SBS - The best value in QMS software

Can I use varistor on medical devices?

M

MSouza

#1
My concern is about 8.11.1 h) that says:

h) * ME EQUIPMENT shall not include a device that causes disconnection of the ME EQUIPMENT from the SUPPLY MAINS by producing a short circuit that results in operation of an overcurrent protection device.

So, varistor is prohibited to use on supply mains??

Thanks!
 
Elsmar Forum Sponsor

Peter Selvey

Staff member
Moderator
#2
They should not be used.

There is some history of fire for varistors, but I think the primary reason is that placing a short on the mains could cause not only the medical device in question to stop operating, but could potentially trip out the room breaker which could have significant implications in a medical environment.

Actually I just read the rationale, it says the same thing. If the clause has an "*" mark, it means there is an explanation in Annex A.
 
M

MSouza

#3
Tanks Peter! Thats what I thought, but one lab here in Brazil thinks different. They say to me that I can use varistors after the fuse.

I will maintain my project as is, without varistor.
 
N

nikolaos

#4
Varistors can be used after the fuses. Without a varistor between L/N the EMC Surge test will be most probably fail. Transient surges can cause fire, short-circuits...in a ME. A Varistor is a protection against this. Varistors can be destroyed by too many surges so the probability of a short-circuited varistor is very low. From my experiance Testing Labs accept the presence of varistors.
 
M

MSouza

#5
Nikolaos, tank you for your coment, I'm already certified a product with a off the shelf medical power supply that came with no varistors on mains input, passed with no problems on EMC surge tests.
But good to know that possibility.


Tanks!
 
#6
Varistors in the mains part have been identified as an "unaddressed safety aspect" in edition 3. Guidance on this is provided in IEC TR 60601-4-3:2015 at clause 3.2.168 (I only have the preview so cannot say what the guidance is!).

Link:
https://webstore.iec.ch/publication/22123

IEC TR 60601-4-3:2015
Medical electrical equipment - Part 4-3: Guidance and interpretation - Considerations of unaddressed safety aspects in the third edition of IEC 60601-1 and proposals for new requirements
 
Thread starter Similar threads Forum Replies Date
M (medical device) V&V phase: justification of acceptance criteria (statistical method ?) Design and Development of Products and Processes 0
E Medical Device - CE marking - Local market notifications EU Medical Device Regulations 1
S Medical Device Registration in Qatar Other Medical Device Regulations World-Wide 1
B Specialized Medical Apparel Manufacturing and Related Processes 1
B Free Sales Certificate for Non Medical Devices Other Medical Device Related Standards 1
M Medical device substance based-leachables Other Medical Device Related Standards 1
K Usability for custom made medical devices IEC 62366 - Medical Device Usability Engineering 4
P Anyone have an Idea on UAE Medical device registeration- Class B with FDA only Other Medical Device Regulations World-Wide 0
F Mobile app regulations - Class II medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M What are the basics of Medical Device Single Audit Program (MDSAP)? ISO 13485:2016 - Medical Device Quality Management Systems 7
dgrainger Informational MHRA - Regulating medical devices in the UK - Post Brexit - 2021-02 UK Medical Device Regulations 0
U Medical Device CE Marking - Using a disposable bearing CE Marking (Conformité Européene) / CB Scheme 3
L Medical Device Registration in Macau Other US Medical Device Regulations 1
A Medical Device Registration in the Dominican Republic Other Medical Device Regulations World-Wide 4
Aymaneh Medical Device Cybersecurity Risk Management IEC 27001 - Information Security Management Systems (ISMS) 2
S Medical watch Class II (AP Type CF) with USB connection IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
T B2C Medical Device Shipping across the US Other Medical Device Related Standards 0
M Medical Device Registration In Malaysia Other Medical Device Regulations World-Wide 2
N Adding unclassified product to the medical device registration US Food and Drug Administration (FDA) 1
V Sister companies selling same medical device under different names ISO 13485:2016 - Medical Device Quality Management Systems 3
K CE Marking for Class I Medical Device? CE Marking (Conformité Européene) / CB Scheme 7
L Medical device storage conditions ISO 13485:2016 - Medical Device Quality Management Systems 1
F USB powered handheld medical device - Isolation requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
L How to determine / validate Medical Device Storage Conditions ISO 13485:2016 - Medical Device Quality Management Systems 1
M Europe GMP medical devices - Combination products - Ancillary medicinal substance CE Marking (Conformité Européene) / CB Scheme 4
L Shelf life of medical devices Other Medical Device Related Standards 4
P Best european location to set up for a virtual medical device manufacturer? EU Medical Device Regulations 4
Y Possibility for Medical Device registration in Israel Regulation Other Medical Device Regulations World-Wide 4
U Does *anyone* know a lab that will test to EN 455-4 Medical Gloves shelf life determination? EU Medical Device Regulations 1
R Classification of USB DC operated medical equipment IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
M Medical Devices - Ancillary - ISO 10993-17 Medical Device and FDA Regulations and Standards News 6
S How is the service life for class I reusable medical devices described in MDR? EU Medical Device Regulations 7
S How is the service life described for class I reusable medical devices in MDR? Elsmar Xenforo Forum Software Instructions and Help 1
M How does IEC-60601-1 apply to a non-medical device in the patient vicinity? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
M Determining if an Insulin Pen Testing Machine is a Medical Device? EU Medical Device Regulations 4
M Indian Medical Device Rules - Manufacturing and Wholesale Lic. Required ? Other Medical Device Regulations World-Wide 3
K Medical Device Repairs and ISO Scope ISO 13485:2016 - Medical Device Quality Management Systems 3
R Manufacturing plants relocation - Medical Device Medical Device and FDA Regulations and Standards News 7
R Medical Device - Change manufacturing plant Design and Development of Products and Processes 6
M Brexit The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 UK Medical Device Regulations 1
P New Global HQ Suggestions for Virtual manufacturing/own brand labelling of medical devices? EU Medical Device Regulations 0
shimonv Classification of a cloud- base viewer for the output from a medical device US Food and Drug Administration (FDA) 7
A FDA guidance on non-sterile Medical Device Packaging Medical Device and FDA Regulations and Standards News 6
N Chemical Testing on Medical Devices - Solutions in a container closure system (bag) EU Medical Device Regulations 1
M Is IEC 60601-1-2 required by FDA for all electronic medical devices? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
A Medical device Mode Of Action CE Marking (Conformité Européene) / CB Scheme 2
P Best Global Option to become an OBL/PLM/Virtual medical device brand in 2020 Other Medical Device Regulations World-Wide 2
rob73 UK Medical Device Regulations Forum - UK MDR Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 3
S Philippines CMDL (Certificate of Medical Device Listing) Elsmar Cove Forum ToS and Forum Policies 0
M Subcontracting a repair of Medical Devices Canada Medical Device Regulations 0

Similar threads

Top Bottom