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 9.4: Instability Hazards as per IEC 60601-1.

Let’s get into the topic.

Instability
Hazards

General:

There
shall not be any overbalance such as tip over or unexpected movement in the Medical
Electrical Equipment or its parts which are supposed to be placed on the
surface such as floor or table during normal use.

Instability
Overbalance:

Instability
in Transport Position:

There
shall not be any overbalance when the Medical Electrical Equipment or its parts
placed in any transport position of normal use, on a plane which is inclined at
an angle of 10° from the
horizontal plane of the surface.

Instability
excluding Transport Position:

There
shall not be any overbalance when the Medical Electrical Equipment or its parts
placed in any position of normal use, excluding any transport positions, on a
plane inclined at an angle of 5° from the horizontal plane of the
surface.

If there
is any overbalance when the Medical Electrical Equipment or its parts placed in
any position of normal use, excluding any transport positions, on a plane
inclined at an angle of 10° from the horizontal plane of the
surface, then the Medical Electrical Equipment or its parts shall carry a
warning notice stating that the transportation shall only be undertaken in a
certain condition that shall be clearly stated in the instructions for use or
marked on the Medical Electrical Equipment.

Instability
from Horizontal and Vertical Positions:

There
shall not be any overbalance when the Medical Electrical Equipment or its parts
having a mass of 25 Kgs or more is being pushed, rested or leaned upon.

There
shall not be any overbalance when the Medical Electrical Equipment or its
parts, when it is being sat or stepped upon.

Castors
and Wheels:

There
shall not be more than 200N force required to move the mobile Medical
Electrical Equipment along the hard and flat horizontal surface.

The
Mobile Medical Electrical Equipment having more than 45 Kgs shall be able to
pass over a threshold of 10 mm. This passing over shall not result in
overbalancing.

Instability
from Unwanted Lateral Movement:

Instability
in Transport Position:

The
breaks of the power driven Mobile Medical Electrical Equipment shall be
designed in such a manner that it can be activated normally and released only
be the means of continuous actuation of the controls.

Any
unwanted movement of Mobile Medical Electrical Equipment or its parts shall be
prevented by fitting the equipment’s with means such a locking device.

The wheel
locks or braking system shall be provided in the Mobile Medical Electrical
Equipment to prevent an unwanted movement in an incline of 10° when it’s in the transport position.

Grips and
other Handling Devices:

The
suitable means of handling devices such as handles, lifting eyes etc shall be
provided with the Medical Electrical Equipment other than portable equipment’s
having a mass of more than 20 Kgs that need to be lifted during normal use or
in transportation.

When the
manufacturer specifies the Medical Electrical Equipment as Portable Equipment
which is having mass of more than 20 Kgs shall have one or more
carrying-handles which is placed suitably to enable the Medical Electrical
Equipment to be carried by two or more persons.

Now I hope you have acquired some knowledge about IEC 60601-1 Sub Clause 9.4: Instability 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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