• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 062 Date of Entry 05/29/2024 
FR Recognition Number 13-133
Standard
ISO IEEE  11073-10415 Second edition 2022-12
Health informatics - Point-of-care medical device communication - Part 10415: Device specialization - Weighing scale
Scope/Abstract
ISO/IEEE 11073 standards enable communication between medical devices and external computer systems. This document uses the optimized framework created in IEEE Std 11073-20601 and describes a specific, interoperable communication approach for weighing scales. These standards align with and draw on the existing clinically focused standards to provide support for communication of data from clinical or personal health devices. Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard establishes a normative definition of communication between personal telehealth weighing scale devices and compute engines (e.g., cell phones, personal computers, personal health appliances, and set top boxes) in a manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards including ISO/IEEE 11073 terminology, information models, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments restricting optionality in base frameworks in favor of interoperability. This standard defines a common core of communication functionality for personal telehealth weighing scales. ISO/IEEE 11073 standards enable communication between medical devices and external computer 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.
Transition Period
FDA recognition of ISO IEEE 11073-10415 First edition 2010-05-01 [Rec# 13-53] will be superseded by recognition of ISO IEEE 11073-10415 Second edition 2022-12 [Rec# 13-133]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 13-53] until July 05, 2026. After this transition period, declarations of conformity to [Rec# 13-53] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§880.2700 Scale, Stand-On, Patient Class 1 FRI
Relevant FDA Guidance and/or Supportive Publications*

1. Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2017.
2. Content of Premarket Submissions for Device Software Functions - Guidance for Industry and Food and Drug Administration Staff, issued June 2023.
3. Off-The-Shelf Software Use in Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued August 2023.
4. Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2022.
5. Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions - Guidance for Industry and Food and Drug Administration Staff, issued September 2023.
6. Guidance for Industry - Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software, issued January 2005.
7. Postmarket Management of Cybersecurity in Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued December 2016.
8. Policy for Device Software Functions and Mobile Medical Applications - Guidance for Industry and Food and Drug Administration Staff, issued September 2022.
9. General Principles of Software Validation - Guidance for Industry and FDA Staff, issued January 2002.
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
 Weihong Gu
  FDA/OC/CDRH/OPEQ/OHTIII/DHTIIIC/
  301-796-6973
  weihong.gu@fda.hhs.gov
 Maria Isabel Tejero Del Rio
  FDA/OC/CDRH/OPEQ/OHTIII/
  301-796-5322
  Isabel.Tejero@fda.hhs.gov
Standards Development Organizations
ISO International Organization for Standardization https://www.iso.org/
IEEE Institute of Electrical and Electronic Engineers https://www.ieee.org/
FDA Specialty Task Group (STG)
Software/Informatics
*These are provided as examples and others may be applicable.
-
-