Friday, October 21, 2022

IEC 60601-1 Mechanical Hazards Moving Parts

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

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 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 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 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



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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