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In our previous blogs, we have discussed about the following topics.

In today's blog, we are going to discuss about IEC 60601-1.

IEC 60601-1 states the Basic safety requirements for Medical Electrical Equipment's. Satisfying the requirements of IEC 60601-1 is an important task in order to commercialize the Medical Electrical Equipment's

Therefore, it is important for Medical Device QA/RA Professionals to know in detail about Clause 5: General Requirements for Testing Medical Electrical Equipment as per IEC 60601-1.

Let's get into the topic.

Clause 5: General Requirements for

Testing Medical Electrical Equipment

Clause 5 of IEC 60601-1 states the general requirements for testing the Medical Electrical Equipment. The following are the Sub-Clauses.

5.1 Type Tests.

5.2 Number of Samples.

5.3 Ambient Temperature, Humidity and Atmospheric Pressure.

5.4 Other Conditions.

5.5 Supply Voltages, Type of current, Nature of Supply, Frequency.

5.6 Repairs and Modifications.

5.7 Humidity Preconditioning Treatment.

5.8 Sequence of Tests.

5.9 Determination of Applied Parts and Accessible Parts.

Let’s discuss in detail about Important requirements of above-mentioned Sub Clauses.

Type Tests

All the Tests mentioned in IEC 60601-1 are called as Type Tests. The Tests which need to be performed are determined based on the requirements of Clause 4 General Requirements, specially based on the requirements of Clause 4.2 Risk Management Process for Medical Electrical Equipment and Medical Electrical Systems.

Ambient Temperature, Humidity and Atmospheric Pressure

Once the Medical Electrical Equipment to be tested has been set up for Normal Use (as per Clause 5.7 Humidity Pre-conditioning Treatment), tests need to be performed within the range of environmental conditions specified in the technical description. The Medical Electrical Equipment is shielded from other influences which might affect the validity of the tests. In cases when ambient temperatures cannot be maintained, the test conditions are to be consequently modified and the test results need to be adjusted accordingly.

Other Conditions

Important requirement of Clause 5 is that it requires testing to be conducted under the least-favorable operating conditions.

Supply Voltages, Type of current, Nature of Supply, Frequency

The Medical Electrical Equipment having a Mains Part intended to be connected with A.C. Supply Mains is only tested with A.C. at a rated frequency. In case of rated frequency range, the Medical Electrical Equipment needs to be tested at the least favorable frequency within that range. The Medical Electrical Equipment having a Mains Part intended to be connected with D.C. Supply Mains is only tested with D.C. The Influence of Polarity also needs to be considered. In case, the Medical Electrical Equipment are designed for both A.C. and D.C. or Internal and External Power Source, the tests are to be conducted at the least favorable voltage and nature of supply.

Humidity Preconditioning Treatment

Prior to the testing as per Clause 8.7.4 (Leakage Current and Patient Auxiliary Current) and Clause 8.8.3 (Dielectric Strength), the Medical Electrical Equipment shall undergo Humidity Preconditioning Treatment. The Medical Electrical Equipment parts which are influenced by the climatic conditions that are simulated by the test, will only undergo Humidity Preconditioning Treatment.

Determination of Applied and Accessible Parts

The Applied Parts can be identified by referencing the accompanying or supporting documents.

The Accessible Parts can be identified by testing the Medical Electrical Equipment using a Standard Test Finger. The Test Finger can be applied in a Straight or Bent position. Other ways to identify the Accessible Parts, is by testing the Medical Electrical Equipment opening by means of a Test Hook.

If the Conductive parts of actuating mechanisms of electrical controls are accessible after the removal of handles, knobs, levers, it is considered as Accessible Parts. Meanwhile if the handles, knobs, levers, are removable using a tool, then the Conductive Parts of actuating mechanisms are not considered Accessible Parts.

Now I hope you have acquired some knowledge about IEC 60601-1 Clause 5: General Requirements for Testing Medical Electrical Equipment. We will meet again with another valuable topic related to Biomedical Engineering, Medical Device, Healthcare.

NOTE: Dear friends!!!... Please do comment a topic related to Biomedical, so that we can discuss it in future blogs.

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