User Replaceable Li (Lithium Ion) Battery in a Medical Device

H

haze001

#1
Greetings,

I'm working on a Class II handheld, Li-Ion battery powered medical device.

We expect to build it in the US and sell it worldwide.

I need some help understanding to which US and EU standards/regulations the battery needs to be tested. This is a single cell Li-Ion battery that includes overcharge/over-discharge safety circuitry.

I have received feedback from one battery supplier that if the battery is user replaceable, it will have to undergo testing to UL2054 independent of any testing done for the device and that if the battery is not user replaceable, its testing becomes part of the device system testing.

Is it true that separate battery testing is required? If so, to which standards should we test?
Does anyone have experience with what additional steps may be needed to certify a battery separate from its device?

Thanks for your help,

-Bryan
 
Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#2
Re: User replaceable Li Battery in a Medical Device

My understanding is that the battery will have to be certified to comply with UL2054 irrespective of being user-replaceable. Since it's in a medical device, it will have to pass the safety tests. (We just went through this on a device we were working on.) Hence, it's always better (easier) to get a listed battery if that's an option.

In addition to 2054, expect to have to do UN DOT 38.3 testing - if you want to ship your batteries (or devices containing batteries).

There's a considerable amount of information you have to gather from the battery manufacturing to support the testing so be prepared for a rather arduous process.
 
M

maple68

#3
Re: User replaceable Li Battery in a Medical Device

I have the same question for our handheld Class II device. We were told to use UL 2054 battery. I'm not sure if we can use UL 1642 Battery.

Thanks for your advice.
 
H

haze001

#4
Re: User replaceable Li Battery in a Medical Device

I have found a little more information since I began looking.

If the battery is embedded in the device (not user replaceable), it needs to meet UL-1642
If the battery is user replaceable, it needs to meet UL-2054
Because it is a medical device, the battery needs to meet IEC-62133

Testing centers can combine IEC 62133 and UL 2054 testing because there is some overlap in the testing requirements
UL testing requires 50-100 batteries and can take 12-20 weeks.

Hopefully someone who has been through the process will elaborate on this.
 
M

maple68

#5
Re: User replaceable Li Battery in a Medical Device

Thanks a lot, Haze001. This is helpful.

I had a bit different information from our medical device (IEC 60601-1) test Lab. they asked us to provide UL 2054 Certificate for battery. But we were told if we use battery cell, then UL 1642 + IEC 62133 certified battery is ok. I was confused by what is battery cell and what is battery pack. I'm try to search online.

For now, I think we will try to buy the battery from UL2054 certified and IEC 62133 tested manufacurer.

Thanks again,

Maple



Thanks again,
 
M

maple68

#6
Re: User replaceable Li Battery in a Medical Device

Just want to give a bit updates on our status.

We did find a battery went throught IEC 62133, UL 2054, and UN 38.3 and matches our specifications. So I think we are ok.

Thanks again for the help from Haze001.

Maple
 
B

Battery Bob

#7
Hi Maple,
Can you comment on the manufacturer and battery model number that you found? We're also searching for a non-user replaceable LiIon battery with built-in cell protection that complies with IEC62133.
 
M

maple68

#8
I can send further information in email. Please email me at tanyanrose (at) hotmail (dot) com.

Thanks,

Maple
 
Last edited by a moderator:
M

merat

#9
Can you please send me the information on the supplier of this battery which you found that is compliant with various standards?

Thanks.
 
