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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 052 Date of Entry 07/15/2019 
FR Recognition Number 19-35
UL  Standard for Standby Batteries
1989 Edition 5, 2013-10-02, ANSI November 2018
1.1 These requirements cover valve regulated or vented batteries that can be used as instrument batteries, enclosed batteries, emergency lighting and power batteries and uninterruptible power supply batteries. A battery system composed of vented or valve regulated types with battery management controls and other battery system components, and other chemistries or battery types are covered by the Standard for Batteries for Use in Stationary, Vehicle Auxiliary Power and Light Electric Rail (LER) Applications, UL 1973.

1.2 These requirements only address potential risks unique to the utilization of a battery supply in a product. Products employing a battery supply shall comply with the basic requirements contained in this standard applicable to the type of product and its intended use.

1.3 These requirements are intended to address aqueous electrolyte valve regulated or vented batteries such as lead acid, nickel-metal hydride, nickel zinc, or nickel cadmium, etc., and do not cover risks that may be unique to certain cell chemistries, such as the fire and explosion risks of lithium batteries. Lithium batteries are outside the scope of this standard.

1.4 The investigation of a family or group of batteries may be based on the investigation of batteries representative of the family or group.
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
 Iacovos Kyprianou
 Hamed Ghods
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.