Can somebody tell me about Lithium Ion Battery pack related standards

I've begun researching all the standards that apply to Li ion.
Seems like there is alot. If I go with UL for testing, there is UL 1642 and UL 2054. That goes towards the UL NRTL mark. Then there is UN T testing, which goes towards shipping.
Those I can easily identify, but I am also discovering alot of IEEC(SP?) standards that mention Li ion batteries. How do I go about figuring which one of those I also need to comply to? I've looked at some of them and first thing I notice is ALOT of overlap. Vibration testing, heat cycle testing etc...
Other standards I find small tidbits that apply while the rest of the standard does not.
The battery in question would be a rechargeable secondary Li ion for a medical device.

Bruce Banner said:

I've begun researching all the standards that apply to Li ion.
Seems like there is alot. If I go with UL for testing, there is UL 1642 and UL 2054. That goes towards the UL NRTL mark. Then there is UN T testing, which goes towards shipping.
Those I can easily identify, but I am also discovering alot of IEEC(SP?) standards that mention Li ion batteries. How do I go about figuring which one of those I also need to comply to? I've looked at some of them and first thing I notice is ALOT of overlap. Vibration testing, heat cycle testing etc...
Other standards I find small tidbits that apply while the rest of the standard does not.
The battery in question would be a rechargeable secondary Li ion for a medical device.

Click to expand...

Can someone help Bruce?

Thank you!!

Stijloor.

To make any comments/judgements You have to be complete in your description!
What is it? (what is it attached to, obviously it is a battery)
What is it to the FDA?
Where will it be made?
Where will it be sold?
You have to define the item very accurately to get any accurate response.
UL performs testing, and has specific testing programs, and allows for custom ones.
The other guys are regional or world accepted standards. IEC&IEEE do well worldwide.
The FDA has rules to comply with., but some are exempt.
You should be reading the FDA FREE ACCESS 21CFR820 and or similar doc(s)
Medical devices are parts 800-1299
(CFR - Code of Federal Regulations Title 21) @
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ucm134499.htm
FDA medical Device Classification @
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/default.htm
Is your device FDA exempt?
Reviewing which standards provider covers your region of interest. IEC & IEEE do cover most.
Decide if UL is required.
There are a great deal of related standards and regulations, which selectively cover everything.

The battery would be a Li-on battery would be installed into a device and sold in the US and EU.
As far as I have looked, FDA doesn't have anything specific to LI-ON batteries.
The device is not FDA exempt.

I know it is not impossible, but so many Lithium Ion patteries are in packs for specific designed items.
Your battery is going to be a standard model/size,
and have UL and other testing to be done to be medical dedvice rated right?
If this is the case, then there would be the next question of what class of medical device?
There would be a different expectation from an implantable pace-maker battery,
and a night-light accessory to some hospital facility device.
There might be a test(s) requirements for the specific grade of battery operated medical device, the battery goes into.
The tests may not be lithium specific, but a battery-pack or battery still.
The FDA has a website that goes on for days in any kind of information hunt.
Just some Lithium Ion Battery Standards stuff:
Meeting MIL STD 810 for government applications is required @
http://www.micro-power.com/userfiles/file/mp_810packs-1260900318.pdf
MIL STD 810 @
http://www.wbdg.org/ccb/FEDMIL/std810f.pdf
The lower part of page 15 to 22 suggest STDs
UL-1642 testing @
http://www.ul.com/global/documents/offerings/industries/hightech/batteries/batterybrolow.pdf
battery discussion presentation @
http://www.batterypoweronline.com/images/Presentations/PRBA.pdf
IEEE-1725:2006: cell phones, portable devices
IEEE-11073:
IEEE-C95.6-2002: safety, emc
IEC-16610: safety
IEC-61960: safety, portable batteries
IEC-60050: measurement devices
IEC-60051: measurement devices
IEC-60086-1: primary batteries
IEC-60950: mobile cell safety
IEC-62133: tests for secondary cells, portable applications
IEC-61951: tests for secondary cells
IEC-61982-5: transportation testing (ENV testing to include vibration)
IEC-60068-2-64: transportation testing (ENV testing to include vibration)
IEC-62281: battery safety during transport
IEC/EN 61000-4-2: EMC immunity testing
IEC 68-2-27: shock testing
ANSI C18.3M: safety standard
ANSI/AAMI EC57: safety standard
In Europe:
WEEE directive, (for Europe): @
http://www.environ.ie/en/Legislation/Environment/Waste/WEEE/FileDownLoad,613,en-1.pdf
http://www.4pcb.com/media/Final%20WEEE%20Directive.pdf
RoHS directive, (for Europe): @
http://www.practicalcomponents.com/pdf/consultationpartiii.pdf
EBPA marking standard (for Europe): @
http://www.epbaeurope.net/BatteryMarkingGuidelines/battery_marking_guidelines.pdf