Medical Electrical Equipment Testing-Inspection Service-Services-Xuchang KETOP Testing Research Institute Co., Ltd.

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Medical Electrical Equipment Testing

KETOP provides testing services for active medical electrical equipment and can issue formal test reports for Electromagnetic Compatibility (EMC), software, and climatic environmental testing. Additionally, KETOP possesses general safety testing capabilities.

Applicable Product Types

■ Therapeutic Equipment

Defibrillator, Ventilator, Infusion Pump, Physiotherapy Apparatus

■ Monitoring Equipment

Electrocardiograph, Ultrasound Device, Glucometer, Sphygmomanometer

■ Diagnostic Equipment

X-Ray Machine, Ultrasound Diagnostic Apparatus, Cell Analyzer

■ Auxiliary Equipment

Surgical Lamp, Medical Oxygen Generator, Patient Monitor, Anesthesia Machine

■ Laboratory Equipment

Mass Spectrometer, Physiological Recorder, Pharmacological Experiment Instrument, Fully Automated Sample Processing System

Testing Capabilities

Protocol Tests

We can conduct software quality characteristic testing

Environmental Tests

Capable of conducting climatic environmental tests and mechanical environmental tests on various types of medical electrical equipment.

Electromagnetic Compatibility (EMC) Tests

EMC testing for all types of Medical Electrical Equipments,with the exception of ME equipment and ME systems other than those intended for life support, ME equipment and ME systems that incorporate radio frequency electromagnetic energy receivers, and ME equipment or ME systems of type A applied parts.

Testing Capability Scope

Protocol Tests

GB/T 25000.51-2016(ISO/IEC 25051-2014) Systems and software engineering-Systems and software Quality Requirements and Evaluation (SQuaRE)-Part 51: Requirements for quality of Ready to Use Software Product (RUSP) and instructions for testing

Environmental Tests

GB/T 14710-2009 Environmental requirement and test methods for medical electrical equipment

IEC 60601-1:2012/GB 9760.1-2020 Medical electrical equipment-Part 1:General requirements for basie safety and essential performance

Electromagnetic Compatibility (EMC) Tests

YY 9706.102-2021 / IEC 60601-1-2:2014 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic compatibility - Requirements and tests

GB/T 18268.1-2010 - Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements

GB/T GB/T 18268.26-2010 - Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 26: Particular requirements - In vitro diagnostic (IVD) medical equipment

GB/T 17626 Electromagnetic Compatibility (EMC) - Testing and Measurement Techniques Series

Business Inquiries

Contact

Xinmei Chen

Telephone

0756-3869069

chenxinmei@ketop.cn

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