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.

Check out for this blog about Computed Tomography, X ray, MRI scan, ECG.

Generations of CT Scanners

COMPUTED TOMOGRAPHY|TECHNOLOGY|ARTIFACTS

x ray machine working principle

components of x ray tube

MRI scan

MRI With Contrast

Brain MRI

Types of MRI scanners

ELECTROCARDIOGRAM

12 Lead ECG Placement