QCentric Certifications Private Limited

Medical Electrical Safety Testing

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Medical Device Testing Laboratory
combined Electrical Safety
Medical Electrical Equipment

Comprehensive electrical safety testing for active medical devices in accordance with IEC 60601-1 requirements.

Active medical devices must demonstrate electrical safety and essential performance to meet regulatory and market approval requirements. QCentric provides independent medical electrical testing services for active medical devices in compliance with IEC 60601-1, ensuring patient safety, operator protection, and regulatory acceptance.

Our testing approach focuses on accuracy, repeatability, and clear documentation to support conformity assessment and certification.

Standard Covered

IEC 60601-1 – Medical Electrical Equipment
General requirements for basic safety and essential performance.

Scope of Testing

We perform comprehensive electrical safety evaluations, including but not limited to:

  • Earth bond testing
  • Leakage current measurements
  • Earth leakage current
  • Enclosure leakage current
  • Applied part / patient leakage current (Normal Condition)
  • Patient leakage current (Single Fault Condition – Supply Open)
  • Patient leakage current (Single Fault Condition – Earth Open)
  • Patient leakage current (F-Type)
  • Patient auxiliary current testing
  • Single fault condition – supply open
  • Single fault condition – earth open

Additional IEC 60601-1 test requirements are covered based on device configuration and risk classification.

Testing Capabilities

Our implant testing capabilities are structured to assess both static and dynamic performance characteristics, including:

  • Static bending, compression, and torsional testing
  • Fatigue and endurance testing under cyclic loading
  • Pull-out strength and fixation stability testing
  • Disassembly and modular interface evaluation
  • Functional performance and load-bearing assessment

All testing is conducted using validated test setups, calibrated equipment, and controlled laboratory conditions.

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QCentric Certifications Private Limited

Ensure Medical safety compliance?

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Q-Centric

QCentric Certifications Private Limited is built on the principle that medical device testing demands diligence, competence, and accountability. We perform independent testing and assessments to support safety, performance, and regulatory compliance across the medical device lifecycle.

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Contact

2nd Floor, SCO 9, DLF Valley Bazaar, Chandi Mandir, Panchkula, Haryana – 134107, India

Call: +91-8076880013
Email: [email protected]

Partner with QCentric for compliant, credible, and competent testing solutions.

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