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


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Saturday, April 30, 2022

IEC 60601-1 General Requirements

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


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 4: General Requirements as per IEC 60601-1.


Let's get into the topic.


Clause 4 – General Requirements 

The Clause 4 of IEC 60601-1 states the General requirements of Medical Electrical Equipment. The following are the Sub-Clauses.


  1. Conditions for application to Medical Electrical Equipment or Medical Electrical Systems.
  2. Risk Management Process for Medical Electrical Equipment or Medical Electrical Systems.
  3. Essential Performance.
  4. Expected Service Life.
  5. Alternative Risk Control measures or test methods for Medical Electrical Equipment or Medical Electrical Systems.
  6. Medical Electrical Equipment or Medical Electrical System parts that contact the Patient.
  7. Single Fault Condition for Medical Electrical Equipment.
  8. Components of Medical Electrical Equipment.
  9. Use of Components with High-Integrity Characteristics in Medical Electrical Equipment.
  10. Power supply.
  11. Power input

 

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


Risk Management Process for Medical Electrical Equipment or Medical Electrical Systems:

Risk Management Process complying with ISO 14971:2019 shall be performed & required. The requirements of IEC 60601 shall not be satisfied unless complying with the requirements of ISO 14971. The Compliance to IEC 60601 in many cases is checked by inspecting the Risk Management File.


Essential Performance:

Essential Performance means a performance, of a clinical function, other than that related to Basic Safety, where loss or degradation beyond the limits specified by the manufacturer results in an unacceptable risk.

During Risk Analysis, the manufacturer shall identify the Essential Performance of the Medical Electrical Equipment or Medical Electrical Systems. The manufacturer shall specify performance limits between fully functional & total loss of the identified performance in both the Medical Electrical Equipment or Medical Electrical Systems under Normal Condition & Single Fault Condition.

Expected Service Life:

The Expected Service Life shall be stated in the Risk Management File by the Manufacturer.

 

Alternative Risk Control measures or test methods for Medical Electrical Equipment or Medical Electrical Systems:

The Alternate Risk Control measures or Test Methods apart from those that are specified in IEC 60601-1 shall be used until the residual risk arising from such alternate risk control measures or test methods is relatively low when compared to the risk control measures or test methods specified in IEC 60601-1.

 

Medical Electrical Equipment or Medical Electrical System parts that contact the Patient:

The Risk Management Process shall determine the parts which come in contact with the patient apart from the parts which are specified as Applied Parts. Such parts shall also confirm to the requirements of applied parts and are considered as Type B Applied Part unless and otherwise identified as Type BF Applied Part or Type CF Applied Part.

 

Components of Medical Electrical Equipment:

All components of Medical Electrical Equipment including the wiring shall be used as per their specified ratings. The reliability of the components which are used as a Means of Protection shall be tested based on the conditions of use in the Medical Electrical Equipment.

 

Power supply:

The Medical Electrical Equipment shall be suitable to use in connection with supply mains. The Rated Voltages for Supply Mains shall be 250v for Handheld Devices and 500v for other Medical Electrical Equipment or Medical Electrical Systems.

 

Power input:

The measured Power input of Medical Electrical Equipment or Medical Electrical System at a specified Rated Voltage and Operating conditions shall not exceed the marked Power input rating by more than 10%.


Now I hope you have acquired some knowledge about IEC 60601-1 Clause 4: General Requirements. 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, April 22, 2022

IEC 60601-1 Protection against Unwanted and Excessive Radiation 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


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 10: Protection against unwanted and excessive radiation hazards as per IEC 60601-1.


Let's get into the topic.


Clause 10 – Protection against unwanted and

excessive radiation hazards


The Clause 10 of IEC 60601-1 states the requirements for Protection against unwanted and excessive radiation hazards. The following are the Sub- Clauses.

X-Radiation

2.      Alpha, beta, gamma, neutron and other particle radiation

3.      Microwave radiation

4.      Lasers

5.      Other visible electromagnetic radiation

6.      Infrared Radiation

7.      Ultraviolet Radiation

 

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

X-Radiation

The Sub-Clause X -Radiation is further divided into following:

 

Medical Electrical Equipment not intended to produce 

diagnostic or therapeutic X-Radiation:

If the Medical Electrical Equipment not intended to produce diagnostic or therapeutic X-Radiation but which can produce ionizing radiation, the Air Kerma Rate shall not exceed 5 μGy/h at a distance of 5 cm from the surface of the Medical Electrical Equipment considering the amount of background radiation.

If the Medical Electrical Equipment is operated permanently near the patient, then the annual exposure level shall be within the acceptable range considering the irradiated body part.

The radiation monitors of the ionizing chamber type with an effective area of 10 cm2 shall be used to determine the amount of radiation.

 

Medical Electrical Equipment intended to produce diagnostic or

therapeutic X-Radiation:

The Medical Electrical Equipment designed to produce diagnostic or therapeutic X-Radiation shall have unintended X-Radiation reduced at a level as far as possible by the application of particular or collateral standards or risk management process.

The Medical Electrical Equipment designed to produce X-Radiation for diagnostic imaging shall comply with the requirements of IEC 60601-1-3

 

Microwave Radiation

According to IEC 60601-1, the power density of unintended microwave radiation shall not exceed 10 W/m2 between frequencies 1 GHz and 100 GHz at any point 50 mm away from a surface of the Medical Electrical Equipment under reference test conditions.

The Internal pre-set controls of the Medical Electrical Equipment are not intended to be adjusted during the expected service life. The Measurements are made at a distance of 50 mm from any surface of the Medical Electrical Equipment to which the operators other than service personnel can gain access without the use of a tool or the operators other than the service personnel are deliberately provided with the means of access or the operators other than the service personnel are instructed to enter regardless of whether or not a tool is needed to gain access. Any measurement when tested under reference. If exceeding 10 W/m2 constitutes a failure.

 

Lasers

The requirements of IEC 60825-1:2014 shall be satisfied for lasers that produce or amplify electromagnetic radiation in the wavelength range from 180 nm to 1mm. It also includes Laser diodes.

 

Alpha, Beta, Gamma, Neutron and Other

Particle Radiation, Electromagnetic Radiation,

Infrared Radiation and Ultraviolet Radiation  

The manufacturer shall address the risks associated with Alpha, Beta, Gamma, Neutron and other particle radiation in the risk management process. And also, the risks associated with Electromagnetic radiation, Infrared Radiation and Ultraviolet Radiation apart from those that are produced by lasers shall be considered in Risk management process by the manufacturer.


Now I hope you have acquired some knowledge about IEC 60601-1 Clause 10: Protection against Unwanted and Excessive Radiation Hazards. 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!