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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 036 Date of Recognition 07/09/2014 
FR Recognition Number 13-68
Standard
ISO 11073-90101 First edition 2008-01-15
Health informatics - Point-of-care medical device communication - Part 90101: Analytical instruments -- Point-of-care test
Scope/Abstract
ISO 11073-90101:2008 establishes a set of specifications to allow seamless multivendor interoperability and communication between point-of-care devices, data concentrators, and clinical information systems. CLSI document POCT1 provides the framework for engineers to design devices, workstations and interfaces that allow multiple types and brands of point-of-care devices to communicate bidirectionally with access points, data concentrators and laboratory information systems from a variety of vendors.

As an interface standard, ISO 11073-90101:2008 specifies the common communication interfaces and protocols between systems and devices. It facilitates the transfer of data to support the creation of point-of-care applications, services and institutional policies. This International Standard does not directly address specific point-of-care application and service level functions, such as device lockout and operator list management. It specifies protocol, not policy. The interfaces specified support the communication required for engineers to build such application-level functionality. Specifying, building and providing the applications to support these services are left to customers, device and information system vendors.

Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§862.2100 Calculator/Data Processing Module, For Clinical Use Class 1 JQP
Relevant FDA Guidance and/or Supportive Publications
General Principles of Software Validation; Final Guidance for Industry and FDA Staff, Document issued on January 11, 2002
FDA Technical Contact
 Kristian Roth
  FDA/OMPT/CDRH/OIR/DMD/BAC2/
  301-796-7024
  kristian.roth@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Software/Informatics
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