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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 Clause 16: Medical Electrical Systems as per IEC 60601-1.

Let's get into the topic.

Clause 16: Medical Electrical Systems

Medical Electrical System means a combination of individual devices in which at least one of the devices must be a Medical Electrical Equipment.

Clause 16 of IEC 60601-1 states the requirements for Medical Electrical Systems. The following are the Sub-Clauses.

1. General requirements for the ME Systems

2. Accompanying documents of an ME Systems

3. Power Supply

4. Enclosures

5. Separation Devices

6. Leakage Currents

7. Protection against Mechanical Hazards

8. Interruption of the Power Supply to parts of an ME Systems

9. ME System Connections and Wiring

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

General requirements for the Medical Electrical Systems

The Medical Electrical System shall not result in any unacceptable risk, after installation or further modifications. Only Hazards arising from combining of individual devices to a Medical Electrical System shall be considered. The Medical Electrical Equipment having only Basic Insulation as a protection against electric shock shall not be used in Medical Electrical Systems

Accompanying Documents

The Medical Electrical System shall be accompanied by supporting documents which includes all the information’s required to use the Medical Electrical System as prescribed by the manufacturer.

The accompanying documents shall also include the address of the manufacturer to which the responsible organization can refer.

Power Supply

If the Medical Electrical Equipment receives power from other equipment in the Medical Electrical System, the IFU shall specify the details of the other equipment to satisfy the requirement of IEC 60601-1.

Separation Devices

When the allowable value of Leakage current exceeds due to the functional connection between the Medical Electrical Equipment and other items in the Medical Electrical System, the separation device shall be applied as a safety measure. The Separation device shall have a dielectric strength, creepage distance and air clearance to provide one means of operator protection and withstand the highest voltage occurring across the separation device.

Leakage Current

The Patient Leakage current from patient connection to earth, under normal condition shall not exceed 10 mA dc and 100 mA ac for Type B and BF Applied Part & 10 mA dc and 10 mA ac for Type CF Applied Part. The Total Patient Leakage current with the same types of applied parts connected together, under normal condition shall not exceed 50 mA dc and 500 mA ac for Type B and BF Applied Part & 50 mA dc and 50 mA ac for Type CF Applied Part.

Measurements

The Touch current, Patient Leakage current, Total Patient leakage current and Total Earth Leakage Current are measured once the Medical Electrical System is brought up to the level Operating Temperature.

Medical Electrical System Connections and Wiring

The Pneumatic, electrical, hydraulic, and gas connection terminals and connectors shall be designed and constructed in such a way to prevent the incorrect connection to the nearby accessible connectors and removal of the connections without the use of a tool. Patient leads shall be designed in a way that it cannot be connected to other outlets present in the same Medical Electrical System which are meant to be in the patient environment.

Protective Earth Connections shall be made in a way that the removal of any single item of equipment in the Medical Electrical System shall not interrupt the protective earthing of any other part of the Medical Electrical System.

Now I hope you have acquired some knowledge about IEC 60601-1 Clause 16: Medical Electrical 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.

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