Thursday, June 23, 2022

IEC 60601-1 Construction 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


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.


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! 


 

Monday, June 6, 2022

IEC 60601-1 Hazardous situations and fault condition

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 


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 13: Hazardous situations and fault conditions for Medical Electrical Equipment as per IEC 60601-1.


Let's get into the topic.


Clause 13 – Hazardous Situations and fault

conditions for Medical Electrical Equipment


The Clause 13 of IEC 60601-1 states the requirements of Hazardous situations and fault conditions for Medical Electrical Equipment. The following are the Sub-Clauses.

 

  1. Specific Hazardous Situations
  2. Single Fault Conditions


Specific Hazardous Situations:

The Specific Hazardous Situations shall be further classified as following.

 

Deformation of enclosure, Emissions or exceeding maximum temperature:

The following Hazardous Situations shall not occur:


1. The Emission of molten metal, flames, poisonous or ignitable substances in hazardous quantities. 

2. The deformation of Enclosures shall not occur to an extent which can cause a non-compliance with requirements in IEC 60601-1.

3. The Temperatures of Applied Parts shall not exceed the allowed values.

4. The Temperatures of Medical Electrical Equipment parts other than Applied Parts which are likely to be touched shall not exceed the allowed values.

5. The Temperatures of Accessible Parts which are likely to be touched but are not supposed to be touched to operate the Medical Electrical Equipment shall not exceed the allowed values.

6. The Temperatures of Accessible Parts which are supposed to be touched to operate the Medical Electrical Equipment shall the exceed the allowed values mentioned.

 

Exceeding Leakage Current or voltage limits:

The following Hazardous Situations shall not occur:


1. The allowed limits for leakage current in Single Fault Condition shall not exceed.

2. The allowed voltage limits for Applied Parts and Accessible Parts shall not exceed.

Single Fault Conditions:

During the application of the Single Fault Conditions listed below, the Normal Conditions identified as per IEC 60601-1 shall also be applied in the least favorable combination.

 

The Single Fault Conditions are as following:

 

1.    Electrical Single Fault Condition

2.    Overheating of transformers in Medical Electrical Equipment

3.    Failure of Thermostats

4.    Failure of temperature limiting devices


5.    Leakage of Liquid


The Medical Electrical Equipment shall be constructed in such a way when there is a liquid leakage during a Single Fault Condition, only a small amount of liquid leaks. The sealed rechargeable batteries are exempted from this requirement.


6.    Impairment of cooling that could result in a Hazardous Situation


The following are few of examples related to Impairments of cooling that can occur: 

The consecutive locking of single ventilation fans.

The covering of ventilation openings in top and sides of the enclosure or the Medical Electrical  Equipment’s are placed against the walls.

The blockage of filters.

Interruption in the flow of cooling agent.


7.    Locking of Movable Parts


In Medical Electrical Equipment, the moving parts are locked if it has moving Accessible Parts or Applied Parts which are liable to be jammed or liable to be operated when unattended (this includes automatically or remotely controlled Medical Electrical Equipment), or it has one or more motors with a locked rotor torque smaller than the full load torque.

If Medical Electrical Equipment has more than one moving part as described above, only one moving part is locked at a time. If multiple motors can. be locked in a Single Fault Condition, then all motors are locked simultaneously


8.    Interruption and short circuiting of motor capacitors

9.    Additional test criteria for motor operated Medical Electrical Equipment

10.  Failures of components in Medical Electrical Equipment used in conjunction with Oxygen Rich Environments

11.   Failure of parts that might result in a Mechanical Hazard

12.    Overload


Now I hope you have acquired some knowledge about IEC 60601-1 Clause 13: Hazardous situations and fault conditions for 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! 


Saturday, May 14, 2022

IEC 60601-1 Programmable Electrical Medical Systems

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


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 14: Programmable Electrical Medical Systems as per IEC 60601-1.


Let's get into the topic.


Clause 14 – Programmable Electrical Medical Systems


The Clause 14 of IEC 60601-1 states the requirements of Programmable Electrical Medical Systems. The following are the Sub-Clauses.


General

Documentation

Risk Management plan

PEMS Development Life-Cycle

Problem resolution

Risk Management Process

Requirement specification

Architecture

Design and implementation

Verification

PEMS Validation

Modification

PEMS intended to be incorporated into an IT-Network


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

 

Risk Management Plan:

The PEMS Validation Plan shall be referenced in Risk Management Plan.

 

PEMS Development Life-Cycle: 

Milestones shall be defined at each stage of PEMS Development Life-Cycle. Each milestone shall have the details of verification methods and activities to be completed. Each activity listed in the milestone shall have details about its input and output. The PEMS Development Life-Cycle shall follow risk-based approach.

The PEMS Development Life-Cycle has certain attributes. All the activities in PEMS Life-Cycle shall be grouped into decomposition process and integration process.

Requirement Specification: 

Each Subsystem of PEMS shall have requirement specification document. The requirement specification shall have details about essential performance of Subsystem and risk controls implemented.


Architecture:

Each Subsystem of PEMS shall have architecture which satisfies the requirement specification.

The architecture shall be framed to reduce the risk to an acceptable level by making use of Components with High Integrity, fail safe functions, redundancy, defensive design, test interval duration & diagnostic coverage, protection from reasonably foreseeable misuse, etc.


Design and Implementation:

Each Subsystems of PEMS shall have a Design and Test Specification.


Verification: 

Each function which ensures basic safety, essential performance, and risk control measures shall be verified. The Verification shall be performed for each function at each milestone. A Verification Plan shall be created to decide on the strategies and methods of verification. The strategies and methods of verification shall include Statistical Techniques, Inspections, Dynamic Analysis etc.

The Verification shall be performed as per the plan and the results shall be documented.

 

Validation:

The Person responsible for overall validation shall be independent from the Design Team. No member of the design team shall perform PEMS Validation of their own design. The rationale for the level of independence shall be given by the manufacturer.

The Validation shall be performed as per the plan and the results shall be documented. 

 

Programmable Electrical Medical Systems intended to be incorporated into an IT-Network: 

If the PEMS is intended to be incorporated into an IT-Network which is not validated by Manufacturer. The instructions for implementing such connection shall be made available by the manufacturer which shall include the following:

The purpose of the Programmable Electrical Medical Systems connection to an IT-Network shall be available.

The required characteristics and configuration of the IT-Network incorporating the PEMS.

The technical and security specifications of the network shall be available.

During the incorporation of PEMS to IT Network, there will be subsequent changes in the IT Network which can introduce new risks and raises the requirement to perform additional analysis.

 

The changes to the IT Network shall include the following:

The change in the configuration of IT Network.

Disconnection of items from the IT Network.

The update of equipment connected to the IT Network

 

Now I hope you have acquired some knowledge about IEC 60601-1 Clause 14: Programmable Electrical Medical Systems. 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!