prEN ISO/IEEE 11073-10419

• Abstract:

  This standard establishes a normative definition of communication between personal telehealth insulin pump devices (agents) and managers (e.g., cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play interoperability. It leverages work done in other ISO/IEEE 11073 standards including existing terminology, information profiles, 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 functionality of personal telehealth insulin pump devices. ; In the context of personal health devices (PHDs), an insulin pump is a medical device used for the administration of insulin in the treatment of diabetes mellitus, also known as continuous subcutaneous insulin infusion (CSII) therapy. ; This standard provides the data modeling according to ISO/IEEE 11073-20601 and does not specify the measurement method.

• Status: Not Published
• Publication Date: 02-Apr-2028
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: CEN/TC 251 - Medical informatics
• Current Stage: 4020 - Submission to enquiry - Enquiry
• Start Date: 16-Jul-2026
• Completion Date: 16-Jul-2026
• Ref Project: oSIST prEN ISO/IEEE 11073-10419:2026 - Health informatics - Personal health device communication - Part 10419: Device specialization - Insulin pump (ISO/IEEE FDIS 11073-10419:2026)

• Consolidated By: ISO/IEEE FDIS 11073-10419 - Health informatics — Device interoperability — Part 10419: Personal health device communication, device specialization, insulin pump
• Effective Date: 30-May-2026
• Revises: EN ISO/IEEE 11073-10419:2023 - Health informatics - Personal health device communication - Part 10419: Device specialization - Insulin pump (ISO/IEEE 11073-10419:2019)
• Effective Date: 20-May-2026

Overview

prEN ISO/IEEE 11073-10419:2026 defines the requirements for communication between personal health insulin pump devices and managing systems, such as smartphones, personal computers, and specialized health appliances. Developed by CEN in collaboration with ISO and IEEE, this standard builds on the ISO/IEEE 11073 family of standards for personal health device (PHD) communication, focusing on plug-and-play interoperability. By specifying consistent terminology, data formats, and protocols, it enables seamless and reliable data exchange in telehealth environments.

Insulin pumps, as addressed in this standard, are medical devices used for the continuous subcutaneous delivery of insulin for diabetes management. This standard is critical in supporting effective integration and use of insulin pumps within personal health informatics solutions, enhancing patient outcomes and interoperability between devices and platforms.

Key Topics

• Interoperable Communication: The standard provides a normative framework for plug-and-play interoperability between insulin pump devices (agents) and managers (computing systems), reducing fragmentation in the telehealth ecosystem.
• Standardized Information Models: Leverages modeling constructs from ISO/IEEE 11073-20601, ensuring compatible and structured data exchange between devices and managers.
• Core Device Functionality: Defines common core functionalities and behaviors expected from personal telehealth insulin pump devices, promoting consistency in device capabilities within the telehealth environment.
• Use of Existing Standards: Utilizes standardized terminology, information profiles, application profiles, and transport standards from the ISO/IEEE 11073 suite, harmonizing with broader health device standards.
• Restricted Optionality: Limits the optional elements in base frameworks to prioritize interoperability, ensuring reliable communication and reducing the risk of integration issues.

Applications

prEN ISO/IEEE 11073-10419:2026 plays a central role in the medical device interoperability landscape, particularly for diabetes care management. Key applications include:

• Telehealth Integration: Enables effective real-time monitoring and management of insulin pump therapy within homecare and remote monitoring scenarios.
• Mobile and Cloud Health Platforms: Facilitates secure, standardized data transfer between insulin pumps and mobile applications or cloud systems, supporting trend analysis and remote clinician access.
• Personal Health Record Systems: Supports the aggregation of insulin delivery data into electronic health records (EHRs), enabling more comprehensive patient health management.
• Cross-Vendor Compatibility: Allows insulin pump devices from different manufacturers to communicate reliably with certified manager devices, enhancing patient choice and device adoption.
• Research and Development: Provides a stable, well-documented interface for developers, encouraging innovation in personal health informatics and advanced diabetes management solutions.

Related Standards

• ISO/IEEE 11073-20601: Framework for optimized communication between personal health devices and managing systems; the basis for data modeling in this standard.
• ISO/IEEE 11073-104xx Series: Device specialization standards for other personal health devices (e.g., blood pressure monitors, glucose meters).
• ISO/IEEE 11073-10101: Standardized nomenclature and terminologies for medical device communication.
• ISO/IEC 11756: Guidelines for telehealth and remote patient monitoring, often referenced alongside ISO/IEEE 11073 standards.
• HL7 and FHIR: Interoperability standards for the representation and exchange of health data, compatible with ISO/IEEE 11073 output.

