Tuesday, March 28, 2023

IEC 60601-1 Separation of 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


IEC 60601-1 Mechanical Hazards Moving Parts


IEC 60601-1 Excessive Temperatures


IEC 60601-1 Markings on the Outside of Medical Electrical Equipment


IEC 60601-1 Markings on the Inside of Medical Electrical Equipment


IEC 60601-1 Separation of 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 8.5: Separation of Parts as per IEC 60601-1.


Let's get into the topic. 


Separation of Parts


Means of Protection:


General:

The Applied Parts & Accessible Parts of Medical Electrical Equipment shall have two means of protection to prevent from exceeding the limits specified in “Section 8.4 Limitation of voltage, current or energy” of IEC 60601-1.

The Two Means of Protection are following:

Means of Patient Protection (MOPP):

MOPP reduces risk of electric shock to patients.

Means of Operator Protection (MOOP):

MOOP reduces risk of electric shock to persons other than the patients.

 

The following shall not be regarded as a Means of Protection:

Varnishing

Enamelling

Oxidation

Similar protective finishes

Means of Patient Protection (MOPP) & Means of Operator Protection (MOOP):

The following are the requirements of MOPP & MOOP:

Dielectric Strength Test according to Section 8.8 of IEC 60601-1 shall be complied for Solid Insulation forming a Means of Patient Protection or Means of Operator Protection in Medical Electrical Equipment.

The Limits specified in “Table 12 – Minimum Creepage Distances and Air Clearances providing Means of Patient Protection” of IEC 60601-1 shall be complied for Creepage Distances and Air Clearances forming a Means of Patient Protection in Medical Electrical Equipment.

The Limits specified in “Table 13 – Table 16” shall be complied for Creepage Distances and Air Clearances forming a Means of Operator Protection in Medical Electrical Equipment.

The requirements of Section 8.6 of IEC 60601-1 shall be complied for Protective Earth Connections forming a Means of Patient Protection or Means of Operator Protection in Medical Electrical Equipment.

 

Separation of Patient Connections:

 

F Type Applied Parts:

The Patient Connections of any F-Type Applied Part shall be separated from all other parts of the Medical Electrical Equipment, including the Patient Connections of other Applied Part, by one Means of Patient Protection for the Working Voltage equal to the Maximum Mains Voltage. The One Means of patient Protection shall also comply with the specified Patient Leakage Current limits of 110% of the Maximum Mains Voltage.

There might be multiple functions in a single F Type Applied Part. In this case, it is not required to have a separation between such functions.

If the Patient Connections does not have an electrical separation between the same or another function, then these Patient Connections are considered as one Applied Part.

The Type BF, Type CF or Defibrillation-Proof classifications applies to the whole of one Applied Part.

 

B Type Applied Parts:

In Medical Electrical Equipment, the Patient Connections of a Type B Applied Part which are not Protectively Earthed shall be separated from metal Accessible Parts which are not Protectively Earthed by one Means of Patient Protection.

The above-mentioned requirement shall not be necessary if the risk of metal Accessible Part making contact with the source of voltage or Leakage Current above permitted limits is acceptably low and if the metal Accessible Part is physically touching the Applied Part and can be considered as a part of the Applied Part.

 

Patient Leads or Patient Cables:

Any connector for electrical connections to the patient lead which is connected at the end of the lead or cable that is remote distal from the patient shall be constructed so that the said part cannot become connected to earth or possible hazardous voltage while the Patient Connections contact the Patient.

Likewise, any connector for electrical connections to the patient lead which contains a conductive part that is not separated from all Patient Connections by one Means of Patient Protection for a Working Voltage equal to the Maximum Mains Voltage, shall be constructed so that the said part cannot become connected to earth or possible hazardous voltage while the Patient Connections contact the Patient.

 

Now I hope you have acquired some knowledge about IEC 60601-1 Sub Clause 8.5: Separation of PartsWe 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! 

Sunday, February 26, 2023

IEC 60601-1 Instability Hazards

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


IEC 60601-1 Excessive Temperatures


IEC 60601-1 Markings on the Outside of Medical Electrical Equipment


IEC 60601-1 Markings on the Inside of Medical Electrical Equipment


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 9.4: Instability Hazards as per IEC 60601-1.


Let's get into the topic.


Instability Hazards

 

General:

There shall not be any overbalance such as tip over or unexpected movement in the Medical Electrical Equipment or its parts which are supposed to be placed on the surface such as floor or table during normal use.

Instability Overbalance:

Instability in Transport Position:

There shall not be any overbalance when the Medical Electrical Equipment or its parts placed in any transport position of normal use, on a plane which is inclined at an angle of 10° from the horizontal plane of the surface.

Instability excluding Transport Position:

There shall not be any overbalance when the Medical Electrical Equipment or its parts placed in any position of normal use, excluding any transport positions, on a plane inclined at an angle of 5° from the horizontal plane of the surface.

If there is any overbalance when the Medical Electrical Equipment or its parts placed in any position of normal use, excluding any transport positions, on a plane inclined at an angle of 10° from the horizontal plane of the surface, then the Medical Electrical Equipment or its parts shall carry a warning notice stating that the transportation shall only be undertaken in a certain condition that shall be clearly stated in the instructions for use or marked on the Medical Electrical Equipment.

