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Electrical Safety Testing of Medical Devices

The main purpose of performing electrical safety testing of medical devices 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.

IEC 60601-1:2018

The following are the important stages .

01	Determine the medical device contain the electrical energy or the accessory of the 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 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.
04	The manufacturer has to prepare an isolation diagram
	Isolation based on the means of protection are prepared below Basic insulation Double or reinforced insulation
05	Prepare 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
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 labelling Requirement
	Review all symbols, safety signs, switches, and units of measure. User manual Service manual Check all labelling requirements within the collateral and standards.
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
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 to 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 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 labelling 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