How to Get the EN 60601-1 Test Report?

EN 60601-1 applies to all medical electrical equipment and medical electrical systems. Many public health authorities recognize IEC 60601-1:2005 as a prerequisite for the commercialization of electrical equipment used in medical devices. Specific safety and essential performance requirements for dynamic ECG systems are included in IEC 60601-2-47:2001.

Obtaining EN 60601 and CE certification for European Market Access

For medical electrical equipment and devices, manufacturers who want to introduce their products into the European market must obtain the CE marking to demonstrate compliance with the applicable European Medical Device Directives.

The Medical Device Directive contains essential requirements that must comply with harmonized standards, as this provides a "presumption of conformity," ensuring that all manufacturers meet the EN 60601 basic requirements.

What is the EN 60601 Standard?

EN 60601 is a series of standards encompassing the safety, essential performance, and electromagnetic compatibility of medical electrical equipment and systems. Technically equivalent to the international standard IEC 60601, this series includes over 70 individual standards.

The "Part 1" standard of EN 60601-1 covers the general safety and essential performance of all medical electrical devices, while "Part 2" or "Particular" standards address requirements for specific product groups (e.g., EN 60601-2-22 for medical lasers).

Main Sections of the IEC 60601 Medical Equipment Standard:

1. IEC 60601-1: General safety requirements for medical electrical equipment.

2. IEC 60601-1-1: General safety requirements and Amendment No. 1.

3. IEC 60601-2-1: Specific safety requirements for gamma-beam therapy devices.

4. IEC 60601-1-2: General safety requirements, Section 1.2 parallel standards for electromagnetic compatibility requirements and testing.

Compliance with EN 60601-1 Standards

EN 60601-1 applies to all medical electrical equipment and systems. Medical electrical equipment, as defined, involves an application part or transfers energy to or from a patient, with functions intended by the manufacturer for:

1. Connection to more than one power source.

2. Use in patient diagnosis, treatment, or monitoring, or for alleviating illness, injury, or disability.

Examples of such medical devices include:

1. High-frequency surgical devices

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 requirements and specialized testing equipment.

Documentation Needed for IEC 60601 Compliance:

1. Circuit schematics & PCB layout

2. Product manual and label

3. Product operation diagram and block diagram

4. List of critical components (wiring, plugs, fuses, varistors, optocouplers, X/Y capacitors, transformers, housing, etc.)

5. Product BOM (Bill of Materials)

6. Product-related specifications

Testing Process for IEC 60601 Standard Compliance:

1. Complete the IEC 60601 Standard Test Certificate application in English.

2. Clearly specify the application date.

3. If the applicant and manufacturer are the same, fill in the same name and address in each respective field.

4. For components already certified to the IEC 60601 standard, include the component name and CB certificate number, if available.

5. Authorized representative's signature.

Processing Time and Costs for IEC 60601 Certification

Testing duration depends on the specific product, and costs vary based on the project. China JJR Laboratories provides testing services for IEC EN 60601, ISO 10993, ISO 18562, and other standards. Feel free to consult us! Our test reports are valid for FDA and CE registrations.