Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

062

Date of Entry 05/29/2024

FR Recognition Number

13-134

Standard

ISO IEEE 11073-10404 Second edition 2022-12
Health informatics - Personal health device communication - Part 10404: Device specialization - Pulse oximeter

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 11073-20601-2019 and describes a specific, interoperable communication approach for the pulse oximeter. 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 document establishes a normative definition of communication between personal telehealth pulse oximetry devices and compute engines (e.g., cell phones, personal computers, personal health appliances, 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 document defines a common core of communication functionality for personal telehealth pulse oximeters.

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FDA recognition of ISO IEEE 11073-10404 First edition 2010-05-01 [Rec# 13-54] will be superseded by recognition of ISO IEEE 11073-10404 Second edition 2022-12 [Rec# 13-134]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 13-54] until July 05, 2026. After this transition period, declarations of conformity to [Rec# 13-54] will not be accepted.

Public Law, CFR Citation(s) and Procode(s)*

Regulation Number	Device Name	Device Class	Product Code
§870.2700	Oximeter	Class 2	DQA
§870.2700	Oximeter, Reprocessed	Class 2	NLF
§870.2710	Oximeter, Ear	Class 2	DPZ

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.
10. Pulse Oximeters - Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration Staff, issued March 2013.
11. ISO 80601-2-61 First edition 2011-04-01, Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment.
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

Sandy Weininger

FDA/OC/CDRH/OSEL/DBP/

301-796-2582

sandy.weininger@fda.hhs.gov

Neel Patel

FDA/OC/CDRH/OPEQ/OHTI/DHTIC/

301-796-6274

Neel.Patel@fda.hhs.gov

Standards Development Organizations