Protective Earthing for Medical Device with two wire power cord in metal enclosure

J

jayanthi

#1
hi
how to provide protective earthing for a medical device with two wire power cord with metal enclosure?
 
Elsmar Forum Sponsor

Marcelo

Inactive Registered Visitor
#2
Re: Protective Earthing for Medical Device with two wire power cord in metal enclosur

I´m not sure i understand the question...

You are a manufacturer and wants to provide protective earthing in the devide you are designing?

If you need protective earthing in your device (meaning, if your devide has onlu basic separation between 'live' parts and the enclosure and you need protective earthing to make the two layers of protection needed), you need a three wire power cord, the protective earthing is the "third pin".
 
M

MIREGMGR

#3
Re: Protective Earthing for Medical Device with two wire power cord in metal enclosur

There are a number of technical reasons why a "simple" connection to earth-ground from the conductive chassis/enclosure of an electrically powered product, separate from the electrical path of the power cord, is no longer considered an adequate way of achieving better electrical safety.
 

somashekar

Staff member
Super Moderator
#4
Re: Protective Earthing for Medical Device with two wire power cord in metal enclosur

hi
how to provide protective earthing for a medical device with two wire power cord with metal enclosure?
By a design change.
Incorporate a 3 pin inlet socket and connect the ground pin to your chassis / common ground / metal enclosure. Provide 3 pin power cord for use.
 

Marcelo

Inactive Registered Visitor
#6
Re: Protective Earthing for Medical Device with two wire power cord in metal enclosur

Quote:
Originally Posted by jayanthi View Post

hi
how to provide protective earthing for a medical device with two wire power cord with metal enclosure?
With a twin chord wire? Unless you adopt 'double insulation' such as in most electrical tools.
Just a clarification - double insulatin does not use protective earthing.

IEC standards require generally require two levels of protection:

- in the case of class I devices, protection is provided by basic insulation (1 level) + protective earthing (1 level)

- in the case of classe II devices, protection is provided by double insulation (two levels), but the device cannot have protective earthing in this case, it can only have functional earthing (int the case of a classe II device with a 3-wire cord).
 
J

jayanthi

#8
Re: Protective Earthing for Medical Device with two wire power cord in metal enclosur

Hi Friends
Thanks everybody for your reply.
Actually we are medical device manufacturer and going for EMC testing. In this regard i need to clarify myself in following things.

Device is battery backup with an AC adapter( 2 wire). Through AC adapter , the battery unit will be charged and provide supply to the unit in case of power failure
1.how to provide ground path? is it necessary ? or DC ground is sufficent
2. whether need to connect chassis to Dc ground .Whether it can withstand ESD test .
3.we have to use 3 wire to connect chassis?

Thanks in advance for any help
 
P

PaulGr

#9
Re: Protective Earthing for Medical Device with two wire power cord in metal enclosur

Hi,

For me, your setup is not completely clear. Maybe these questions can help:
- Is your AC adapter an independant enclosure? Metal or plastic? What information is on the type label? And does it comply with any standards?
- Is the AC input of the adapter 2-wire or the DC output?
- Will the medical device be used when the AC adapter is connected?
 
J

jayanthi

#10
Re: Protective Earthing for Medical Device with two wire power cord in metal enclosur

Paul
I thnik below points will clear you doubts
1. AC adapter is independent wiht platic enclosure with CE, U/L listed E127643 marks
2. Its two wire with Dc ouput 12V.
3. ya sometimes device will be used with adapter connected
 
