Hi friends!!!

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 Sub Clause 11.1: Excessive temperatures in Medical Electrical Equipment as per IEC 60601-1.

Let's get into the topic.

Excessive Temperatures in Medical Electrical

Equipment:

Maximum Temperature during Normal Use:

When the Medical Electrical Equipment is being operated in Worst case normal use condition, including maximum ambient temperatures, the Medical Electrical Equipment shall not reach temperatures mentioned in table 22 and table 23 of IEC 60601-1.

The temperatures at the surfaces of the test corners in the Medical Electrical Equipment shall not exceed 90°C.

The Thermal cut-outs shall not be used in normal condition.

Temperature of Applied Parts:

Applied Parts intended to supply heat to a patient:

The Risk Management File shall document the temperatures of hot or cold surfaces and its clinical effects where it’s appropriate.

Applied Parts not intended to supply heat to a patient:

If the surface temperatures at the applied parts of the Medical Electrical Equipment reaches above 41°C, the maximum temperatures attained shall be disclosed in the instructions for use.

The conditions for safe contacts such as but not limited to duration or condition of the patient shall be disclosed.

The Clinical effects with respect to different characteristics such as but not limited to body surface, maturity of patients shall be determined and documented in risk management file.

No justification is required, if the surface temperatures of the applied parts does not exceed 41°C

Measurements:

When the manufacturer provides the engineering judgement stating that the temperatures shall not exceed, then no measurement shall be required.

The Medical Electrical Equipment shall be tested in the position of its normal use.

During testing, The Medical Electrical Equipment having heating elements shall be operated as like in the normal use. All the heating elements shall be energized unless prevented by switching interlocks. The Supply voltage shall be equal to 100% of maximum rated voltage.

During testing, The Medical Electrical Equipment operated by motor shall be operated in its normal load and normal duty cycle. The motor shall be tested in least favourable voltage between 90% of the maximum rated voltage and 110% of the maximum rated voltage.

The Medical Electrical Equipment operated by the combination of both heating elements and motor shall be tested both at 90% of maximum rated voltage and 110% of maximum rated voltage.

For Medical Electrical Equipment operating in a non-continuous operation, once attaining a thermal stability after operating in standby mode, the medical electrical equipment shall be operated in normal use over consecutive cycles until thermal stability is reached again.

For Medical Electrical Equipment operating in a continuous operation, it shall be operated until thermal stability is reached.

The Temperature of windings shall be measured based on the Resistance Method.

The Thermocouple and other methods shall be used for all other measurements. The sensors and devices used for measurement shall be chosen and positioned in such a manner that the sensors and devices can have negligible effect on the temperature of the part under test.

The Temperature of electrical isolation other than windings shall be measured on the surface of the isolation where short circuit can happen as a result of failure.

Now I hope you have acquired some knowledge about IEC 60601-1 Sub Clause 11.1: Excessive Temperatures in 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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