Hi friends!!!

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

IEC 60601-1 Definitions

IEC 60601-1 Classification of Medical Electrical Equipment

IEC 60601-1 General Requirements for Testing Medical Electrical Equipment

IEC 60601-1 Medical Electrical Systems

EU MDR Assessment Routes

EU MDR Timeline, Annex, Chapter

EU MDR Post Market Surveillance

EU MDR Clinical Evaluation

EU MDR Technical Documentation – Part 1

EU MDR Technical Documentation – Part 2

EU MDR General Safety and Performance Requirement

EU MDR Information on the Label

EU MDR Post Market Clinical Follow Up

EU MDR Unique Device Identification – Part 1 

EU MDR Unique Device Identification – Part 2

EU MDR Classification Rules

EU MDR EUDAMED

EU MDR Economic Operators

EU MDR Chapter & Articles – Part 1

EU MDR Chapter & Articles – Part 2

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.