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 7.2: Markings on the outside of Medical Electrical Equipment as per IEC 60601-1.

Let’s get into the topic.

Marking on the outside of ME Equipment or ME Equipment parts:

Legibility & Durability:

The Markings on the Medical Electrical Equipment shall be clearly legible for the person viewing from the intended position of performing the related function.

The Markings on the Medical Electrical Equipment shall remain durable such that it can only be removed with the help of a tool or by applying an Appreciable force. The Markings shall be durable to remain clearly legible during the expected service life of the Medical Electrical Equipment.

Minimum Requirements:

If the size of Medical Electrical Equipment or its parts or its accessories does not allow provision for affixation of markings, then these markings shall be affixed in the accompanying documents or shall be affixed in the Individual packaging.

Identification:

The Medical Electrical Equipment, it’s detachable components or accessories shall have the markings about the Name or Trademark and the contact details of the Manufacturer, Model and Type reference, Serial Number, Batch or lot identifier, Date of Manufacture and use by date.

ME Equipment indented to receive power from other equipment:

If the Medical Electrical Equipment receives power from other equipment in the Medical Equipment system, then the compliance of IEC 60601-1 shall be dependent on the other equipment.

Connection to supply mains:

The Medical Electrical Equipment shall have markings about the Rated Supply Voltages or Voltage ranges to which it is connected. The Rated Voltage ranges shall have symbol hyphen (-) between the minimum and maximum voltages range. If the Medical Electrical Equipment uses Multiple Rates voltage ranges or Multiple supply voltages, then each shall be separated by symbol solidus (/).

Electrical Input power from the supply mains:

The Medical Electrical Equipment shall have markings about the Rated input voltages that it shall receive from the supply mains. The Rated input voltage shall be given in amperes or volt amperes or if the power factor exceeds 0.9 in amperes, volt amperes or watts.

Output Connectors:

The Medical Electrical Equipment with output connectors that intends to deliver power shall be marked with Rated current or power, output frequency, Rated output voltage.

Applied Parts:

The Medical Electrical Equipment’s applied parts shall be markings with respect to degree of protection against electrical shock, marked with relevant symbol. The relevant symbol shall be marked adjacent to the connector or on the connector for the applied part.

Mode of Operation:

If there is no marking with respect to Mode of Operation, then the Medical Electrical Equipment shall be considered as suitable for continuous operation. The Duty Cycle shall be marked with appropriate symbol showing Maximum Activation ON time & Deactivation OFF time for Medical Electrical Equipment having Non-Continuous Operation.

Fuses:

In case of fuse holder being an accessible part, type and full rating of the fuse shall be marked adjacent to fuse holder.

Cooling conditions and Protective Packaging:

The Medical Electrical Equipment’s requirements for cooling provisions shall be marked.

The special handling measures and permitted environmental conditions during transport and storage shall be marked outside the packaging.

Removal Protective Means:

In case, the alternate application of the Medical Electrical Equipment requires the removal of protective means, markings shall be made in the protective means to indicate the necessity for removal, when the function is no longer needed.

Now I hope you have acquired some knowledge about IEC 60601-1 Sub Clause 7.2: Markings on the outside 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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