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ISO/ IEEE 11073-10700 was prepared by the IEEE 11073 Standards Committee of the IEEE Engineering in Medicine and Biology Society (as IEEE Std 11073-10700 ) and drafted in accordance with its editorial rules. It was adopted, under the “fast-track procedure” defined in the Partner Standards Development Organization cooperation agreement between ISO and IEEE, by Technical Committee ISO/TC 215, Health informatics.

A list of all parts in the ISO 11073 series can be found on the ISO website.

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Abstract: Medical devices that offer a communication interface as specified by the IEEE 11073 Service-oriented Device Connectivity (SDC) standards can be integrated into a health IT system to jointly execute system functions. However, implementing the IEEE 11073 SDC communication protocol is not sufficient to demonstrate safety, effectiveness, and security of system functions resulting from the combination of system function contributions from two or more medical devices. SDC participant key purposes (PKPs) are sets of requirements that allow for manufacturers to have certain expectations about BICEPS participants from other manufacturers. This common understanding enables the manufacturers to perform risk management, verification, validation, and usability engineering for the safe use of system functions. This standard specifies requirements for the allocation of responsibilities to SDC base participants.

Keywords: base PKP; BICEPS; communication protocol specification; documentation and process responsibilities; dynamic medical device interoperability; IEEE 11073-10700 ™; integrated clinical environment; participant key purpose; point-of-care medical device communication; risk management; SDC; service-oriented device connectivity; safety, effectiveness, and security; system function; system function contribution; usability engineering

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Participants

At the time this IEEE standard was completed, the Point-of-Care Devices Working Group had the following membership:

Stefan Schlichting, Chair

Martin Kasparick, Subgroup Chair

Björn Andersen

Fabian Baumeister

Jin-Woo Choi

Malcolm Clarke

Paul Close

Todd Cooper

Sandra Costanzo

Steven Dain

Kurt Elliason

Javier Espina

Michael Faughn

Ken Fuchs

John Garguilo

Frank Golatowski

David Gregoczyk

Steve Griffiths

Peter Gunter

Bob Harbort

Christian Haye

Werner Hoelzl

Martin Hurrell

Andy Iverson

Jennifer Jacobs

Sven Kämmer

Anton Keller

Tobias Klotz

Satoshi Kobayashi

Anil Kochhar

Peter Kranich

Ray Krasinski

Jithin Krishnan

Sungkee Lee

Konstantinos Makrodimitris

Koichiro Matsumoto

Jörg-Uwe Meyer

Madhu Mohan

Erik Moll

Karen Moniz

Jody Paul

Craig Reister

John Rhoads

Sean Rocke

Martin Rosner

Enrico Rudorf

Gilani Sadeghi

Paul Schluter

Elliot Silver

Tulasi Sivanesan

Isabel Tejero

James Vollmer

Brian Witkowski

Ravi Sekhar Yarrabothu

Greg Zeller

Daidi Zhong

The following members of the individual Standards Association balloting group voted on this standard. Balloters may have voted for approval, disapproval, or abstention.

Bjoern Andersen

Pradeep Balachandran

Fabian Baumeister

Lyle Bullock

Pin Chang

Diego Chiozzi

Todd Cooper

Houde Dai

Kurt Elliason

Michael Faughn

Immanuel Freedman

Kenneth Fuchs

David Fuschi

Frank Golatowski

David Gregorczyk

Werner Hoelzl

Piotr Karocki

Martin Kasparick

Stuart Kerry

Edmund Kienast

Yongbum Kim

Raymond Krasinski

Ting Li

Javier Luiso

H. Moll

Bansi Patel

Dalibor Pokrajac

John Rhoads

Elie Sarraf

Stefan Schlichting

Walter Struppler

Maria Isabel Tejero del Rio

John Vergis

Yu Yuan

Oren Yuen

When the IEEE SA Standards Board approved this standard on 8 November 2022, it had the following membership:

David J. Law, Chair

Ted Burse, Vice Chair

Gary Hoffman, Past Chair

Konstantinos Karachalios, Secretary

Edward A. Addy

Ramy Ahmed Fathy

J. Travis Griffith

Guido R. Hiertz

Yousef Kimiagar

Joseph L. Koepfinger ^*

Thomas Koshy

John D. Kulick

Johnny Daozhuang Lin

Kevin Lu

Daleep C. Mohla

Andrew Myles

Damir Novosel

Annette D. Reilly

Robby Robson

Jon Walter Rosdahl

Mark Siira

Dorothy V. Stanley

Lei Wang

F. Keith Waters

Karl Weber

Sha Wei

Philip B. Winston

Daidi Zhong

Introduction

This introduction is not part of IEEE Std 11073-10700-2022 , Health Informatics—Device Interoperability—Part 10700: Point-of-Care Medical Device Communication—Standard for Base Requirements for Participants in a Service-Oriented Device Connectivity (SDC) System.

