Hi friends!!!
In our previous blogs, we have discussed about the following topics.
IEC 60601-1 Classification of Medical Electrical Equipment
IEC 60601-1 General Requirements for Testing Medical Electrical Equipment
IEC 60601-1 Medical Electrical Systems
IEC 60601-1 Protection against unwanted and excessive radiation hazards
IEC 60601-1 General Requirements
IEC 60601-1 Programmable Electrical Medical Systems
IEC 60601-1 Hazardous situations and fault condition
IEC 60601-1 Construction of Medical Electrical Equipment
IEC 60601-1 Leakage Currents and Patient Auxiliary Currents
IEC 60601-1 Creepage Distance and Air Clearance
IEC 60601-1 Components and Wiring
EU MDR Timeline, Annex, Chapter
EU MDR Post Market Surveillance
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 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 Sub Clause 9.2: Mechanical Hazards associated with Moving Parts as per IEC 60601-1.
Let’s get into the topic.
Mechanical Hazards associated with
Moving
Parts
Trapping Zone:
The Medical Electrical Equipment with
Trapping Zone shall comply with the following requirements of Gaps, Safe
Distances, Guards, Continuous Activation, Speed of Movements as specified in
IEC 60601-1. The Trapping Zone is considered not to present a Mechanical Hazard
if these requirements are fulfilled.
Guards and other Risk Control Measures:
Guards shall be of Robust construction.
Guards shall not be easy to bypass or
non-operational.
Guards shall not introduce any
additional unacceptable risk.
There are two types of Guards:
Fixed Guards:
The Fixed Guards shall not be
dismantled without the use of a tool.
Movable Guards:
The Moving parts shall be associated
with a interlock device, which prevents the moving parts from starting to move
when the trapping zone is accessible and stops the movement when the guards are
open.
The moving parts shall be designed and
constructed in such a manner when it is in reach of persons, it shall not start
to move.
Continuous Activation:
The Continuous Activation can be used
as a risk control measure, when it is impossible to make a trapping zone
inaccessible.
The movement of the Medical Electrical
Equipment shall be within the operator’s field of view.
The Medical Electrical Equipment &
its parts shall be moved only by the continuous activation of control by the
operator as long as the response of the operator can be relied upon to prevent
the harm.
One or more emergency stopping device
shall be provided as a risk control measure, in case the continuous activation
system is defeated in a single fault condition.
Speed of Movements:
The Speed of movements shall be
controlled, so that the operator have a adequate control over the
movements. The overtravel occurring after the operation of control to stop the
movements shall not result in a unacceptable risk.
Other Mechanical Hazards associated
with Moving Parts:
Unintended Movement:
The Medical Electrical Equipment’s
control shall be positioned, recessed and protected in such a manner that it
cannot be actuated accidentally.
Overtravel End Stops:
Overtravel past the range limits of the
Medical Electrical Equipment parts shall be prevented. The Ultimate travel
limiting measure shall be provided by End stops and other stopping mechanisms.
Such mechanism shall have the sufficient mechanical strength to withstand the
intended loading during the Normal Use and reasonably foreseeable misuse.
Emergency Stopping Devices:
The following are few of the
requirements that needs to be complied where it is considered to have one or
more Emergency Stopping Devices:
The Operator shall be in such a
position to readily access the emergency stopping device.
The emergency stopping device shall not
be a part of the normal operation of the device.
One single action shall only be
required as a means for stopping of movements.
The actuator of the emergency stopping
device shall be coloured red and be easily identifiable from other controls
Release of Patient:
Means shall be provided such that the
Patient will be released quickly and safely from the Medical Electrical
Equipment in the event of breakdown or loss of power supply.
Now I hope you have acquired some knowledge about IEC 60601-1 Sub Clause 9.2: Mechanical Hazards associated with Moving Parts. 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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