Wednesday, March 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 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.

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Wednesday, March 16, 2022

IEC 60601-1 General Requirements for Testing Medical Electrical Equipment

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

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 5: General Requirements for Testing Medical Electrical Equipment as per IEC 60601-1.

Let's get into the topic.

Clause 5: General Requirements for

Testing Medical Electrical Equipment

Clause 5 of IEC 60601-1 states the general requirements for testing the Medical Electrical Equipment. The following are the Sub-Clauses.

5.1 Type Tests.

5.2 Number of Samples.

5.3 Ambient Temperature, Humidity and Atmospheric Pressure.

5.4 Other Conditions.

5.5 Supply Voltages, Type of current, Nature of Supply, Frequency.

5.6 Repairs and Modifications.

5.7 Humidity Preconditioning Treatment.

5.8 Sequence of Tests.

5.9 Determination of Applied Parts and Accessible Parts.

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

Type Tests

All the Tests mentioned in IEC 60601-1 are called as Type Tests. The Tests which need to be performed are determined based on the requirements of Clause 4 General Requirements, specially based on the requirements of Clause 4.2 Risk Management Process for Medical Electrical Equipment and Medical Electrical Systems.

Ambient Temperature, Humidity and Atmospheric Pressure

Once the Medical Electrical Equipment to be tested has been set up for Normal Use (as per Clause 5.7 Humidity Pre-conditioning Treatment), tests need to be performed within the range of environmental conditions specified in the technical description. The Medical Electrical Equipment is shielded from other influences which might affect the validity of the tests. In cases when ambient temperatures cannot be maintained, the test conditions are to be consequently modified and the test results need to be adjusted accordingly.

Other Conditions

Important requirement of Clause 5 is that it requires testing to be conducted under the least-favorable operating conditions.

Supply Voltages, Type of current, Nature of Supply, Frequency

The Medical Electrical Equipment having a Mains Part intended to be connected with A.C. Supply Mains is only tested with A.C. at a rated frequency. In case of rated frequency range, the Medical Electrical Equipment needs to be tested at the least favorable frequency within that range. The Medical Electrical Equipment having a Mains Part intended to be connected with D.C. Supply Mains is only tested with D.C. The Influence of Polarity also needs to be considered. In case, the Medical Electrical Equipment are designed for both A.C. and D.C. or Internal and External Power Source, the tests are to be conducted at the least favorable voltage and nature of supply.

Humidity Preconditioning Treatment

Prior to the testing as per Clause 8.7.4 (Leakage Current and Patient Auxiliary Current) and Clause 8.8.3 (Dielectric Strength), the Medical Electrical Equipment shall undergo Humidity Preconditioning Treatment. The Medical Electrical Equipment parts which are influenced by the climatic conditions that are simulated by the test, will only undergo Humidity Preconditioning Treatment.

Determination of Applied and Accessible Parts

The Applied Parts can be identified by referencing the accompanying or supporting documents.

The Accessible Parts can be identified by testing the Medical Electrical Equipment using a Standard Test Finger. The Test Finger can be applied in a Straight or Bent position. Other ways to identify the Accessible Parts, is by testing the Medical Electrical Equipment opening by means of a Test Hook.

If the Conductive parts of actuating mechanisms of electrical controls are accessible after the removal of handles, knobs, levers, it is considered as Accessible Parts. Meanwhile if the handles, knobs, levers, are removable using a tool, then the Conductive Parts of actuating mechanisms are not considered Accessible Parts.

Now I hope you have acquired some knowledge about IEC 60601-1 Clause 5: General Requirements for Testing Medical Electrical Equipment. We will meet again with another valuable topic related to Biomedical Engineering, Medical Device, Healthcare.