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Leakage Current Testing 102 • Brief review of the Leakage Current Test • General Patient Leakage Current • Patient Auxiliary Leakage Current • Mains on Applied Park Leakage Testing • Medical Device Leakage Testing Considerations

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Page 1: Leakage Current Testing 102 - Associated Research · 2 –IEC 60601-1 3rd edition: Medical Electrical Equipment Leakage Current Types Patient Leakage Current Patient Auxiliary Current

Leakage Current Testing 102

• Brief review of the Leakage Current Test

• General Patient Leakage Current

• Patient Auxiliary Leakage Current

• Mains on Applied Park Leakage Testing

• Medical Device Leakage Testing Considerations

Page 2: Leakage Current Testing 102 - Associated Research · 2 –IEC 60601-1 3rd edition: Medical Electrical Equipment Leakage Current Types Patient Leakage Current Patient Auxiliary Current
Page 3: Leakage Current Testing 102 - Associated Research · 2 –IEC 60601-1 3rd edition: Medical Electrical Equipment Leakage Current Types Patient Leakage Current Patient Auxiliary Current

Webinar Notes

Please use the Q & A utility to ask us any questions concerning the material being presented.

You can find a recording of this webinar and presentation on our Webinar Archive page, www.arisafety.com/webinars/archived-webinars/

Please contact Amanda Boothe– on the chat line or email [email protected] if you have any connection issues.

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Page 4: Leakage Current Testing 102 - Associated Research · 2 –IEC 60601-1 3rd edition: Medical Electrical Equipment Leakage Current Types Patient Leakage Current Patient Auxiliary Current

Touch Current

Leakage Current

IEC 60601-1

• IEC 60601-1 3rd Edition and the leakage current tests•Tests called out for in the standard

Learning Objectives

• Touch Current• Patient Leakage• Patient Auxiliary Leakage• Mains on Applied Part Leakage.

• Description• Network and MD

TestingExamples

• IEC 60601-1 discussion and reference diagrams•Leakage testing video examples

Page 5: Leakage Current Testing 102 - Associated Research · 2 –IEC 60601-1 3rd edition: Medical Electrical Equipment Leakage Current Types Patient Leakage Current Patient Auxiliary Current

1 – IEC 60990 2nd edition: Methods of Measurement of Touch Current and Protective Conductor Current2 – IEC 60601-1 3rd edition: Medical Electrical Equipment

Leakage Current Types

Patient Leakage Current

Patient Auxiliary Current

Current flowing in the patient in normal use between any patient connection and all other patient connections (and not intended to produce a physiological effect)2.

• Electric current through a human body when it touches one or more accessible parts of an installation or surface of electrical equipment1

• Also called Enclosure Leakage Current.

• Current flowing from the patient connections via the patient to earth • Current originating from the unintended appearance of a voltage from an external

source on the patient and flowing from the patient via the patient connections of an F-Type applied part to earth.

Mains on Applied

Part

Application of mains voltage on an applied part or patient lead.

Leakage Current Types

Page 6: Leakage Current Testing 102 - Associated Research · 2 –IEC 60601-1 3rd edition: Medical Electrical Equipment Leakage Current Types Patient Leakage Current Patient Auxiliary Current

Patient Leads

F-Type: APPLIED PART in which the PATIENT CONNECTIONS are isolated from other parts of the ME EQUIPMENT

Type BF: F-TYPE APPLIED PART provide a higher degree of protection

against electric shock than that provided by TYPE B APPLIED PARTS

Type CF: F-TYPE APPLIED PART provide a highest degree of protection against electric shock than that

provided by TYPE BF APPLIED PARTS

B Type: APPLIED PART that provides protection against

electric shock

Patient Lead Types

IEC 60601-1 3rd edition: Medical Electrical Equipment

Page 7: Leakage Current Testing 102 - Associated Research · 2 –IEC 60601-1 3rd edition: Medical Electrical Equipment Leakage Current Types Patient Leakage Current Patient Auxiliary Current

THE MAIN QUESTION TO ASKWhat is the severity of electric current someone would be exposed to if they were to touch the DUT under such conditions?

Normal and Single Fault Conditions

Measurements taken under normal conditions.Measurements also taken under single fault conditions to simulate worst case scenarios

Body Impedance

MD is designed to simulate the impedance of the human body under various conditions.

MD

Leakage current is measured through a human body impedance network, also known as a Measuring Device (MD)

How Is It Measured?

Page 8: Leakage Current Testing 102 - Associated Research · 2 –IEC 60601-1 3rd edition: Medical Electrical Equipment Leakage Current Types Patient Leakage Current Patient Auxiliary Current

Medical Devices IT Equipment

Electric Spas

How Is It Measured?

