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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 036 Date of Entry 07/09/2014 
FR Recognition Number 19-11
UL  2054 2nd Edition
Household and Commercial Batteries
1.1 These requirements cover portable primary (nonrechargeable) and secondary (rechargeable) batteries for use as power sources in products. These batteries consist of either a single electrochemical cell or two or more cells connected in series, parallel, or both, that convert chemical energy into electrical energy by chemical reaction.

1.2 These requirements are intended to reduce the risk of fire or explosion when batteries are used in a product. The proper use of these batteries in a particular application is dependent on their use in a complete product that complies with the requirements applicable to such a product.

1.3 These requirements are intended to cover batteries for general use and do not include the combination of the battery and the host product which are covered by requirements in the host product standard.

1.4 These requirements are also intended to reduce the risk of injury to persons due to fire or explosion when batteries are removed from a product to be transported, stored, or discarded.

1.5 These requirements do not cover the toxicity risk that results from the ingestion of a battery or its contents, nor the risk of injury to persons that occurs if a battery is cut open to provide access to its contents.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contacts
 Charles Ho
 Hamed Ghods
 Iacovos Kyprianou
Standards Development Organization
UL Underwriters Laboratories, Inc. http://www.ul.com/
FDA Specialty Task Group (STG)
General II (ES/EMC)
*These are provided as examples and others may be applicable.