{"operation":"document","citation":"08-0075","title":"Terumo Heart, Inc. — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2008-07-22","effective_on":null,"summary":"08-0075 response to Terumo Heart, Inc. concerning 173.185.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-08-0075.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-08-0075.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-08-0075","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2008/080075.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department\nof Transportation\nPipeline and Hazardous\nMaterials Safety\nAdministration\n1200 New Jersey Avenue, SE\nWashington, D.C. 20590\nJUL 2 2 2008\nMr. Keith Proctor\nTerumo Heart Inc.\n6 180 Jackson Road\nAnn Arbor, MI 48 103\nRef. No.: 08-0075\nDear Mr. Proctor:\nThis is in response to your February 26, 2008 letter concerning requirements under the\nHazardous Materials Regulations (HMR; 49 CFR Parts 171 -1 80) for design-type testing of\nlithium-ion batteries. As described in your letter, your company manufactures a medical\ndevice powered by a lithium-ion battery pack. The previous design (the S2) has been tested\n(both the individual cells and the battery pack) in accordance with the UN Manual of Tests\nand Criteria (tests TI - T8 contained in section 38.3). Your company is planning on\nreplacing the S2 battery with a new battery (the S3). The S3 cells have successfully passed\nthe UN T1 - T8 tests; however, the battery pack made with S3 cells has not been tested.\nYou ask if you must perform the UN T1 - T8 tests on the battery pack made with the S3\ncells.\nIn your letter you state that the new battery pack will have an increase of equivalent lithium\ncontent of 0.144 gram. In accordance with section 38.2 of the UN Manual of Test and\nCriteria, a change of more than 0.1 gram or 20 percent by mass, whichever is greater, to the\ncathode, to the anode, or to the electrolyte is considered a new battery. Therefore, the new\nbattery pack described in your letter is subject to the UN T1 - T8 tests. You should also be\naware that your batteries as described in your letter are considered \"small lithium batteries\"\nunder the HMR, and as such are not subject to the UN TI - T8 testing for domestic\ntransportation until October 1,2009 (see enclosed Docket HM 224C and HM 224E,\npublished August 9,2007 (72 FR 44929)).\nI hope this information is helphl. If you have W h e r questions, please do not hesitate to\ncontact this office.\nHattie L. Mitchell\nChief, Regulatory Review and Reinvention\nOffice of Hazardous Materials Standards\nEnclosure\n\n<<<PAGE 2>>>\n\nPage 1 of 2\nDrakeford, Carolyn <PHMSA>\nFrom: Shelton, Paul <PHMSA>\nSent: Monday, March 17, 2008 3:39 PM\nTo: Drakeford, Carolyn <PHMSA>\nCc: Singh, Harpreet <PHMSA>\nSubject: FW: UN T I - T8 test requirements\nFrom: Proctor Keith\nSent: Tuesday, February 26, 2008 5:28 PM\nTo: 'approvals@dot.govl\nSubject: FW: LIN T1 - T8 test requirements\nTo Whom It May Concern,\nTerumo Heart, Inc. is a U.S. subsidiary of Terumo Corporation with headquarters and manufacturing\nfacilities in Ann Arbor, Michigan. The company's focus is the innovation and introduction of products\nto improve the quality of healthcare for heart failure patients. Specifically, Terumo Heart has developed\na Left Ventricular Assist Device to provide mechanical circulatory support for patients that have end\nstage left ventricular failure. A key component of this system is the rechargeable Lithium ion battery\npacks that are provided to power the implantable pump.\nThe current product uses a lithium ion cell produced by LG Chemical identified as S2, this cell is being\nreplaced by a similar cell from LG Chemical identified as S3. A copy of the MSDS sheets for both of\nthese battery cells is attached.\nThe current battery pack utilizes 8 S2 cells arranged in a 2P4S (two parallel four series) configuration.\nThe S3 replacement cells are direct replacements for the S2 cells. There are no changes required for the\nconfiguration, protection circuit, housing, or cabling.\nThe S2 and S3 cells have passed the UN tests T1 - T8 at the cell level. Terumo Heart has also\nconducted the UN tests T1 - T8 of the S2 battery pack. Our question is whether the UN tests T1 - T8 are\nrequired for the S3 battery packs.\nThe following table provides the Lithium content of the cell and pack for the two configurations.\nLithium content Lithium content\nThere is a 0.144 gram increase in the equivalent lithium content of the S3 battery pack as compared to\nthe S2 battery pack.\nPlease contact for any additional information requirements.\n\n<<<PAGE 3>>>\n\nPage 2 of 2\nSincerely,\nKeith Proctor\nDirector Regulatory Affairs and Quality Systems\nTerumo Heart Inc\n6 1 80 Jackson Road\nAnn Arbor MI 48 103\n734 741 -6360 direct\n978 394-0222 cell\nkeith.proctor@terumomedica1.com\nCONFIDENTIALITY NOTICE: This email contains information from the sender that may be\nconfidential, legally privileged, proprietary or otherwise protected from disclosure. This email is\nintended for use only by the person or entity to whom it is addressed. If you are not the intended\nrecipient, any use, disclosure, copying, distribution, printing, or any action taken in reliance on the\ncontents of this email, is strictly prohibited. If you received this email in error, please contact the\nsending party by replying in an email to the sender, delete the email from your computer system and\ndestroy any paper copies of the printed email.","truncated":false,"body_characters":4913}