Thread starter Similar threads Forum Replies Date
Brizilla User Profile - How do I edit my profile info? Elsmar Xenforo Forum Software Instructions and Help 3
T Documenting hazardous situations associated with user/patient population ISO 14971 - Medical Device Risk Management 3
A The refund of 510(k) user fee Medical Device and FDA Regulations and Standards News 0
A User interface Language Requirements - EU MDR EU Medical Device Regulations 1
S User evaluation for self monitoring blood glucose test systems US Food and Drug Administration (FDA) 4
P Equipment 21 CFR 820.70(g) - User Requirements Document for Off the shelf equipment 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
S Forced ServiceNow validation - No change in our current user and functional requirements IT (Information Technology) Service Management 4
D Software User Interface Languages for LVD and IVD CE Marking (Conformité Européene) / CB Scheme 2
Q User Requirement Specification for HR (Human Resource Management System) Manufacturing and Related Processes 1
P Electrosurgical Device User Need: Cord Flexibility -> Requirement Other Medical Device and Orthopedic Related Topics 4
S Recommendation for user friendly Gaga R&R and Cpk software Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 10
B ISO 11607-1 for surgical instruments sterilized by end user Other Medical Device Related Standards 1
M User manual / instructions for use for class II device always required? Medical Device and FDA Regulations and Standards News 3
D Do User Manuals (Not Device Labeling) HAVE to be in their national languages for these countries? Will English Hardcopy not do? EU Medical Device Regulations 12
A Cassette Representation - GUI (Graphical User Interface) on my medical device - A mammography Device Other Medical Device Related Standards 0
R Medical device software without user interface Other Medical Device and Orthopedic Related Topics 3
F EUDAMED UDI Medical Devices User's Guide Medical Device and FDA Regulations and Standards News 7
M Informational US FDA Medical Device User Fee Rates for Fiscal Year 2020 Medical Device and FDA Regulations and Standards News 0
K EU MDR Art. 22 - Device + insertion pack - User manual and Labeling EU Medical Device Regulations 4
G Posting Measuring Equipment Accuracy for User Information General Measurement Device and Calibration Topics 4
M Does ISO 13485 or MDR require you to state the origins of customer requirements or user needs? Design and Development of Products and Processes 2
V Sequence of performing risk assessment: User_FMEA (User Errors) vs Design Inputs FMEA and Control Plans 1
Ed Panek Splitting UI (User Interface) into two development paths 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
R Publication of user information in manufacturer website for medical devices Other Medical Device Regulations World-Wide 2
Ed Panek User Feedback both negative and positive and acting upon those metrics 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
P Detection rating for a user (surgeon) related failure mode in DFMEA APQP and PPAP 3
Marc Search - Search for Discussion Threads started by a specific User Elsmar Xenforo Forum Software Instructions and Help 0
Marc Search for Posts - By specific User Name(s) Elsmar Xenforo Forum Software Instructions and Help 1
M Digital user manuals CE Marking (Conformité Européene) / CB Scheme 0
Marc User Agents of Forum Visitors - 6 November 2018 Forum News and General Information 0
Marc User Post Counts - 20181101 Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 0
Marc Forum User Name - I Want to Change my Forum User Name Elsmar Xenforo Forum Software Instructions and Help 0
Marc 9 September 2018 - Upcoming User Group Changes Forum News and General Information 1
shrutisancheti EU User manual / operator manual / service manual guidance document(s) CE Marking (Conformité Européene) / CB Scheme 2
D How to deal with user needs when it is obvious the design meets the user need 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
shrutisancheti Upgrading medical device at healthcare establishments (user facility) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
D Definition User Needs - Concrete definition for "User Needs" as required by the FDA Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 2
M User Errors and Product Nonconformances Nonconformance and Corrective Action 22
G Design and development of user centric audit report visualisation tool Design and Development of Products and Processes 5
T New to WEEE Directive - Selling a medical device directly to a professional end-user RoHS, REACH, ELV, IMDS and Restricted Substances 1
Ajit Basrur Looking for examples of "User Training" - ISO 13485 section 7.2.1 d) ISO 13485:2016 - Medical Device Quality Management Systems 6
M User Interface of Unknown Provenance (UOUP) applicability IEC 62366 - Medical Device Usability Engineering 8
J TOPCON PP-70 Optical Comparator - User Manual Needed General Measurement Device and Calibration Topics 0
P Datron/Wavetek 4808 Option 70 Wideband Source - User and Service Manuals needed General Measurement Device and Calibration Topics 2
J Who is the Customer - Who is the End User Manufacturing and Related Processes 2
S Trying to understand 7.2.1(d) of ISO 13485 - Medical Device User Training ISO 13485:2016 - Medical Device Quality Management Systems 8
JoCam User Manual Release before CE Mark EU Medical Device Regulations 5
D User Requirements Tracing - Verification and Validation Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
L When FDA receives an MDR from user and sends a letter to the manufacturer Other Medical Device and Orthopedic Related Topics 3
D Biological and Chemical Risks to the user in the Hazard Analysis ISO 14971 - Medical Device Risk Management 1

Similar threads

Top Bottom