Hi friends!!!

In our previous blogs, we have discussed about the following topics.

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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Functional Earth Terminal:

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

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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 Equipment. 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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