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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 032 Date of Entry 08/06/2013 
FR Recognition Number 13-54
ISO IEEE  11073-10404 First edition 2010-05-01
Health informatics - Personal health device communication - Part 10404: Device specialization - Pulse oximeter
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 pulse oximeter 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 standard defines a common core of communication functionality for personal telehealth pulse oximeters.

Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
Definition of "Spot-Check" in Clause
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FDA recognition of ISO IEEE 11073-10404 First edition 2010-05-01 [Rec# 13-54] will be superseded by recognition of ISO IEEE 11073-10404 Second edition 2022-12 [Rec# 13-134].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*
Pulse Oximeters - Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration Staff

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
 Neel Patel
 Sandy Weininger
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)
*These are provided as examples and others may be applicable.