Interpretation Response #08-0075 ([Terumo Heart, Inc.                                                          ] [Mr. Keith Proctor                                                                            ])

Below is the interpretation response detail and a list of regulations sections applicable to this response.

Interpretation Response Details

Response Publish Date: 07/22/2008

Company Name: Terumo Heart, Inc.                                                          

Individual Name: Mr. Keith Proctor                                                                            

Location State: MI Country: US

View the Interpretation Document

Response text:

July 22, 2008

Mr. Keith Proctor

Terumo Heart, Inc.

6180 Jackson Road

Ann Arbor, MI 48103

Ref. No.: 08-0075

Dear Mr. Proctor:

This is in response to your February 26, 2008 letter concerning requirements under the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) for design-type testing of lithium-ion batteries.  As described in your letter, your company manufactures a medical device powered by a lithium-ion battery pack.  The previous design (the S2) has been tested (both the individual cells and the battery pack) in accordance with the UN Manual of Tests and Criteria (tests T1 " T8 contained in section 38.3).  Your company is planning on replacing the S2 battery with a new battery (the S3).  The S3 cells have successfully passed the UN T1 " T8 tests; however, the battery pack made with S3 cells has not been tested.   You ask if you must perform the UN T1 " T8 tests on the battery pack made with the S3 cells.

In your letter you state that the new battery pack will have an increase of equivalent lithium content of 0.144 gram.  In accordance with section 38.2 of the UN Manual of Test and Criteria, a change of more than 0.1 gram or 20 percent by mass, whichever is greater, to the cathode, to the anode, or to the electrolyte is considered a new battery.  Therefore, the new battery pack described in your letter is subject to the UN T1 " T8 tests.  You should also be aware that your batteries as described in your letter are considered "small lithium batteries" under the HMR, and as such are not subject to the UN T1 " T8 testing for domestic transportation until October 1, 2009 (see enclosed Docket HM 224C and HM 224E, published August 9, 2007 (72 FR 44929)).

I hope this information is helpful. If you have further questions, please do not hesitate to contact this office.

Sincerely,

Hattie L. Mitchell

Chief, Regulatory Review and Reinvention

Office of Hazardous Materials Standards

Enclosure

Regulation Sections