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! 


Friday, August 19, 2022

IEC 60601-1 Creepage Distance and Air Clearance

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


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 8.9: Creepage Distances and Air Clearances as per IEC 60601-1.


Let's get into the topic.


Sub Clause 8.9: Creepage Distances and Air

Clearances

 


The Sub Clause 8.9 of IEC 60601-1 states the requirements for Creepage Distances and Air Clearances.

 

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


 

Creepage Distance:

 

The Creepage Distance is the shortest distance between the two conductors along the insulating surface. The Creepage Distance must be greater than or equal to the Air Clearance.

 

Air Clearance:

 

Air Clearance is the Shortest Air path between two conductors.

 

The Creepage Distance & Air Clearance shall be derived from Table 12 – Table 16 in IEC 60601-1. If the Creepage Distance value is less than the values of Air Clearance, then the value of Creepage Distance shall be considered same as the Value of Air Clearance. The following are the overview of information provided in Table 12 -Table 16 of IEC 60601-1.

 

Table 12:

 

In Table 12, the Minimum Creepage Distance and Air Clearance Values can be derived based on d.c. & r.m.s. working Voltages for One Means of Patient Protection and Two Means of Patient Protection.

 

Table 13:

 

In Table 13, the Minimum Air Clearance Values providing Means of Operator Protection from Mains Part shall be derived based on Nominal Mains Voltage & Working Voltage.

 

Table 14:

 

In Table 14, additional Air Clearance values for Insulation in Mains Part shall be derived for Peak Working Voltage exceeding the Peak Value of Nominal Mains Voltage.

 

Table 15:

 

In Table 15, Minimum Air Clearance Values providing Means of Operator Protection in Secondary Circuit shall be derived based on Transient Value for Secondary Circuit & Working Voltage.

 

Table 16:

 

In Table 16, Minimum Creepage Distance Values providing Means of Operator Protection shall be derived based on Pollution Degree and Working Voltages.

 

 

 

The following conditions determine the Creepage Distance and Air Clearance:

 

Input Voltage.

Insulation.

Material Group.

Pollution Degree.

Overvoltage Category.

Altitude.

 

Let’s see in detail about some important above-mentioned conditions which determine the Creepage Distance & Air Clearance.


 

Material Group Classification:

 

The Material Group Classification is based on Comparative Tracking Index (CTI). The Electrical Breakdown properties of an Insulating Material is measured using CTI.

 

The Table 9 of IEC 60601-1 represents the Material Group Classification as Material Group 1, Material Group II, Material Group IIIa & IIIb Based on CTI Criteria.

 

If a Material Group for Insulating Material is unknown, then Material Group IIIb shall be considered.


 

Pollution Degree Classification:

 

The Pollution Degree is classified as Pollution Degree 1, Pollution Degree 2, Pollution Degree 3, Pollution Degree 4.

 

Pollution Degree 1:

The Pollution Degree I means Micro-Environment that is sealed, No Pollution Occurs.

 

Pollution Degree 2:

The Pollution Degree 2 means, occurrence of only Non-Conductive Pollution.

 

Pollution Degree 3:

The Pollution Degree 3 means, occurrence of Conductive Pollution or Dry Non-Conductive Pollution due to expected condensation.

 

Pollution Degree 4:

The Pollution Degree 4 means, occurrence of Continuous Conductivity due to conductive dust, rain and other wet conditions.


 

Overvoltage Category:

 

The Mains Transient Voltage value shall be determined based on the Overvoltage Category according to Normal AC Mains specified in Table 10 of IEC 60601-1.

 


Altitude:

 

The Medical Electrical Equipment shall be rated to operate at an altitude of Less than or equal to 2000m, unless specified by the manufacturer. If the Medical Electrical Equipment is intended to be operated in Pressurized Environment, then the Operating Altitude corresponding to the air pressure of the environment shall be used to determine the Multiplication factor based on Table 8 of IEC 60601-1. This Multiplication factor shall be used in Calculating the Air Clearance value.


