TestCert

IEC 60601-1-2 EMC Testing

IEC 60601-1-2 EMC Testing

We provide EMC testing programs for active medical devices and systems, establishing emission and immunity criteria in accordance with IEC 60601-1-2 standards.

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3-4 Weeks
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Accredited testing program
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Scheme testing
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Medical electrical equipment
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We’ve relied on Test Cert for multiple medical device testing projects, and they’ve never disappointed. Their team has deep knowledge of ISO 21530 and other relevant standards. Their timely, well-documented test reports helped us meet both local and international regulatory requirements with ease.”
– Dr. Ayesha Malik, Regulatory Affairs Manager, Meditech Solutions.

List Of Tests

Our IEC 60601-1-2 Testing service helps medical device manufacturers ensure their products meet international standards for electromagnetic compatibility (EMC). We offer comprehensive testing and verification services, including:

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Facilitates global market access for medical devices through mutual recognition of test results.
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Comprehensive testing to ensure medical devices meet electromagnetic compatibility (EMC) requirements.
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Ensures test plans meet regulatory requirements and identify potential EMC issues.
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Identifies potential EMC-related hazards and ensures device safety through thorough risk assessment.

Reviews

FAQ

What types of medical devices does TestCert test?

We provide testing services for a wide range of medical devices including diagnostic equipment, therapeutic devices, implantables, in-vitro diagnostics, and more. Our services cover both electrical and non-electrical medical devices.

What testing standards do you follow?

TestCert adheres to international testing standards such as ISO 13485, IEC 60601 series, ISO 14971 for risk management, and other relevant ISO and FDA guidelines to ensure device safety, performance, and regulatory compliance.

How long does testing usually take?

Testing timelines depend on the scope and complexity of the device and tests required. On average, testing takes between 2 to 8 weeks. We provide estimated timelines during the project planning phase.

What types of tests do you offer?

We offer a comprehensive suite of tests including:

  • Electrical safety and performance testing

  • Biocompatibility testing

  • Mechanical and durability testing

  • EMC (Electromagnetic Compatibility) testing

  • Chemical and toxicological testing

  • Sterilization validation

  • Packaging integrity tests

Do you assist with regulatory submissions?

Yes, TestCert offers consultancy to help you prepare technical documentation and test reports suitable for submission to regulatory authorities such as the FDA, CE marking bodies, and other international agencies.

Can TestCert test prototypes and pre-production devices?

Absolutely. We test both prototypes and production-ready devices to help you identify issues early and ensure compliance before mass production.

Opening Hour
Mon - Sat 8.00-18.00 Sunday - Closed
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