EMC China Lab

What is IEC 60601 Certification?

Views :
Update time : 2024-12-29

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

What is IEC 60601 Certification?(图1)

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.


Email:hello@jjrlab.com


Leave Your Message


Write your message here and send it to us


Related News
Read More >>
Electrical Product Certification in Australia Electrical Product Certification in Australia
07 .31.2025
Electrical certification in Australia ensures safety to AS/NZS 60335, 60598, 60950. JJR Testing Labo...
Restriction of Hazardous Substances RoHS Directive Restriction of Hazardous Substances RoHS Directive
07 .31.2025
RoHS restricts hazardous substances in electronics per EU law. JJR Lab provides testing to ensure co...
EU Authorized Representative for Medical Devices EU Authorized Representative for Medical Devices
07 .31.2025
JJR LAB offers EU Authorized Rep services to ensure MDR compliance, product registration, and full r...
CE Testing for Wooden Toys CE Testing for Wooden Toys
07 .31.2025
CE testing ensures wooden toys meet EU standards EN71-1/2/3. JJR Lab offers reliable testing and cer...
CE Testing for Soft Toys CE Testing for Soft Toys
07 .31.2025
CE testing for soft toys ensures EU safety compliance. JJR Lab offers full EN71 testing and certific...
CE Testing for Handmade Toys CE Testing for Handmade Toys
07 .31.2025
Handmade toys require CE testing per EN 71 & EN 62115 standards. JJR Laboratory provides expert ...
CE Testing for Crochet Toys CE Testing for Crochet Toys
07 .31.2025
JJR Lab offers comprehensive CE testing for crochet toys to meet EU EN71 safety standards, ensuring ...
CE Authorised Representative Services CE Authorised Representative Services
07 .31.2025
JJR Lab offers EU Authorised Representative services to ensure CE compliance, product traceability, ...

Leave Your Message