Now I hope you have acquired some knowledge about IEC 60601-1 Sub Clause 8.9: Creepage Distances and Air Clearances. 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, July 16, 2022

IEC 60601-1 Leakage Currents and Patient Auxiliary Currents

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


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 8.7: Leakage Current and Patient Auxiliary Currents as per IEC 60601-1.


Let's get into the topic.


Sub Clause 8.7: Leakage Currents and Patient


Auxiliary Currents


The Sub Clause 8.7 of IEC 60601-1 states the requirements for Leakage Currents and Patient Auxiliary Current. It is further classified as following.


General Requirements

Single Fault Conditions

Allowable Values

Measurements

 

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

IEC 60601-1 Discusses about the following types of Current.

 

Touch Current:

The Touch Current is the amount of current that flows through a person when they touches one or more accessible parts of the Medical Electrical Equipment.


Earth Leakage Current:

The Earth Leakage Current is an electric current that flows into the Protective Earth Conductor through or via the insulation of the Medical Device.


Patient Auxiliary Current:

The Patient Auxiliary Current is an electric current which flows from one part of applied part to another part of applied part through the patient.


Patient Leakage Current:

The Patient Leakage Current is a leakage current which flows through the patient who is connected to a applied part or parts to the earth.


 

Allowable Values

 

The Protection against electric shock shall be provided by Electrical Isolation. The Electrical Isolation shall have a quality such that the current flowing through it shall be limited to the values specified in Clause 8.7.3 Allowable Values of IEC 60601-1.


The Below mentioned Allowable values shall be applicable in Single Fault Conditions mentioned in IEC 60601-1.


For Touch Current, the allowable value under Normal Condition is 100 μA and the allowable value under Single Fault Condition is 500 μA.


For Earth Leakage Current, the allowable value under Normal Condition is 5 mA and the allowable value under Single Fault Condition is 10 mA.

 

The Higher value of Earth Leakage Current is allowed for Medical Electrical Equipment which are permanently installed and are connected to supply circuit which supplies only this Medical Electrical Equipment.

 

The Allowable value for Patient Leakage Current & Patient Auxiliary Current shall be as per the requirements stated in Table 3 & 4 of IEC 60601-1


 

Measurements

 

General:

 

The Medical Electrical Equipment shall be in an operating temperature before measuring the Touch Current, Earth Leakage Current, Patient Auxiliary Current, Patient Leakage Current.

 

The Number of Tests shall be reduced when there is no possibility of any hazardous situations based on the arrangement of components and materials of Medical Electrical Equipment and examination of circuit arrangement.

 

Measuring Supply Circuits:

 

The Medical Electrical Equipment shall be connected to an appropriate power source when it is specified for connection to a Supply Mains.

 

The Medical Electrical Equipment which is supposed to be internally powered is tested without any connection to measuring supply circuit.

 

Connection to a Measuring Supply Circuits:

 

The Medical Electrical Equipment is tested while connected to the Measuring Supply Circuit when it is provided with an appliance inlet. In this case, the Medical Electrical Equipment is connected to Measuring Supply Circuit via detachable power cord of Length & Type as per the requirements of IEC 60601-1.

 

The Permanently Installed Medical Electrical Equipment is also tested while connected to the Measuring Supply Circuit.

 

Measurement of Touch Current, Patient Leakage Current & Patient Auxiliary Current:

 

The Circuit represented in Figure 14 – Figure 20 of IEC 60601-1 shall be used in the Measurement of Touch Current, Patient Leakage Current & Patient Auxiliary Current.

 

Multiple Patient Connection:

 

When there are Multiple Patient connections in a Medical Electrical Equipment, it is investigated to ensure that the allowable values do not exceed for Leakage Current and Patient Auxiliary Current when one or more patient connections are disconnected from the patient or disconnected from the patient and earthed.


Now I hope you have acquired some knowledge about IEC 60601-1 Sub Clause 8.7: Leakage Current and Patient Auxiliary Currents. 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!