Thread starter Similar threads Forum Replies Date
N Protective Earthing of Medical Device Moving Parts IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
W Protective earth for Class I ME equipment IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
J Secondary circuits and protective earth IEC 60601 - Medical Electrical Equipment Safety Standards Series 11
G IEC 61010 - Single Fault Condition - Protective Impedance Implementation IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
J Can the shield of a cable be used as a protective bonding conductor? Design and Development of Products and Processes 2
N Accelerated Aging Test for Disposable Protective Garment for Incontinence Other US Medical Device Regulations 1
U Protective vs. Functional Earth Differences IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
R Is protective earth connection regarded as a part of the applied part? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
A Medical Device Protective Earth (PE) issues IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
A Minimum Testing Requirements for a Clear Protective Equipment Barrier (Class II 510K) Other US Medical Device Regulations 1
R How much Protective Current Rating of Building Branch Circuit should be considered? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
R How to Design a Protective System for Infusion Pump IEC 60601 - Medical Electrical Equipment Safety Standards Series 48
R What is the meaning of "Highest RATED Current" in Protective Earth Impedance Test? IEC 60601 - Medical Electrical Equipment Safety Standards Series 8
S How to overload a linear transformer with multiple protective devices IEC 60601 - Medical Electrical Equipment Safety Standards Series 12
S Protective Earth Test in IEC 60601 IEC 60601 - Medical Electrical Equipment Safety Standards Series 9
A Essential Requirements Checklist for PPE (Personal Protective Equipment) CE Marking (Conformité Européene) / CB Scheme 6
G ASTM b137 - Is protective value equal to protective capability? Various Other Specifications, Standards, and related Requirements 3
Z Packaging and shipping of multiple PWBA/PCBAs in one ESD protective bag Supplier Quality Assurance and other Supplier Issues 5
B Allergic reactions complaints for a protective apparel (impervious gown) Customer Complaints 4
A Maintaining traceability through our manufacturing process - Protective suits - 110 Misc. Quality Assurance and Business Systems Related Topics 1
S Earthing of moving parts, designing tips IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
F Earthing system (IT, TT or TN) and IEC 60601 Requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
A Canadian Safety Labels for medical electrical equipment Canada Medical Device Regulations 0
A Applicability of Photobiological Safety Evaluation for LED used in medical devices Reliability Analysis - Predictions, Testing and Standards 1
M Medical device certificate in Australia - ARTG certificate Other Medical Device Regulations World-Wide 0
Q Software as a medical device vs software not sold as medical device: local regulations for sale? EU Medical Device Regulations 4
H Medical device Product Registration Registrars and Notified Bodies 2
T Google Fit Health datas and Medical devices Application Medical Information Technology, Medical Software and Health Informatics 0
A Can a power Supply be an accessory to a medical device, if it is an 'off-the-shelf' product. IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
B Procedure packs with non-medical devices EU Medical Device Regulations 1
A Medical device labelling Date of manufacture US Food and Drug Administration (FDA) 2
W Non Sterile Medical Device Environmental Tests Other Medical Device Related Standards 4
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
A Clinical assessment sample size - Medical device Class IIb implantable (93/42 directive) EU Medical Device Regulations 2
K 25-year lifetime of medical device - document storage period EU Medical Device Regulations 1
K Relabeling an existing medical device in the field? Other US Medical Device Regulations 6
J Should a Class 1 medical device with an option to measure body weight be considered Class 1m? EU Medical Device Regulations 0
A Reliable sources for following EU medical device regulatory EU Medical Device Regulations 0
T IVDR Medical device software CE Marking (Conformité Européene) / CB Scheme 8
A Customer Approval (Medical Devices) Document Control Systems, Procedures, Forms and Templates 4
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
J Requirements as a Distributor for Incoming Inspection of Purchased Finished Medical Device Medical Device Related Regulations 0
S Microwave medical waste disinfectant - A medical device or not? Other ISO and International Standards and European Regulations 3
S Registration of Medical Device in Hong Kong - labeling requirements Other Medical Device Regulations World-Wide 0
D Electrical Medical Devices class I EU Medical Device Regulations 0
J Are complaints applicable to development of medical devices? Customer Complaints 2
V Software as medical device (SaMD) replicated for multiple clients through APIs IEC 62304 - Medical Device Software Life Cycle Processes 5
M Is the output of a device a Medical Device? IEC 62304 - Medical Device Software Life Cycle Processes 5
P Do we need to retrospectively use the "MD" symbol (indicating device is a medical device) on labels, e.g. finished devices within expiration date? EU Medical Device Regulations 2
M Do I need separation in my circuit with a medical charger? IEC 60601 - Medical Electrical Equipment Safety Standards Series 0

Similar threads

Top Bottom