Practical Value

Implementing prEN ISO/IEEE 11073-10419:2026 ensures that insulin pump data can be effectively integrated into modern telehealth and health informatics platforms. This contributes to better diabetes management, enables comprehensive health tracking, and supports regulatory compliance with international interoperability and safety standards. Health device manufacturers, application developers, and healthcare providers all benefit from the stability, security, and integration advantages provided by this harmonized standard.

SLOVENSKI STANDARD
01-september-2026
Zdravstvena informatika - Komunikacija osebnih zdravstvenih naprav - 1. del
10419: Specializacija naprav - Inzulinska črpalka (ISO/IEEE FDIS 11073-
10419:2026)
Health informatics - Personal health device communication - Part 10419: Device
specialization - Insulin pump (ISO/IEEE FDIS 11073-10419:2026)
Medizinische Informatik - Kommunikation von Geräten für die persönliche Gesundheit -
Teil 10419: Gerätespezifikation - Insulinpumpe (ISO/IEEE FDIS 11073-10419:2026)
Informatique de santé - Communication entre dispositifs de santé personnels - Partie
10419: Spécialisation des dispositifs - Pompe à insuline (ISO/IEEE FDIS 11073-
10419:2026)
Ta slovenski standard je istoveten z: prEN ISO/IEEE 11073-10419
ICS:
11.040.55 Diagnostična oprema Diagnostic equipment
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

FINAL DRAFT
International
Standard
ISO/IEEE
FDIS
11073-10419
ISO/TC 215
Health informatics — Device
Secretariat: ANSI
interoperability —
Voting begins on:
2026-07-14
Part 10419:
Personal health device
Voting terminates on:
2026-12-01
communication, device
specialization, insulin pump
This document has not been edited by the ISO Central Secretariat.
FAST TRACK PROCEDURE
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/CEN PARALLEL PROCESSING LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
ISO/IEEE FDIS 11073­10419:2026(en) © IEEE 2026

