Monday, November 21, 2022

IEC 60601-1 Excessive Temperatures

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


IEC 60601-1 Mechanical Hazards Moving Parts


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 Sub Clause 11.1: Excessive temperatures in Medical Electrical Equipment as per IEC 60601-1.


Let's get into the topic.


Excessive Temperatures in Medical Electrical

Equipment:

 


Maximum Temperature during Normal Use:

 

When the Medical Electrical Equipment is being operated in Worst case normal use condition, including maximum ambient temperatures, the Medical Electrical Equipment shall not reach temperatures mentioned in table 22 and table 23 of IEC 60601-1.

 

The temperatures at the surfaces of the test corners in the Medical Electrical Equipment shall not exceed 90°C.

 

The Thermal cut-outs shall not be used in normal condition.

Temperature of Applied Parts:


 

Applied Parts intended to supply heat to a patient:

 

The Risk Management File shall document the temperatures of hot or cold surfaces and its clinical effects where it’s appropriate.

 

Applied Parts not intended to supply heat to a patient:

 

If the surface temperatures at the applied parts of the Medical Electrical Equipment reaches above 41°C, the maximum temperatures attained shall be disclosed in the instructions for use.

 

The conditions for safe contacts such as but not limited to duration or condition of the patient shall be disclosed.

 

The Clinical effects with respect to different characteristics such as but not limited to body surface, maturity of patients shall be determined and documented in risk management file.

 

No justification is required, if the surface temperatures of the applied parts does not exceed 41°C

 

 

Measurements:

 

When the manufacturer provides the engineering judgement stating that the temperatures shall not exceed, then no measurement shall be required.

 

The Medical Electrical Equipment shall be tested in the position of its normal use.

 

During testing, The Medical Electrical Equipment having heating elements shall be operated as like in the normal use. All the heating elements shall be energized unless prevented by switching interlocks. The Supply voltage shall be equal to 100% of maximum rated voltage.

 

During testing, The Medical Electrical Equipment operated by motor shall be operated in its normal load and normal duty cycle. The motor shall be tested in least favourable voltage between 90% of the maximum rated voltage and 110% of the maximum rated voltage.

 

The Medical Electrical Equipment operated by the combination of both heating elements and motor shall be tested both at 90% of maximum rated voltage and 110% of maximum rated voltage.

 

For Medical Electrical Equipment operating in a non-continuous operation, once attaining a thermal stability after operating in standby mode, the medical electrical equipment shall be operated in normal use over consecutive cycles until thermal stability is reached again.

 

For Medical Electrical Equipment operating in a continuous operation, it shall be operated until thermal stability is reached.

 

The Temperature of windings shall be measured based on the Resistance Method.

 

The Thermocouple and other methods shall be used for all other measurements. The sensors and devices used for measurement shall be chosen and positioned in such a manner that the sensors and devices can have negligible effect on the temperature of the part under test.

 

The Temperature of electrical isolation other than windings shall be measured on the surface of the isolation where short circuit can happen as a result of failure.


Now I hope you have acquired some knowledge about IEC 60601-1 Sub Clause 11.1: Excessive Temperatures in Medical Electrical Equipment. 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


HOW TO READ AN ECG


Holter Monitor


DON’T FORGET TO FOLLOW THIS BLOG PAGE


DROP YOUR MAIL ID TO GET IMMEDIATE UPDATES


If you find this blog post knowledgeable, 

comment & share it with a friend! 


 


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 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 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.


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


HOW TO READ AN ECG


Holter Monitor


DON’T FORGET TO FOLLOW THIS BLOG PAGE


DROP YOUR MAIL ID TO GET IMMEDIATE UPDATES


If you find this blog post knowledgeable, 

comment & share it with a friend! 



Saturday, September 3, 2022

IEC 60601-1 Components and Wiring

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


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 Sub Clause 8.10: Components and Wiring as per IEC 60601-1.


Let's get into the topic.


Sub Clause 8.10: Components and Wiring

 

The Sub Clause 8.10 of IEC 60601-1 states the requirements for Components and Wiring. It is further classified as following.

 

Fixing of Components

Fixing of Wiring

Connections between different parts of Medical Electrical Equipment

Cord Connected Hand-Held parts & Cord Connected foot operated control devices

Mechanical Protection of Wiring

Guiding rollers for Insulated Conductors

Insulation of Internal Wiring

 

Let’s discuss in detail about the important requirements of above-mentioned Classifications.

Fixing of Components:

 

The Components of Medical Electrical shall be mounted securely to prevent the unwanted movement that could result in an unacceptable risk.


 

Fixing of Wiring:

 

The Conductors and Connectors of Medical Electrical Equipment shall be secured and insulated. The accidental detachment of Conductors and Connectors shall not result in a Hazardous Situation.


 
Connections between different parts of Medical Electrical

Equipment:

 

The Flexible Cords used for interconnection of different parts of Medical Electrical Equipment that are detachable without using the tool shall have a means of connection such that there is no compromise in the compliance of Metal Accessible Parts with the requirements of Clause 8.4 of IEC 60601-1 when a connection is loosened or broken due to the disengagement of one of the connecting means.


 

Cord Connected Hand-Held parts and Cord Connected foot

operated control devices:

 

Only the Conductors and Components which are operating at the voltages not exceeding 42.4 Peak Voltage AC and 60 Voltage DC in circuits isolated from the Mains Part by Two Means of Protection shall be present in the Cord Connected Hand-Held and Foot Operated Control devices of the Medical Electrical Equipment and their associated connection cords.


 

Mechanical Protection of Wiring:

 

The Adequate protection shall be provided for Internal Cables and Wiring against contact with the moving part or from friction at sharp corners and edges.

 

The Wiring, cord forms or the components of Medical Electrical Equipment shall be designed such that there shall not be any damage during the opening and closing of access covers or during the assembly.

Guiding rollers for Insulated Conductors:

 

In Medical Electrical Equipment, the Guiding rollers of insulated conductors shall be constructed in a such a manner that in Normal Use, the movable insulated conductors are not bent round a radius of less than 5 times the outer diameter of the concerned lead.


 

Insulation of Internal Wiring:

 

The Adequate protection shall be provided for the insulating sleeving present in the internal wiring of the Medical Electrical Equipment. The Sleeving which can be removed only by breaking or cutting shall be used to satisfy this requirement. The Sleeving that is secured at both ends shall also be used.

 

The Sheath of flexible cord present inside the Medical Electrical Equipment shall not be considered as a Means of Protection when it is exposed to thermal or mechanical stress outside of its rated characteristics.

 

During Normal Use, the Insulated Conductors of Medical Electrical Equipment shall experience a temperature exceeding 70 °C. So, the Insulated Conductors shall have an insulation of Heat Resistant Material because the deterioration of the insulation shall result in a Non-Compliance of the requirements of IEC 60601-1.

 

Now I hope you have acquired some knowledge about IEC 60601-1 Sub Clause 8.10: Components and Wiring. 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


HOW TO READ AN ECG


Holter Monitor


DON’T FORGET TO FOLLOW THIS BLOG PAGE


DROP YOUR MAIL ID TO GET IMMEDIATE UPDATES


If you find this blog post knowledgeable, 

comment & share it with a friend!