MD will vary by product standard. Most MDs are derived from IEC 60990-1

Page 9: Leakage Current Testing 102 - Associated Research · 2 –IEC 60601-1 3rd edition: Medical Electrical Equipment Leakage Current Types Patient Leakage Current Patient Auxiliary Current
Page 10: Leakage Current Testing 102 - Associated Research · 2 –IEC 60601-1 3rd edition: Medical Electrical Equipment Leakage Current Types Patient Leakage Current Patient Auxiliary Current
Page 11: Leakage Current Testing 102 - Associated Research · 2 –IEC 60601-1 3rd edition: Medical Electrical Equipment Leakage Current Types Patient Leakage Current Patient Auxiliary Current
Page 12: Leakage Current Testing 102 - Associated Research · 2 –IEC 60601-1 3rd edition: Medical Electrical Equipment Leakage Current Types Patient Leakage Current Patient Auxiliary Current
Page 13: Leakage Current Testing 102 - Associated Research · 2 –IEC 60601-1 3rd edition: Medical Electrical Equipment Leakage Current Types Patient Leakage Current Patient Auxiliary Current
Page 14: Leakage Current Testing 102 - Associated Research · 2 –IEC 60601-1 3rd edition: Medical Electrical Equipment Leakage Current Types Patient Leakage Current Patient Auxiliary Current
Page 15: Leakage Current Testing 102 - Associated Research · 2 –IEC 60601-1 3rd edition: Medical Electrical Equipment Leakage Current Types Patient Leakage Current Patient Auxiliary Current

Poll QuestionQuestion Goes Here

A. Answer Choice AB. Answer Choice BC. Answer Choice C D. Answer Choice D

Page 16: Leakage Current Testing 102 - Associated Research · 2 –IEC 60601-1 3rd edition: Medical Electrical Equipment Leakage Current Types Patient Leakage Current Patient Auxiliary Current

IEC 60601-1 Medical Equipment

Page 17: Leakage Current Testing 102 - Associated Research · 2 –IEC 60601-1 3rd edition: Medical Electrical Equipment Leakage Current Types Patient Leakage Current Patient Auxiliary Current

Patient Leakage Current

Page 18: Leakage Current Testing 102 - Associated Research · 2 –IEC 60601-1 3rd edition: Medical Electrical Equipment Leakage Current Types Patient Leakage Current Patient Auxiliary Current

Patient Leakage Current

Page 19: Leakage Current Testing 102 - Associated Research · 2 –IEC 60601-1 3rd edition: Medical Electrical Equipment Leakage Current Types Patient Leakage Current Patient Auxiliary Current

60601-1 – Figure 14

Touch Current

Page 20: Leakage Current Testing 102 - Associated Research · 2 –IEC 60601-1 3rd edition: Medical Electrical Equipment Leakage Current Types Patient Leakage Current Patient Auxiliary Current

60601-1 – Figure 15

Touch Current

Page 21: Leakage Current Testing 102 - Associated Research · 2 –IEC 60601-1 3rd edition: Medical Electrical Equipment Leakage Current Types Patient Leakage Current Patient Auxiliary Current

Video Demonstration

Page 22: Leakage Current Testing 102 - Associated Research · 2 –IEC 60601-1 3rd edition: Medical Electrical Equipment Leakage Current Types Patient Leakage Current Patient Auxiliary Current

Patient Auxiliary Current

Page 23: Leakage Current Testing 102 - Associated Research · 2 –IEC 60601-1 3rd edition: Medical Electrical Equipment Leakage Current Types Patient Leakage Current Patient Auxiliary Current

Mains on Applied Part

Page 24: Leakage Current Testing 102 - Associated Research · 2 –IEC 60601-1 3rd edition: Medical Electrical Equipment Leakage Current Types Patient Leakage Current Patient Auxiliary Current

Poll QuestionQuestion Goes Here

A. Answer Choice AB. Answer Choice BC. Answer Choice C D. Answer Choice D

Page 25: Leakage Current Testing 102 - Associated Research · 2 –IEC 60601-1 3rd edition: Medical Electrical Equipment Leakage Current Types Patient Leakage Current Patient Auxiliary Current

Leakage current

External voltage on SIOFigure 17

External voltage on metal accessible part

that is not PEFigure 18

Mains Voltage on Applied Part

Figure 16

Additional Tests and Considerations

Page 26: Leakage Current Testing 102 - Associated Research · 2 –IEC 60601-1 3rd edition: Medical Electrical Equipment Leakage Current Types Patient Leakage Current Patient Auxiliary Current

Visit us online to view all of our Educational Resourcesarisafety.com/support/educational-resources/

Educational Resources

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Page 27: Leakage Current Testing 102 - Associated Research · 2 –IEC 60601-1 3rd edition: Medical Electrical Equipment Leakage Current Types Patient Leakage Current Patient Auxiliary Current
Page 28: Leakage Current Testing 102 - Associated Research · 2 –IEC 60601-1 3rd edition: Medical Electrical Equipment Leakage Current Types Patient Leakage Current Patient Auxiliary Current

You can find a recording of this webinar and presentation on our Webinar Archive page, arisafety.com/webinars/archived-webinars/

Check out our website for more information arisafety.com

For any questions about our webinars send an email to Amanda at [email protected]

Contact Us

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