FINAL DRAFT
ISO/IEEE FDIS 11073-10419:2026(en)
International
Standard
ISO/IEEE
FDIS
11073-10419
ISO/TC 215
Health informatics — Device
Secretariat: ANSI
interoperability —
Voting begins on:
Part 10419:
Personal health device
Voting terminates on:
communication, device
specialization, insulin pump
This document has not been edited by the ISO Central Secretariat.
FAST TRACK PROCEDURE
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPORTING D OCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
© IEEE 2026
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/CEN PARALLEL PROCESSING
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
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Published in Switzerland Reference number
ISO/IEEE FDIS 11073­10419:2026(en)
© IEEE 2024
© IEEE 2026 – All rights reserved
ii
ISO/IEEE 11073-10419:2026(en)
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© IEEE 2024 – All rights reserved
iii
IEEE Std 11073-10419™-2023
(Revision of IEEE Std 11073-10419-2017)
Health informatics—Device interoperability
Part 10419: Personal Health Device
Communication—Device
Specialization—Insulin Pump
Developed by the
IEEE 11073™ Standards Committee
of the
IEEE Engineering in Medicine and Biology Society
6 December 2023
IEEE SA Standards Board
Recognized as an American National Standard
ISO/IEEE 11073-10419:2026(en)
Abstract: Within the context of the ISO/IEEE 11073 family of standards for device
communication, a normative definition of communication between personal telehealth insulin
pump 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, is
established in this standard. Appropriate portions of existing standards including ISO/IEEE
11073 terminology, information models, application profile standards, and transport standards
are leveraged. The use of specific term codes, formats, and behaviors in telehealth
environments restricting optionality in base frameworks in favor of interoperability are
specified. A common core of communication functionality for personal telehealth insulin pump
devices is defined.
Keywords: IEEE 11073-10419™, insulin pump, medical device communication, personal
health devices
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Participants
At the time this standard was completed, the Personal Health Devices Working Group had the
following membership:
Daidi Zhong, Chair
Malcolm Clarke, Vice-Chair
Raymond Krasinski, Secretary
Karsten Aalders Hans Crommenacker Nathaniel Heintzman
Charles R. Abbruscato Tomio Crosley Charles Henderson
Nabil Abujbara Allen Curtis Jun-Ho Her
Maher Abuzaid Jesús Daniel Trigo Timothy L. Hirou
James Agnew David Davenport Allen Hobbs
Manfred Aigner Russell Davis Alex Holland
Jorge Alberola Sushil K. Deka Arto Holopainen
David Aparisi Ciro de la Vega Kris Holtzclaw
Lawrence Arne Jim Dello Stritto Robert Hoy
Diego B. Arquillo Kent Dicks Anne Huang
Serafin Arroyo Hyoungho Do Guiling Huang
Muhammad Asim Fangjie Dong Haofei Huang
Kit August Jonathan Dougherty Zhiyong Huang
Doug Baird Xiaolian Duan David Hughes
David Baker Sourav Dutta Robert D. Hughes
Anindya Bakshi Jakob Ehrensvard Jiyoung Huh
Ananth Balasubramanian Fredrik Einberg Hugh Hunter
Sunlee Bang Javier Escayola Calvo Philip O. Isaacson
M. Jonathan Barkley Mark Estes Atsushi Ito
Gilberto Barrón Leonardo Estevez Michael Jaffe
David Bean Bosco T. Fernandes Praduman Jain
John Bell Christoph Fischer Danny Jochelson
Olivia Bellamou-Huet Morten Flintrup Akiyoshi Kabe
Rudy Belliardi Russell Foster Steve Kahle
Daniel Bernstein Eric Freudenthal Tomio Kamioka
George A. Bertos Matthias Frohner James J. Kang
Chris Biernacki Ken Fuchs Kei Kariya
Ola Björsne Jing Gao Andy Kaschl
Thomas Blackadar Marcus Garbe Junzo Kashihara
Thomas Bluethner John Garguilo Ralph Kent
Douglas P. Bogia Liang Ge Laurie M. Kermes
Xavier Boniface Rick Geimer Sanjay R. Kharche
Shannon Boucousis Igor Gejdos Ahmad Kheirandish
Lyle G. Bullock, Jr. Ferenc Gerbovics Junhyung Kim
Bernard Burg Alan Godfrey Minho Kim
Chris Burns Nicolae Goga Min-Joon Kim
Jeremy Byford-Rew Julian Goldman Taekon Kim
Satya Calloji Raul Gonzalez Gomez Tetsuya Kimura
Carole C. Carey Chris Gough Michael J. Kirwan
Craig Carlson Channa Gowda Alfred Kloos
Santiago Carot-Nemesio Charles M. Gropper Edward Koch
Seungchul Chae Amit Gupta Jeongmee Koh
Yao Chen Jeff Guttmacher Jean-Marc Koller
Jing Cheng Rasmus Haahr John Koon
Peggy Chien Christian Habermann Patty Krantz
David Chiu Michael Hagerty Alexander Kraus
Jinyong Choi Jerry Hahn Ramesh Krishna
Chia-Chin Chong Robert Hall Geoffrey Kruse
Jinhan Chung Shu Han Falko Kuester
John A. Cogan Nathaniel Hamming Rafael Lajara
John T. Collins Rickey L. Hampton Pierre Landau
Cory Condek Sten Hanke Jaechul Lee
Todd H. Cooper Aki Harma JongMuk Lee
Sandra Costanzo Jordan Hartmann Kyong Ho Lee
Douglas Coup Kai Hassing Rami Lee
Nigel Cox Avi Hauser Sungkee Lee

