Potential Equalization Conductor vs Functional Earth Terminal

#1
I have a class I medical device with a metal chassis and a type BF applied part, where the power inlet ground wire is attached to the chassis.

My first question would be what is the difference between a Potential Equalization Conductor and a Functional Earth Terminal.

And second is the Potential Equalization Conductor required?
1601045336900.png
 
Elsmar Forum Sponsor

Ninja

Looking for Reality
Trusted Information Resource
#2
Howdy,

Not in medical, so only addressing one of the questions:

"potential equalization conductor: conductor other than a protective earth conductor or a neutral conductor, providing a direct connection between electrical equipment and the potential equalization busbar of the electrical installation"

From the IEC Glossary {emphasis added}.

I don't know about Medical, but in non-medical electronics, a separate "neutral" or "common" safety is required to avoid a backfeed voltage through the common wire. This goes from motor controllers all the way up through industrial building power supply.
Long and short, it's a separate safety mechanism to avoid shock.
 
#3
Hello Shanerock,
It's all about the purpose of the connection, for what I know :
  • PE (protective earth) = safety
  • FE (functional earth) = electomagnetic compliance and compatibility
  • Potential Equalization = safety purpose, found mostly in medical devices operating in the patient environment to minimize potential differences between devices and objects
Physically, PE and FE are found in the C14 connector, the potential equalization connector is separated and is supposed to be plugged by the service personel when using the device, it should be written in the Manual.
 

Peter Selvey

Staff member
Super Moderator
#4
Just to add, potential equalization is intended for "cardiac protected areas", where the heart might be exposed during surgery. Currents applied direct to the heart are about 1000 times more dangerous than to the body, or in other words very small currents, voltages are considered dangerous. As such, these areas usually have very low resistance bonding for all metal parts, and potential equalization for equipment in the area.

I think it can become a sales point (looks cool, also can pad out the device spec sheet) and it's cheap to add, so a lot of equipment has these terminals even though they are unlikely to be used in a cardiac area. They could also be useful in noise reduction, either if the equipment itself is noisy or is sensitive to noise. But that's not the original purpose.
 
Thread starter Similar threads Forum Replies Date
A Potential Equalization Conductors IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
G How to implement H&S and Quality Control Requirements in Contract for Potential Supplier? Contract Review Process 6
G Self Assessment Audit from a new potential customer General Auditing Discussions 3
MrTetris Should potential bugs be considered in software risk analysis? ISO 14971 - Medical Device Risk Management 5
T Potential Off-Label Use question 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
M Informational USFDA – Efforts to evaluate materials in medical devices to address potential safety questions Medical Device and FDA Regulations and Standards News 0
M Medical Device News TGA Consultation: Potential reclassification of active medical devices for diagnosis and patient therapy Medical Device and FDA Regulations and Standards News 0
M Medical Device News Letter to the health and care sector: update on preparations for a potential no-deal Brexit Medical Device and FDA Regulations and Standards News 0
G Options for failing a VDA POTENTIAL audit VDA Standards - Germany's Automotive Standards 2
S FMEA column column ''therblig motion'' for a given potential failure FMEA and Control Plans 12
M Should Potential Customer Complaint Outcome Define Registrar NC Rating? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
C Selecting potential internal auditors Internal Auditing 3
N PFMEA Potential Failure Mode for Weight FMEA and Control Plans 5
L "Potential" Essential Performance in IEC 60601-2-54 (Definition) IEC 60601 - Medical Electrical Equipment Safety Standards Series 9
kedarg6500 Potential Effects of Failure(s) FMEA and Control Plans 23
R Need Help on Analysis: How to know potential causality model from historical data Problem Solving, Root Cause Fault and Failure Analysis 5
J Potential Customers Asking for EIRs / 483s when evaluating a CRO for future work US Food and Drug Administration (FDA) 2
G ISO/TS 5.6.2.1 - Potential Field Failures on OEMs IATF 16949 - Automotive Quality Systems Standard 3
P TS 16949 Clause 5.6.2.1 - Review of Potential Field Failures IATF 16949 - Automotive Quality Systems Standard 16
J CRB (Certification Registration Body) Notification of Potential Escape AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
Marc LinkedIn Accused Of Secretly Selling Members Professional Data To Potential Employers World News 9
N Scouting Potential Suppliers - Strategy and Tactics Supplier Quality Assurance and other Supplier Issues 7
Colin Interesting Discussion Potential Issues for Auditing ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 84
B Providing a potential Customer with a Sample Medical Device in Brazil Other Medical Device Regulations World-Wide 1
Ron Rompen Wording of potential cause of failure in a PFMEA FMEA and Control Plans 8
F Supplier Quality Engineer Beginner - Potential Interview Questions Supplier Quality Assurance and other Supplier Issues 3
GURU SDI VDA 6.3 Hand Book - Two sections for Potential Analysis VDA Standards - Germany's Automotive Standards 1
H Identifying Potential Automotive Suppliers before Developing New Products Supplier Quality Assurance and other Supplier Issues 2
T Attribute (Check Fixtures) - Breaking the Ice with Potential Customers Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
P Lessons Learned Identification - Potential Preventive Action Responsibilities Preventive Action and Continuous Improvement 4
Hershal Metrology Careers - Potential good Paying Jobs in the Science of Measurement Field Career and Occupation Discussions 1
C List of Potential Hazards Definitions in Annex E of BS EN ISO 14971:2009 ISO 14971 - Medical Device Risk Management 4
Mikey324 Assessing Potential Field Failures (TS 16949 Requirements) Quality Manager and Management Related Issues 5
K Observation - Potential Nonconformity - How to address this Audit Finding? General Auditing Discussions 9
8 Introducing a Balance Line - Identifying potential future pitfalls etc. Lean in Manufacturing and Service Industries 2
M Analysis of Potential Field Failures - Impact on Quality, Safety or the Environment Management Review Meetings and related Processes 10
Q Potential Field Failure as Mgmt Review Input for TS16949: How to meet the clause? IATF 16949 - Automotive Quality Systems Standard 1
hogheavenfarm Potential Employer Questions Reason for Leaving Career and Occupation Discussions 37
B Mining Nonconformance Data for Potential Missed Audit Findings Misc. Quality Assurance and Business Systems Related Topics 2
M Correlation between 2 Variables - Potential X's that might affect yield percentage Quality Tools, Improvement and Analysis 5
M PFMEA (Process FMEA - Potential Causes and Failure) - Operator's Role FMEA and Control Plans 11
E Tips on how to notify customers (and potential ones) of ISO Certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
A Procedure to Identify Potential Emergency Situations and Accidents Miscellaneous Environmental Standards and EMS Related Discussions 4
S Should an auditor document potential nonconformities in the audit report? General Auditing Discussions 41
N Definition Nonconformity vs. Potential Nonconformity - Difference? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 3
automoto ISO TS 16949 Management Review Input - Potential Field Failures IATF 16949 - Automotive Quality Systems Standard 10
Chennaiite FMEA Severity Rating for Potential Manufacturing Effect mentioned in the FMEA manual FMEA and Control Plans 9
J Google Offers Peek at Operating System, a Potential Challenge to Windows After Work and Weekend Discussion Topics 2
J Sources of Potential Measurement Variation for Brinell Hardness Test Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
L ISO 17025 4.12: "...potential sources of nonconformities...shall be identified." ISO 17025 related Discussions 21

Similar threads

Top Bottom