Earthing of moving parts, designing tips

#1
Hi everyone,
We are a small company developing a medical device, our device is class I, meaning the metallic parts of the device are protectively earthed.
However our device have a metallic drawer that would allow the surgeon to put instrumentation on it, what would you suggest regarding the earthing of this moving part ? Will we be able to have 0.1 Ohm from the drawer to the ground pin through all the metallic connections in between ?
Thank you for your answers
 
Elsmar Forum Sponsor

Benjamin Weber

Trusted Information Resource
#2
A device with protection class I is not required to have all metal parts protectively earthed. This is a very commom misunderstanding. You can have class I device with metallics parts not earthed. But as soon as you have at least one part that is connected to protective earth for dafety reasons it becomes class I. All parts in a class I device which are not protectively earthed shall be separated from potential hazardous live voltages by two means of protection, i.e. double or reinforced insulation.

In your particular case: Moving parts can be earhted according to 60601. But in this case you have to provide objective evidence, that the performance over the whole lifetime will not drop. There are so caled drag chains, that protect the conductor from being jammed adn which limit the mimumim bending radius. This might be a solution, but it is maybe a little to much for a "simple" drawer.

If you don't see a proper and reliable solution to connect the drawer to the PE, think about isolating it accordingly to achieve the required two means of protection.
 
Thread starter Similar threads Forum Replies Date
N Protective Earthing of Medical Device Moving Parts IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
F Earthing system (IT, TT or TN) and IEC 60601 Requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
J Protective Earthing for Medical Device with two wire power cord in metal enclosure IEC 60601 - Medical Electrical Equipment Safety Standards Series 9
A Quality's Authority - Company Moving In ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
B Cl. 9.2 - Moving parts - Applicable only to machinery? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
D Quality plan for moving locations ISO 13485:2016 - Medical Device Quality Management Systems 3
qualprod What do CB´s change when doing a partial moving ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
S How MR (Moving Range) in Z-MR chart is calculated Using Minitab Software 5
A Moving and positioning of patient - Mechanical hazard IEC 60601 - Medical Electrical Equipment Safety Standards Series 18
D Company Moving - Relabelling Question Medical Device and FDA Regulations and Standards News 0
Jen Kirley Moving on - I accepted an offer to be a Supplier Quality Engineer at GE Healthcare Coffee Break and Water Cooler Discussions 42
S Moving from client-server to cloud-based, is that a new submission? Medical Information Technology, Medical Software and Health Informatics 3
M How to calculate benefits? Moving some developed non controlled software/automation systems Service Industry Specific Topics 2
Ed Panek Moving from Contract Manufacturing to Production In-House ISO 13485:2016 - Medical Device Quality Management Systems 3
supadrai What to expect when moving to higher-risk medical devices? Other Medical Device and Orthopedic Related Topics 1
F It is acceptable moving remote locations staff to manufacturing plant for auditing? IATF 16949 - Automotive Quality Systems Standard 3
N How is documentation affected moving to an electronic system? ISO 13485:2016 - Medical Device Quality Management Systems 13
L Moving from ProArc to IFS Document Management Document Control Systems, Procedures, Forms and Templates 1
K Sister Company Moving to AS - First time "consultant" - Help? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 17
I Moving into Clinical Trials and need to find GMP Suppliers 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
B Moving (Transition) From ISO 14001:2004 to ISO 14001:2015 ISO 14001:2015 Specific Discussions 3
P Moving from a Paper based Quality System to an Electronic Quality System Manufacturing and Related Processes 14
S Validation requirement after moving labeling data base to different drive Software Quality Assurance 7
Q REACH due dilligence and meeting the ever moving SVHC target RoHS, REACH, ELV, IMDS and Restricted Substances 5
C Moving to a different Notified Body Quality Manager and Management Related Issues 5
R What Documentation is done by QA in FMCG (Fast Moving Consumer Goods) Misc. Quality Assurance and Business Systems Related Topics 2
T Risk Analysis for moving manufacturing equipment ISO 14971 - Medical Device Risk Management 17
C ISO9001: Moving from site certification to corporate certification Quality Manager and Management Related Issues 9
T Moving a Calibration/Test Laboratory to a new Location General Measurement Device and Calibration Topics 5
R Moving from ISO 9001 to AS9120A Document Control Systems, Procedures, Forms and Templates 2
Q Moving steps from ISO 9001 to TL 9000 TL 9000 Telecommunications Standard and QuEST 4
M SPC, Moving Range Chart and Weighted Graph Basic Questions Statistical Analysis Tools, Techniques and SPC 1
F Moving our Distribution Company - ISO 9001 Certification Impact ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
N NCR and CAPA in the FMCG (Fast Moving Consumer Goods) Industry Nonconformance and Corrective Action 1
D A2LA Certification and moving to a new Facility General Measurement Device and Calibration Topics 6
S Moving to a New Company for a New Position Coffee Break and Water Cooler Discussions 3
D IMR (Individuals and Moving Range) Chart for Short-Run SPC - How much data to include Statistical Analysis Tools, Techniques and SPC 1
S Validation and Qualification when moving to another Facility Qualification and Validation (including 21 CFR Part 11) 2
L Moving SPC Data from Variables to an Attributes Chart Statistical Analysis Tools, Techniques and SPC 4
S Advice on moving QMS Documents and Maintaining Revision History Quality Manager and Management Related Issues 9
N Requirements when moving locations - Class 1 Medical Device Manufacturer in the US Other Medical Device Regulations World-Wide 4
D AS9100 Shop Moving to a New Location AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
C Moving On Coffee Break and Water Cooler Discussions 12
C Test Correlation - Moving Test Equipment to a New Location Manufacturing and Related Processes 7
W Moving M&TE (Measuring & Test Equipment) to New Facility General Measurement Device and Calibration Topics 3
E Moving Window Test - Is this test about determining the Threshold Voltage? Quality Tools, Improvement and Analysis 2
D Moving Manufacturing Equipment from USA to Europe - Is CE certification required?? CE Marking (Conformité Européene) / CB Scheme 12
R Moving to an Electronic System - Quality System Software Recommendations ISO 13485:2016 - Medical Device Quality Management Systems 5
S ISO 13485 - Moving towards common (single) certification for multiple locations ISO 13485:2016 - Medical Device Quality Management Systems 13
R Preventative Maintenance - Moving to a Predictive Maintenance Program Manufacturing and Related Processes 10

Similar threads

Top Bottom