Saturday, April 30, 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 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.

Conditions for application to Medical Electrical Equipment or Medical Electrical Systems.
Risk Management Process for Medical Electrical Equipment or Medical Electrical Systems.
Essential Performance.
Expected Service Life.
Alternative Risk Control measures or test methods for Medical Electrical Equipment or Medical Electrical Systems.
Medical Electrical Equipment or Medical Electrical System parts that contact the Patient.
Single Fault Condition for Medical Electrical Equipment.
Components of Medical Electrical Equipment.
Use of Components with High-Integrity Characteristics in Medical Electrical Equipment.
Power supply.
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.

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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.

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.