ISO/IEEE 11073-10419:2026(en)
Woojae Lee Tong Bi Pei Hermanni Suominen
Jing Li Soren Petersen Lee Surprenant
Qiong Li James Petisce Ravi Swami
Xiangchen Li Peter Piction Ray Sweidan
Xiaoyu Li Michael Pliskin Haruyuyki Tatsumi
Patrick Lichter Varshney Prabodh Isabel Tejero
Jisoon Lim Jeff Price Chn Jonas Tirén
Wei-Jung Lo Harald Prinzhorn Janet Traub
Charles Lowe Lifei Qian Gary Tschautscher
Ling Luo Harry Qiu Masato Tsuchid
Don Ludolph Tanzilur Rahman Ken Tubman
Christian Luszick Lin Ran Akib Uddin
Bob MacWilliams Phillip Raymond Sunil Unadkat
Srikkanth Terrie Reed Fabio Urbani
Madhurbootheswaran Barry Reinhold Philipp Urbauer
Miriam L. Makhlouf Brian Reinhold Laura Vanzago
M. Sabarimalai Manikandan John G. Rhoads Alpo Värri
Romain Marmot Jeffrey S. Robbins Andrei Vasilateanu
Sandra Martinez Chris Roberts Dalimar Velez
Miguel Martínez de Moskowitz Robert Martha Velezis
Espronceda Cámara Stefan Robert Rudi Voon
Peter Mayhew Scott M. Robertson Isobel Walker
Jim McCain Timothy Robertson David Wang
László Meleg Sean Rocke Jerry P. Wang
Alexander Mense David Rosales Shiwei Wang
Behnaz Minaei Bill Saltzstein Yao Wang
Jinsei Miyazaki Giovanna Sannino Yi Wang
Madhu Mohan Jose A. Santos-Cadenas Steve Warren
Erik Moll Stefan Sauermann Fujio Watanabe
Darr Moore John Sawyer Toru Watsuji
Chris Morel Alois Schloegl Kathleen Wible
Carsten Mueglitz Paul S. Schluter Paul Williamson
Soundharya Nagasubramanian Mark G. Schnell Jia-Rong Wu
Alex Neefus Richard A. Schrenker Will Wykeham
Trong-Nghia Nguyen- Antonio Scorpiniti Ariton Xhafa
Dobinsky Kwang Seok Seo Ricky Yang
Michael E. Nidd Riccardo Serafin Melanie S. Yeung
Jim Niswander Sid Shaw Qiang Yin
Hiroaki Niwamoto Frank Shen Done-Sik Yoo
Thomas Norgall Min Shih Zhi Yu
Yoshiteru Nozoe Mazen Shihabi Jianchao Zeng
Abraham Ofek Redmond Shouldice Jason Zhang
Brett Olive Sternly K. Simon Zerui Zhang
Begonya Otal Marjorie Skubic Hongbo Zhao
Marco Paleari Robert Smith Shibai Zhao
Bud Panjwani Ivan Soh Yu Zhao
Carl Pantiskas Motoki Sone Liang Zheng
Harry P. Pappas Emily Sopensky Yuanhong Zhong
Hanna Park Rajagopalan Srinivasan Qing Zhou
Jong-Tae Park Nicholas Steblay Miha Zoubek
Myungeun Park Lars Steubesand Szymon Zyskoter
Phillip E. Pash John (Ivo) Stivoric

ISO/IEEE 11073-10419:2026(en)
The following members of the individual Standards Association balloting group voted on this standard.
Balloters may have voted for approval, disapproval, or abstention.

Amelia Andersdotter Randall Groves H. Moll
Bjoern Andersen Werner Hoelzl Nick S. A. Nikjoo
Lyle G. Bullock, Jr. Noriyuki Ikeuchi Iulian Profir
Keith Chow Atsushi Ito Beth Pumo
Malcolm Clarke Piotr Karocki Walter Struppler
Joseph El Youssef Raymond Krasinski Ganesh Subramanian
David Fuschi Joerg-Uwe Meyer Oren Yuen

When the IEEE SA Standards Board approved this standard on 6 December 2023, it had the following
membership:
David J. Law, Chair
Ted Burse, Vice Chair
Gary Hoffman, Past Chair
Konstantinos Karachalios, Secretary
Sara R. Biyabani Joseph S. Levy Paul Nikolich
Doug Edwards Howard Li Annette D. Reilly
Ramy Ahmed Fathy Gui Lin Robby Robson
Guido R. Hiertz Johnny Daozhuang Lin Lei Wang
Yousef Kimiagar Xiaohui Liu F. Keith Waters
Joseph L. Koepfinger* Kevin W. Lu Karl Weber
Thomas Koshy Daleep C. Mohla Philip B. Winston
John D. Kulick Andrew Myles Don Wright
*Member Emeritus
ISO/IEEE 11073-10419:2026(en)
Introduction
This introduction is not part of IEEE 11073-10419-2023, Health informatics—Device interoperability—Part
10419: Personal Health Device Communication—Device Specialization—Insulin Pump.
ISO/IEEE 11073 standards enable communication between medical devices and external computer
systems. This document uses the optimized framework created in ISO/IEEE 11073-20601 and
describes a specific, interoperable communication approach for insulin pumps. 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.

For information on references, see Clause 2.

