Thursday, December 22, 2022

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 7.2: Markings on the outside of Medical Electrical Equipment as per IEC 60601-1.

Let's get into the topic.

Marking on the outside of ME Equipment or

ME Equipment parts:

Legibility & Durability:

The Markings on the Medical Electrical Equipment shall be clearly legible for the person viewing from the intended position of performing the related function.

The Markings on the Medical Electrical Equipment shall remain durable such that it can only be removed with the help of a tool or by applying an Appreciable force. The Markings shall be durable to remain clearly legible during the expected service life of the Medical Electrical Equipment.

Minimum Requirements:

If the size of Medical Electrical Equipment or its parts or its accessories does not allow provision for affixation of markings, then these markings shall be affixed in the accompanying documents or shall be affixed in the Individual packaging.

Identification:

The Medical Electrical Equipment, it’s detachable components or accessories shall have the markings about the Name or Trademark and the contact details of the Manufacturer, Model and Type reference, Serial Number, Batch or lot identifier, Date of Manufacture and use by date.

ME Equipment indented to receive power from other equipment:

If the Medical Electrical Equipment receives power from other equipment in the Medical Equipment system, then the compliance of IEC 60601-1 shall be dependent on the other equipment.

Connection to supply mains:

The Medical Electrical Equipment shall have markings about the Rated Supply Voltages or Voltage ranges to which it is connected. The Rated Voltage ranges shall have symbol hyphen (-) between the minimum and maximum voltages range. If the Medical Electrical Equipment uses Multiple Rates voltage ranges or Multiple supply voltages, then each shall be separated by symbol solidus (/).

Electrical Input power from the supply mains:

The Medical Electrical Equipment shall have markings about the Rated input voltages that it shall receive from the supply mains. The Rated input voltage shall be given in amperes or volt amperes or if the power factor exceeds 0.9 in amperes, volt amperes or watts.

Output Connectors:

The Medical Electrical Equipment with output connectors that intends to deliver power shall be marked with Rated current or power, output frequency, Rated output voltage.

Applied Parts:

The Medical Electrical Equipment’s applied parts shall be markings with respect to degree of protection against electrical shock, marked with relevant symbol. The relevant symbol shall be marked adjacent to the connector or on the connector for the applied part.

Mode of Operation:

If there is no marking with respect to Mode of Operation, then the Medical Electrical Equipment shall be considered as suitable for continuous operation. The Duty Cycle shall be marked with appropriate symbol showing Maximum Activation ON time & Deactivation OFF time for Medical Electrical Equipment having Non-Continuous Operation.

Fuses:

In case of fuse holder being an accessible part, type and full rating of the fuse shall be marked adjacent to fuse holder.

Cooling conditions and Protective Packaging:

The Medical Electrical Equipment’s requirements for cooling provisions shall be marked.

The special handling measures and permitted environmental conditions during transport and storage shall be marked outside the packaging.

Removal Protective Means:

In case, the alternate application of the Medical Electrical Equipment requires the removal of protective means, markings shall be made in the protective means to indicate the necessity for removal, when the function is no longer needed.

Now I hope you have acquired some knowledge about IEC 60601-1 Sub Clause 7.2: Markings on the outside of 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.

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x ray machine working principle

components of x ray tube

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MRI With Contrast

Brain MRI

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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.

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.

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