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 Clause 10: Protection against unwanted and excessive radiation hazards as per IEC 60601-1.

Let's get into the topic.

Clause 10 – Protection against unwanted and

excessive radiation hazards

The Clause 10 of IEC 60601-1 states the requirements for Protection against unwanted and excessive radiation hazards. The following are the Sub- Clauses.

X-Radiation

2. Alpha, beta, gamma, neutron and other particle radiation

3. Microwave radiation

4. Lasers

5. Other visible electromagnetic radiation

6. Infrared Radiation

7. Ultraviolet Radiation

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

X-Radiation

The Sub-Clause X -Radiation is further divided into following:

Medical Electrical Equipment not intended to produce

diagnostic or therapeutic X-Radiation:

If the Medical Electrical Equipment not intended to produce diagnostic or therapeutic X-Radiation but which can produce ionizing radiation, the Air Kerma Rate shall not exceed 5 μGy/h at a distance of 5 cm from the surface of the Medical Electrical Equipment considering the amount of background radiation.

If the Medical Electrical Equipment is operated permanently near the patient, then the annual exposure level shall be within the acceptable range considering the irradiated body part.

The radiation monitors of the ionizing chamber type with an effective area of 10 cm2 shall be used to determine the amount of radiation.

Medical Electrical Equipment intended to produce diagnostic or

therapeutic X-Radiation:

The Medical Electrical Equipment designed to produce diagnostic or therapeutic X-Radiation shall have unintended X-Radiation reduced at a level as far as possible by the application of particular or collateral standards or risk management process.

The Medical Electrical Equipment designed to produce X-Radiation for diagnostic imaging shall comply with the requirements of IEC 60601-1-3

Microwave Radiation

According to IEC 60601-1, the power density of unintended microwave radiation shall not exceed 10 W/m2 between frequencies 1 GHz and 100 GHz at any point 50 mm away from a surface of the Medical Electrical Equipment under reference test conditions.

The Internal pre-set controls of the Medical Electrical Equipment are not intended to be adjusted during the expected service life. The Measurements are made at a distance of 50 mm from any surface of the Medical Electrical Equipment to which the operators other than service personnel can gain access without the use of a tool or the operators other than the service personnel are deliberately provided with the means of access or the operators other than the service personnel are instructed to enter regardless of whether or not a tool is needed to gain access. Any measurement when tested under reference. If exceeding 10 W/m2 constitutes a failure.

Lasers

The requirements of IEC 60825-1:2014 shall be satisfied for lasers that produce or amplify electromagnetic radiation in the wavelength range from 180 nm to 1mm. It also includes Laser diodes.

Alpha, Beta, Gamma, Neutron and Other

Particle Radiation, Electromagnetic Radiation,

Infrared Radiation and Ultraviolet Radiation

The manufacturer shall address the risks associated with Alpha, Beta, Gamma, Neutron and other particle radiation in the risk management process. And also, the risks associated with Electromagnetic radiation, Infrared Radiation and Ultraviolet Radiation apart from those that are produced by lasers shall be considered in Risk management process by the manufacturer.

Now I hope you have acquired some knowledge about IEC 60601-1 Clause 10: Protection against Unwanted and Excessive Radiation Hazards. 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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