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    Electrical Safety Testing of Medical Equipment

    The main purpose of performing an Electrical Safety Testing of medical equipment is to ensure patient safety. It is carried out to evaluate the potential risks of electrical shocks to customers when using their products.

    IEC 60601-1 Testing

    Electrical Safety Testing is essential to ensure safe operating standards for any product that uses electricity ( Directly or Indirectly) IEC 60601 is a series of technical standards for the safety and essential performance of medical electrical equipment, published by the International Electrotechnical Commission.

    IEC 60601-1:2018

    The following are the important stages .

    01Determine the medical device contain the electrical energy or the accessory of electrical device
    Check the applicability of the standard IEC 60601-1 scope on the device
    02If the IEC 60601-1 standard is applicable, determine the set of collateral standards of IEC 60601-1-X are applicable
    For CE marking determine the harmonized standard sets in the EN 60601-1-X and are below

    • EN 60601-1-1:2001- Safety requirements for medical electrical systems
    • EN 60601-1-2:2015- Electromagnetic disturbances – Requirements and tests
    • EN 60601-1-3:2008- Radiation protection in diagnostic X-ray equipment
    • EN 60601-1-4:1996- Programmable electrical medical systems
    • EN 60601-1-6:2010- Usability
    • EN 60601-1-8:2007-General requirements, tests, and guidance for alarm systems in medical electrical equipment and medical electrical systems
    • EN 60601-1-10:2008- Requirements for the development of physiologic closed-loop controllers
    • EN 60601-1-11:2010- Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

    03

    Determine the class of the device and the particular standards IEC 60601-2-X, IEC 60601-2-2 and ISO/IEC 80601-2-XX applicable
    Class I – MD with a grounded power source, Class II – MD without a grounded power source, Other MEE – MD with the internal power source.

    Other classifications are below

    • Check the rating for protection against harmful ingress of water and particulate matter.
    • Method of sterilization
    • Suitability for an oxygen-rich environment
    • Mode of operation (is it continuous or noncontinuous?)
    • Is it transportable or stationary?
    • Based on this classification the standard sets are determined.
      04The manufacturer has to prepare an isolation diagram
    • Isolation based on the means of protection are prepared below
    • Basic insulation
    • Double or reinforced insulation
        05Prepare the specification sheets of the Critical components
    • The documents to be arranged for the critical components are below
    • UL component certification and COA
    • Engineering specifications
    • Engineering drawings
    • Test certifications and reports of components
    • CB certificate and test report for power supplies
    • Label Material
        06Identify the electrical risks based on the essential performance
    Clause 4.3 of IEC 60601-1, edition 3.1, and standards, the Essential performance are determined and the identified risks in both normal and faulty states are addressed in the RMF.

    The essential performance will apply to critical care equipment such as those for anesthesia or ICU monitors, but others also apply.

    The documents with the RMF requirements should be passed on to the lab for the test reports in compliance to the IEC 60601-1. Simplify the risks identified in the RMF should be tested for the safety in the Lab as per the IEC 60601 collateral and particular standards.

        07Test article selection
    The sample selected for the IEC 60601 testing should be the final product and meets the requirements of the standard.

    All together a test plan should be prepared from the lab. But EMC (IEC 60601-1-2) should have a separate test plan. All applicable, as well as non-applicable tests as per the clauses of the standards, should be part of the plan.

        08Review the essential marking and labeling Requirement
    • Review all symbols, safety signs, switches, and units of measure.
    • User manual
    • Service manual
    • Check all labeling requirements within the collateral and standards.
        09Review of the Reports of the Test
    According to the Essential requirements specific for the devices, the test reports are reviewed for the applicability of each clause in the collateral and particular standards of IEC 60601

    10

    Check the regulatory status of the testing Laboratory
    Solid test reports to support your regulatory submission(s) and a good reputation.
    All the clauses applicable for your device should be able to be tested in the same lab.
    Avoid maximum the Labs testing specific regulatory bodies requirements like FDA, EU, etc

    11

    Finalize the RMF and the essential performance
    After the test reports checked the RMF is finalized with the output of the test reports.
    The clinical evaluation writes up also updated for the assurance of safety with the reference of the test reports

    12

    Consider a pre-testing
    For new technology, devices try for an in -house testing for compliance. If your device fails pre-testing, you need to look at whether it requires a redesign.

    13

    Ensure the timeline for the project
    • Prepare all the supporting documents ready before performing the tests
    • Marking and labeling proper
    • Signed agreement with the test lab
    • Proper payment
    • Critical component Certification documents
    • Make the sample to be tested ready on time.

    14

    Proper tracking of the test reports
    Correct communication with the test lab. Usually, 2-4 weeks for the test report to receive if all the above items ready.
    The technical reports standards- IEC/TR 60601-4-2, IEC/TR 60601-4-3