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Medical Device

Medical Device

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Medical Device | Test

  •     Medical Device Test Outline

All medical devices must be taken for electrical safety test. Although many designers/ manufacturers are apt to mistakenly believe that first-class items, or products with low risk ratings, do not require permission and therefore do not have to comply with the electrical safety regulations, they must also meet the electrical safety requirements.

Most users think it's a good idea to make it mandatory to electrical safety test before launching the product. The standard for that electrical safety test is IEC 60601-1, which we know very well. Regulators in all countries around the world now require demonstrate suitability by the third edition of the IEC 60601-1 standard.

The important point is that, by adding the concept of risk in the third edition, it is no longer a test that can be found to be suitable by simply performing the test method as in the past.

IEC 60601-1 Safety Test

  • Electrical medical device test is based on product safety requirements to demonstrate basic safety and essential performance, with equipment complying with IEC/EN 60601 safety standards for electronic medical device product approval.

    All medical devices typically require approved laboratory test results and are controlled by strict local approval procedures. With respect to electrical medical devices, these requirements should be documented internationally in accordance with the criteria of IEC 60601 standard specifications.

    Now, IEC 60601-1 3rd edition is the basis for the approval process of electrical medical devices in most regulatory systems around the world. Due to the same requirements as the European Union's EN 60601 standard specification, IEC define a suitability about the Medical Device Directive (MDD) 93/42/EEC.

    Our testing laboratory provides generally accepted testing methods, test limits, and test levels for the evaluation of electrical medical devices in European and international standards, and provides all product safety tests according to the 60601-1 series of standards specification.

    IGC’s testing laboratories issue test reports for IEC international standards that can be used to perform tests in accordance with IEC/EN 60601 Safety Standards for electrical medical devices and obtain product safety certifications for electrical medical devices.

Capability of IGC’s Testing Laboratory

  • ✿ IGC provides management system certification services with recognition in the field of management systems from the U.S. accreditation body, IAS.

    ✿ IGC's assessors contribute to the continued development of customers by accurately assessing the suitability of the management system through many years of technical skills and expertise.

    ✿ IGC has up-to-date knowledge of a various specific range and legal requirements in major markets around the world and provides knowledge and services to support your overall global operations.

    Under the customer impression, based on
    more than 17 years of technology
    , know-how, and extensive certification experience, IGC operates a testing laboratory to support the testing and inspecting work required to obtain certification from customers. Starting with testing work about medical devices, electrical electron and machinery, we have expanded our scope to testing work about food products by achieving continuous development.

    From now on, IGC as a reliable professional testing and certification body, will continue to actively respond to changes with a challenge, research and development attitude and back to the basics and strive to grow together with the trust and belief of our customers.

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Related Services from IGC

  • 01CE LVD/EMC Certification

  • 02Eurasia Certification

  • 03Product Registration (CPNP, FDA)

  • 04Provide technical support services for testing and certification