Introduction to the Test

It is difficult that the manufacturer gains their certification by domestic regulators before they are marketed.

ICR was recognized by IECEE and KOLAS as CB Testing Laboratory and KOLAS Laboratory. And ICR can issue CB/KOLAS-ILAC Test Report in scope of Medical Electrical Equipment.

Applied field

1. Medical Electrical Equipment:
- CB Test and Report, KOLAS-ILAC Test and Report, CE Test and Report, Performance Test and Report

2. Electrical Equipment for Measurement, Control, and Laboratory use:
- KOLAS Test and Report, CE Test and Report, Performance Inspection and Report

Affected product

General Medical Equipment
Surgical Equipment
Medical Stimulator
Electrosurgical Equipment
Diagnostic X-ray Imaging Device
Diagnostic Device
In-vitro Diagnostic Device
Laboratory Equipment
Measuring Instrument
Control Device

Industry sector

Test Standard

1. Medical Electrical Equipment
IEC/EN 60601-1, IEC/EN 60601-1-3, IEC/EN 60601-1-6, IEC/EN 60601-1-8,
IEC/EN 60601-1-11, IEC/EN 60601-1-12, IEC/EN 60601-2-3, IEC/EN 60601-2-4,
IEC/EN 60601-2-6, IEC/EN 60601-2-10, IEC/EN 60601-2-22, IEC/EN 60601-2-25,
IEC/EN 60601-2-27, IEC/EN 60601-2-28, IEC/EN 60601-2-45, IEC/EN 60601-2-47,
IEC/EN 60601-2-49, IEC/EN 60601-2-54, IEC/EN 60601-2-57, IEC/EN 60601-2-63,
IEC/EN 60601-2-65, IEC/EN 80601-2-30, IEC/EN 80601-2-49, IEC/EN 80601-2-60,
IEC/EN 80601-2-61

2. Electrical Equipment for Measurement, Control, and Laboratory use
IEC/EN 61010-1, IEC/EN 61010-2-010, IEC/EN 61010-2-020, IEC/EN 61010-2-051,
IEC/EN 61010-2-081, IEC/EN 61010-2-101, IEC/EN 61010-2-201

Test Equipment

Equipment in ICR

  • Medical Electrical Equipment Safety Testing Room

  • X-ray Shielded Room

  • Medical Electrical Equipment Mechanical Safety Testing Room

  • Laser Testing Room

Contact Person

Kim young bin

kyb@icrqa.com

KIM KYUNG IN

kikim@icrqa.com