Instability from Horizontal and Vertical Positions:

There shall not be any overbalance when the Medical Electrical Equipment or its parts having a mass of 25 Kgs or more is being pushed, rested or leaned upon.

There shall not be any overbalance when the Medical Electrical Equipment or its parts, when it is being sat or stepped upon.

Castors and Wheels:

There shall not be more than 200N force required to move the mobile Medical Electrical Equipment along the hard and flat horizontal surface.

The Mobile Medical Electrical Equipment having more than 45 Kgs shall be able to pass over a threshold of 10 mm. This passing over shall not result in overbalancing.

 

Instability from Unwanted Lateral Movement:

Instability in Transport Position:

The breaks of the power driven Mobile Medical Electrical Equipment shall be designed in such a manner that it can be activated normally and released only be the means of continuous actuation of the controls.

Any unwanted movement of Mobile Medical Electrical Equipment or its parts shall be prevented by fitting the equipment’s with means such a locking device.

The wheel locks or braking system shall be provided in the Mobile Medical Electrical Equipment to prevent an unwanted movement in an incline of 10° when it’s in the transport position.


Grips and other Handling Devices:

The suitable means of handling devices such as handles, lifting eyes etc shall be provided with the Medical Electrical Equipment other than portable equipment’s having a mass of more than 20 Kgs that need to be lifted during normal use or in transportation.

When the manufacturer specifies the Medical Electrical Equipment as Portable Equipment which is having mass of more than 20 Kgs shall have one or more carrying-handles which is placed suitably to enable the Medical Electrical Equipment to be carried by two or more persons.


Now I hope you have acquired some knowledge about IEC 60601-1 Sub Clause 9.4: Instability HazardsWe 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! 

 


Sunday, January 22, 2023

IEC 60601-1 Markings on the Inside of Medical Electrical Equipment

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


IEC 60601-1 Excessive Temperatures


IEC 60601-1 Markings on the Outside of Medical Electrical Equipment


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 7.3: Markings on the Inside of Medical Electrical Equipment as per IEC 60601-1.


Let's get into the topic.

Markings on the Inside of Medical Electrical

Equipment


Heating Elements or Lamp Holders:

The Heating elements or lamp holders designed to be used with heating lamps shall be marked with information about maximum power loading near the heater or in the heater itself.

High Voltage Parts:

The Medical Electrical Equipment’s parts of high voltage shall be marked with the symbols of “Dangerous Voltage”, “Warning”, “Electricity” as specified in IEC 60601-1

                                                                       

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Batteries:

The markings for Type of Battery and Mode of Insertion shall be provided in the Medical Electrical Equipment.

In case the battery can only be removed by the service personnel with the use of tool, the marking referring to the information stated in the accompanying documents is sufficient. If any hazardous situation can happen due to incorrect replacement of battery like reversed polarity, a warning shall be provided along with the marking stating that replacement by inadequately trained personnel could lead to hazardous situation.

Fuses, Thermal Cuts, Over Current Releases:

Fuses, Replaceable Thermal Cuts, Over Current Releases of the Medical Electrical Equipment which can only be removed with the use of a tool shall be marked with the specifications adjacent to the component or shall be referred to the information in the accompanying documents.

Protective Earth Terminal:

Unless the Protective Earth Terminal is an appliance inlet, it shall be marked with the following symbol as specified in IEC 60601-1                                     

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Licensed under: CC Share Alike

Functional Earth Terminal:

The Functional Earth Terminal of Medical Electrical Equipment shall be marked with the following symbol as specified in IEC 60601-1                                                                         

Image courtesy: Wikimedia commons
Licensed under: CC Share Alike

Supply Terminals:

The Terminals which are supposed to be connected to the supply conductors shall be marked adjacent to the terminals.

The Terminals which are supposed to be connected exclusively to the neutral supply conductors shall be marked with the code as specified in IEC 60601-1

Temperature of Supply Terminals:

If the Terminal Box or wiring compartment attains a temperature of more than 75 °C during normal use and normal condition when it is intended to be used in connection with power supply conductors for permanently installed Medical Electrical Equipment, in this case the Medical Electrical Equipment shall be marked with information related to the minimum temperature requirements of wiring materials to be used in supply connections.

This information shall be marked near to or at the place where supply connections are to be made.

 

Markings of Controls and Instruments:

Power Switches:

The Switches which are used to Control the power of the Medical Electrical Equipment or its parts shall have its ON and OFF positions indicated by adjacent light & marked with symbols as specified in IEC 60601-1

Control Devices:

Figures, letters or other visual means shall be used to indicate the different positions of Control Devices and different positions of switches in the Medical Electrical Equipment.

In case the change of settings in a control during normal use shall lead to an unacceptable risk, such controls shall be provided with an indicating device.

Unit of Measurement:

Numeric Indications of parameters in the Medical Electrical Equipment shall be expressed in SI Units


Now I hope you have acquired some knowledge about IEC 60601-1 Sub Clause 7.3: Markings on the inside 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.


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!