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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 052 Date of Recognition 07/15/2019 
FR Recognition Number 13-109
Standard
AAMI ANSI UL 2800-1: 2019
(American National Standard) Standard for Safety for Medical Device Interoperability
Scope/Abstract
2.1 This Standard is applicable to INTEROPERABLE MEDICAL PRODUCTS, including assembled systems of INTEROPERABLE MEDICAL PRODUCTS that comprise or are intended to be incorporated into INTEROPERABLE MEDICAL SYSTEMS within an INTEROPERABLE ENVIRONMENT.

2.2 This Standard specifies a baseline set of requirements for assuring safe and secure interoperability for INTEROPERABLE MEDICAL SYSTEMS.

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
Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices - Guidance for Industry and Food and Drug Administration Staff, Issued September 2017.
FDA Technical Contact
 Sandy Weininger
  FDA/OMPT/CDRH/OSEL/DBP/
  301-796-2582
  sandy.weininger@fda.hhs.gov
Standards Development Organizations
AAMI Association for the Advancement of Medical Instrumentation http://www.aami.org
ANSI American National Standards Institute https://www.ansi.org/
UL Underwriters Laboratories, Inc. http://www.ul.com/
FDA Specialty Task Group (STG)
Software/Informatics
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