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 8.10: Components and Wiring as per IEC 60601-1.

Let’s get into the topic.

Sub Clause 8.10: Components and Wiring

The Sub Clause 8.10 of IEC 60601-1 states the requirements for Components and Wiring. It is further classified as following.

Fixing of Components

Fixing of Wiring

Connections between different parts of Medical Electrical Equipment

Cord Connected Hand-Held parts & Cord Connected foot operated control devices

Mechanical Protection of Wiring

Guiding rollers for Insulated Conductors

Insulation of Internal Wiring

Let’s discuss in detail about the important requirements of above-mentioned Classifications.

Fixing of Components:

The Components of Medical Electrical shall be mounted securely to prevent the unwanted movement that could result in an unacceptable risk.

Fixing of Wiring:

The Conductors and Connectors of Medical Electrical Equipment shall be secured and insulated. The accidental detachment of Conductors and Connectors shall not result in a Hazardous Situation.

Connections between different parts of Medical Electrical Equipment:

The Flexible Cords used for interconnection of different parts of Medical Electrical Equipment that are detachable without using the tool shall have a means of connection such that there is no compromise in the compliance of Metal Accessible Parts with the requirements of Clause 8.4 of IEC 60601-1 when a connection is loosened or broken due to the disengagement of one of the connecting means.

Cord Connected Hand-Held parts and Cord Connected foot operated control devices:

Only the Conductors and Components which are operating at the voltages not exceeding 42.4 Peak Voltage AC and 60 Voltage DC in circuits isolated from the Mains Part by Two Means of Protection shall be present in the Cord Connected Hand-Held and Foot Operated Control devices of the Medical Electrical Equipment and their associated connection cords.

Mechanical Protection of Wiring:

The Adequate protection shall be provided for Internal Cables and Wiring against contact with the moving part or from friction at sharp corners and edges.

The Wiring, cord forms or the components of Medical Electrical Equipment shall be designed such that there shall not be any damage during the opening and closing of access covers or during the assembly. Guiding rollers for Insulated Conductors:

In Medical Electrical Equipment, the Guiding rollers of insulated conductors shall be constructed in a such a manner that in Normal Use, the movable insulated conductors are not bent round a radius of less than 5 times the outer diameter of the concerned lead.

Insulation of Internal Wiring:

The Adequate protection shall be provided for the insulating sleeving present in the internal wiring of the Medical Electrical Equipment. The Sleeving which can be removed only by breaking or cutting shall be used to satisfy this requirement. The Sleeving that is secured at both ends shall also be used.

The Sheath of flexible cord present inside the Medical Electrical Equipment shall not be considered as a Means of Protection when it is exposed to thermal or mechanical stress outside of its rated characteristics.

During Normal Use, the Insulated Conductors of Medical Electrical Equipment shall experience a temperature exceeding 70 °C. So, the Insulated Conductors shall have an insulation of Heat Resistant Material because the deterioration of the insulation shall result in a Non-Compliance of the requirements of IEC 60601-1.

Now I hope you have acquired some knowledge about IEC 60601-1 Sub Clause 8.10: Components and Wiring. 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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