ISO/IEEE 11073-10419:2026(en)
Contents
1. Overview . 13
1.1 Scope . 13
1.2 Purpose . 13
1.3 Word usage . 14
1.4 Context . 14
2. Normative references . 14
3. Definitions, acronyms, and abbreviations. 15
3.1 Definitions . 15
3.2 Acronyms and abbreviations . 16
4. Introduction to ISO/IEEE 11073 personal health devices . 17
4.1 General . 17
4.2 Introduction to ISO/IEEE 11073-20601 modeling constructs . 18
4.3 Compliance with other standards . 18
5. Insulin pump device concepts and modalities . 19
5.1 General . 19
5.2 Device types . 20
5.3 Collected data . 20
5.4 Stored data . 26
5.5 Scheduled data . 26
6. Insulin pump domain information model . 26
6.1 Overview . 26
6.2 Object instance diagram . 27
6.3 Types of configuration . 28
6.4 Profiles . 29
6.5 Medical device system object . 29
6.6 Numeric objects . 32
6.7 Real-time sample array objects . 53
6.8 Enumeration objects . 53
6.9 PM-store objects . 59
6.10 Schedule-store objects . 64
6.11 Scanner objects . 72
6.12 Class extension objects . 73
6.13 Insulin pump information model extensibility rules . 73
7. Insulin pump service model . 73
7.1 General . 73
7.2 Object access services . 73
7.3 Object access event report services. 75
8. Insulin pump communication model . 75
8.1 Overview . 75
8.2 Communications characteristics . 76
8.3 Association procedure . 76
8.4 Configuring procedure . 78
8.5 Operating procedure . 80
8.6 Time synchronization . 80
9. Test associations . 80
9.1 Behavior with standard configuration . 81
9.2 Behavior with extended configurations . 81

ISO/IEEE 11073-10419:2026(en)
10. Conformance . 81
10.1 Applicability . 81
10.2 Conformance specification . 81
10.3 Levels of conformance . 82
10.4 Implementation conformance statements . 82
Annex A (informative) Bibliography . 91
Annex B (normative) Any additional ASN.1 definitions . 92
Annex C (normative) Allocation of identifiers . 93
C.1 General . 89
C.2 Definitions of terms and codes . 89
C.3 Systematic derivations of terms and codes . 91
Annex D (informative) Message sequence examples . 104
Annex E (informative) Protocol data unit examples . 106
E.1 General . 106
E.2 Association information exchange . 106
E.3 Configuration information exchange . 109
E.4 GET MDS attributes service . 114
E.5 Data reporting . 115
E.6 Disassociation . 116
Annex F (informative) Revision History . 117

ISO/IEEE 11073-10419:2026(en)
IEEE Std 11073-10419-2023
Health informatics—Device Interoperability—
Part 10419: Personal health device communication—Device Specialization—Insulin Pump
Health informatics—Device interoperability
Part 10419: Personal health device
communication—Device
Specialization—Insulin Pump
1. Overview
1.1 Scope
The scope of this standard is to establish a normative definition of communication between personal
telehealth insulin pump devices (agents) and managers (e.g., cell phones, personal computers, personal
health appliances, set top boxes) in a manner that enables plug-and-play interoperability. It leverages
work done in other ISO/IEEE 11073 standards including existing terminology, information profiles,
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 functionality of personal telehealth insulin pump
devices.
In the context of personal health devices, an insulin pump is a medical device used for the
administration of insulin in the treatment of diabetes mellitus, also known as continuous subcutaneous
insulin infusion (CSII) therapy.
This standard provides the data modeling according to the ISO/IEEE 11073-20601 standard, and does
not specify the measurement method.
1.2 Purpose
This standard addresses the need for an openly defined, independent standard that support information
exchange to and from personal health devices and compute engines (e.g., cell phones, personal
computers, personal health appliances, and set top boxes). Interoperability is key to growing the
potential market for these devices and enabling people to be better informed participants in the
management of their health.
IEEE Std 11073-10419-2023
Health informatics—Device Interoperability
Part 10419: Personal health device communication—Device Specialization—Insulin Pump
1.3 Word usage
The word shall indicates mandatory requirements strictly to be followed in order to conform to the
7,8
standard and from which no deviation is permitted (shall equals is required to).
The word should indicates that among several possibilities one is recommended as particularly suitable,
without mentioning or excluding others; or that a certain course of action is preferred but not
necessarily required (should equals is recommended that).
The word may is used to indicate a course of action permissible within the limits of the standard (may
equals is permitted to).
The word can is used for statements of possibility and capability, whether material, physical, or causal
(can equals is able to).
1.4 Context
See ISO/IEEE 11073-20601 for an overview of the environment within which this standard is written.
This standard defines the device specialization for the insulin pump [B1] being a specific agent type, and
provides a description of the device concepts, its capabilities, and its implementation according to this
standard.
This standard is based on ISO/IEEE 1
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