The IEEE 11073 Point-of-Care Medical Device Communication Standards enable communication between health IT elements in a HEALTH IT SYSTEM including MEDICAL DEVICEs. They provide automatic and detailed electronic data capture of patient vital signs information and device operational data. The primary goals are to:

Provide real-time plug-and-play interoperability for MEDICAL DEVICEs. “Real-time” means that data from multiple MEDICAL DEVICEs can be retrieved, temporally correlated, displayed, and processed in fractions of a second. “Plug-and-play” means that there are no recurring configuration steps necessary to enable data exchange between MEDICAL DEVICEs.
Facilitate the efficient and effective exchange of vital signs and MEDICAL DEVICE data acquired at the PoC in all health care environments. “Efficient and effective exchange of MEDICAL DEVICE data” means that data captured at the PoC, e.g., patient vital signs, can be received, parsed, and interpreted by different types of applications without the loss of safety-critical information.

The IEEE 11073 Point-of-Care Medical Device Communication Standards are targeted at surgical as well as acute and continuous care devices, such as patient monitors, ventilators, infusion pumps, ECG devices, endoscopic camera systems, insufflators, dissectors, etc. They build a family of standards that can be bound to one another to provide optimized connectivity for devices at the PoC.

Within the context of the ISO/IEEE 11073 family of standards for Point-of-Care Medical Device Communication, this standard defines the requirements for SDC BASE PARTICIPANTs in an SDC SYSTEM that comprises an IT NETWORK of MEDICAL DEVICEs to enable safe and secure contribution to SYSTEM FUNCTIONs.

Acknowledgments

The author thanks the International Electrotechnical Commission (IEC) for permission to reproduce Information from its International Standards. All such extracts are copyright of IEC, Geneva, Switzerland. All rights reserved. Further information on the IEC is available from www.iec.ch. IEC has no responsibility for the placement and context in which the extracts and contents are reproduced by the author, nor is IEC in any way responsible for the other content or accuracy therein.

IEC 60601-1 ed.3.2	Copyright © 2020 IEC Geneva, Switzerland. www.iec.ch
IEC 60601-1-8 ed.2.0	Copyright © 2020 IEC Geneva, Switzerland. www.iec.ch
IEC 62366-1 ed.1.0	Copyright © 2020 IEC Geneva, Switzerland. www.iec.ch

The following material is reproduced from the International Organization for Standardization (ISO) with permission of the American National Standards Institute (ANSI) on behalf of ISO All rights reserved.

ISO 20417:2021, Sections 3.2 and 3.11

ISO 81001-1:2021, Sections 3.2, 3.14, 3.1.12, 3.3.8, and 3.3.11

ISO 14971:2019, Section 3.18

1 Overview

1.1 Scope

This standard specifies the base set of Participant Key Purposes (PKPs) for the Service-oriented Device Connectivity (SDC) series of standards. PKPs are role-based sets of requirements for products in order to support safe, effective, and secure interoperability in medical IT networks at point-of-care environments such as the intensive care unit (ICU), operating room (OR) or other acute care settings. This standard specifies both product development process and technical requirements.

1.2 Word usage

1.3 Service-oriented Device Connectivity standards

1.4 Participant key purposes

2 Normative references

3 Definitions, acronyms, and abbreviations

3.1 Definitions

3.2 Acronyms and abbreviations

4 Notational conventions

4.1 Requirement categories and numbering

4.2 References to IEEE 11073-10207 model elements

4.3 XML Schema namespaces

4.4 Notation of IEEE 11073 Nomenclature codes

5 Responsibilities

5.1 General responsibilities

5.2 Intended interoperability

5.3 System integration

5.4 System use

6 Technical design

6.1 SDC PARTICIPANT KEY PURPOSE conformity assurance

6.2 Standards conformity indication in the CONTAINMENT TREE

6.3 Cybersecurity

6.4 Logging

6.5 Maximum load conditions

6.6 Participant model

6.7 Extension model

6.8 Localization

6.9 Calibration

7 Conformity

7.1 Implementation conformity statements

ISO/IEEE 11073-10700:2024

Health informatics. Device interoperability - Point‐of‐care medical device communication. Standard for base requirements for participants in a Service‐oriented Device Connectivity (SDC) system

Current

Published:

16 Sep 2024