Thursday, June 23, 2022

IEC 60601-1 Construction of Medical Electrical Equipment

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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


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 15: Construction of Medical Electrical Equipment as per IEC 60601-1.


Let's get into the topic.


Clause 15 - Construction of Medical Electrical

Equipment

 

The Clause 15 of IEC 60601-1 states the requirements for Construction of Medical Electrical Equipment. The following are the Sub-Clauses.


Arrangements of controls and indicators of Medical Electrical Equipment 

Serviceability

Mechanical strength

Medical Electrical Equipment components and general assembly

Mains Supply Transformers of Medical Electrical Equipment and transformers providing separation 

 

Let’s discuss in detail about Important requirements of above-mentioned Sub Clauses.

Serviceability:

The Parts of Medical Electrical Equipment which are likely to be replaced or adjusted due to electrical, mechanical wear and environmental degradation or ageing shall be located and secured in an appropriate position which allows inspection, servicing, replacement and adjustment without damage to the nearby parts or wiring.

 

Mechanical Strength:

The Medical Electrical Equipment or its parts shall have an adequate mechanical strength which prevents it from having a loss of basic safety and essential performance. The adequacy of Mechanical strength is determined by the application of following tests based on the Medical Electrical Equipment Type.


Hand-Held Type 

Push Test

Drop Test

Molding stress relief Test

 

Body Worn & Portable Type

Push Test

Impact Test

Drop Test

Molding stress relief Test


Mobile Type

Push Test

Impact Test

Rough handling Test

Molding stress relief Test


Fixed or Stationary Type 

Push Test

Impact Test

Molding stress relief Test


Medical Electrical Equipment components and general

assembly:

 

Construction of connectors

The Connectors of Medical Electrical Equipment shall be designed in such a way that the incorrect connection of accessible connectors and the removal of connectors without the use of tool shall be prevented.


Temperature and overload control devices

Over current releases and thermal cuts outs shall be independent and non-Self resetting.

 

Batteries

The incorrect polarity of the battery connection shall be prevented. The housing of the battery shall be properly ventilated to allow gases which produced due to charging and discharging of batteries to pass through.

 

Indicator

There shall be indicator lights to indicate that the Medical Electrical Equipment is ready for normal use. There shall be an indicator to indicate that the output exists for the Medical Electrical Equipment, in cases where the accidental or prolonged operation of output circuit might lead to a hazardous situation.


Actuating parts of controls of Medical Electrical Equipment

All actuating parts of the Medical Electrical Equipment shall be adequately secured such that they cannot work loose or pulled off during the normal use. All rotating or movable parts of controls in Medical Electrical Equipment shall be provided with stops of adequate mechanical strength to prevent it changing from Maximum controlled parameter to Minimum controlled parameter or vice versa.

 

Cord-connected Hand-Held and foot-operated control devices

When placed in an abnormal position, the Hand-Held and foot-operated control devices shall not present any unacceptable risk due to change in their controlled settings. The foot operated control devices shall be designed in a manner to support and withstand the weight of a adult human.

 

Mains Supply Transformers of Medical Electrical Equipment

and transformers providing separation:

 

In the event of short circuit or overload of any output winding, the transformers of Medical Electrical Equipment shall be protected from Short Circuit & Overload. The transformers shall undergo short circuit Test, Overload Test & Dielectric Strength test as per the requirements of IEC 60601-1.


Now I hope you have acquired some knowledge about IEC 60601-1 Clause 15: Construction of  Medical Electrical EquipmentWe 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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