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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.
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.
The following are the important stages .
|01||Determine 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|
|02||If 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|
|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
|04||The manufacturer has to prepare an isolation diagram|
|05||Prepare the specification sheets of the Critical components|
|06||Identify 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.
|07||Test 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.
|08||Review the essential marking and labeling Requirement|
|09||Review 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|
|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
|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
|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.|
|Ensure the timeline for the project|
|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