. 

2. Our laboratories are members of the CB Scheme, which globally recognizes test reports and certificates. 

3. We offer pre-testing reviews and assist in developing test plans, including risk management expectations. 

4. Our regulatory experts are product specialists with years of experience in designing and testing various devices.