Electrical Safety Testing/IEC 60601 Series

Accurately Evaluate Electrical Safety to Ensure Medical Safety

Pre-consulting Services for IEC 60601 Standards.
Regulatory support team standby for compliance and market access.
Customized electrical safety testing plans.
One-stop medical device analysis services including other related analysis projects.
Continuous improvement based on industry feedback.
Rigorous quality control system.
Professional team.
Advanced laboratory equipment.
Timely response.

Electrical safety testing is a series of tests ensuring that electrical devices, during normal use and possible abnormal conditions, pose no electrical hazards to users and the surroundings. IEC 60601, a widely recognized international standard for the basic safety and performance of medical electrical devices, prescribes relevant safety and performance requirements and is a crucial benchmark for medical device safety. Globally, it has been adapted into "local" standards like UL 60601 - 1 (USA), EN 60601 (EU), and GB 9706.1 (China) in different countries and markets.

AltaNovate can customize electrical safety testing services based on medical device positioning and target markets, precisely matching specific testing standards, along with our professional regulatory support team to help with the registration process. Contact us for any needs.

Fig.2 Workflow of Electrical Safety

Our Service

Electrical safety testing, a core way to assess medical electrical device safety, is vital in judging product compliance. AltaNovate applies the IEC 60601 standard, offering tests like general safety, performance, and electromagnetic compatibility for medical devices to meet specific national safety standards.

Testing Items	Testing Contents	Testing Purpose
Electric Shock Protection Testing	Testing of device insulation, grounding integrity, leakage current, etc., including grounding current resistance test, insulation resistance test, leakage current test, dielectric strength test, etc.	To evaluate the ability of the device to protect users and patients from electric shocks.
Radiation Hazard Protection Testing	Radiation dose detection, radiation protection device effectiveness detection, radiation leakage detection, etc.	To detect whether the radiation dose of medical devices with radiation sources is within safe limits.
Mechanical Hazard Protection Testing	Testing of sharp edges, sharp corners, pinch points, stability, and more.	To examine the housing, structure, moving parts, etc. of the device for possible risks of mechanical injury to the user or patient
Electromagnetic Compatibility (EMC) Testing	Radiated emission test, conducted emission test, anti-interference ability test, field strength measurement, etc.	To ensure the normal operation of medical electrical devices and avoid the harm of internal and external electromagnetic interference.

Need Electrical Safety Testing?

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AltaNovate is your top choice for medical device analysis! We provide one-stop analysis services covering biocompatibility testing, sterility testing, mechanical testing, etc. Regardless of the type of your medical device and the specific testing service it requires, we are capable of offering customized testing solutions. Contact us now for free initial consultations and customized analysis.

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