prEN ISO/IEEE 11073-10700
(Main)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 (ISO/IEEE FDIS 11073-10700:2024)
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 (ISO/IEEE FDIS 11073-10700:2024)
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.
Medizinische Informatik - Interoperabilität von Geräten - Teil 10700: Kommunikation persönlicher Gesundheitsgeräte - Standard für Basisanforderungen für Teilnehmer an einem serviceorientierten Gerätekonnektivitätssystem (SDC) (ISO/IEEE FDIS 11073-10700:2024)
Informatique de santé - Interopérabilité des dispositifs - Partie 10700: Titre manque (ISO/IEEE FDIS 11073-10700:2024)
La présente norme spécifie l’ensemble de base des objectifs clés des participants pour la série de normes relatives à la connectivité des dispositifs orientés services (SDC). Les objectifs clés des participants sont des ensembles d’exigences basés sur les rôles pour les produits afin de favoriser une interopérabilité sûre, efficace et sécurisée dans les réseaux TI médicaux sur les sites des soins tels que l’unité de soins intensifs (USI), la salle d’opération (OR) ou d’autres environnements de soins aigus. La présente norme spécifie à la fois le processus de développement du produit et les exigences techniques.
Zdravstvena informatika - Interoperabilnost naprav - 10700. del: Komunikacija medicinskih naprav na mestu oskrbe - Standard za osnovne zahteve za udeležence v storitvi - Sistem usmerjenega povezovanja naprav (SDC) (ISO/IEEE FDIS 11073-10701:2024)
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-junij-2024
Zdravstvena informatika - Interoperabilnost naprav - 10700. del: Komunikacija
medicinskih naprav na mestu oskrbe - Standard za osnovne zahteve za
udeležence v storitvi - Sistem usmerjenega povezovanja naprav (SDC) (ISO/IEEE
FDIS 11073-10701:2024)
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 (ISO/IEEE FDIS 11073-10700:2024)
Medizinische Informatik - Interoperabilität von Geräten - Teil 10700: Kommunikation
persönlicher Gesundheitsgeräte - Standard für Basisanforderungen für Teilnehmer an
einem serviceorientierten Gerätekonnektivitätssystem (SDC) (ISO/IEEE FDIS 11073-
10700:2024)
Informatique de santé - Interopérabilité des dispositifs - Partie 10700: Titre manque
(ISO/IEEE FDIS 11073-10700:2024)
Ta slovenski standard je istoveten z: prEN ISO 11073-10700
ICS:
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
11073-10700
ISO/TC 215
Health informatics — Device
Secretariat: ANSI
interoperability —
Voting begins on:
2024-04-11
Part 10700:
Point‐of‐Care Medical Device
Voting terminates on:
2024-08-29
Communication –Standard for Base
Requirements for Participants
in a Service‐Oriented Device
Connectivity (SDC) System
This document is circulated as received from the committee 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 1107310700:2024(en) © IEEE 2024
FINAL DRAFT
ISO/IEEE FDIS 11073-10700:2024(en)
International
Standard
ISO/IEEE
FDIS
11073-10700
ISO/TC 215
Health informatics — Device
Secretariat: ANSI
interoperability —
Voting begins on:
Part 10700:
Point‐of‐Care Medical Device
Voting terminates on:
Communication –Standard for Base
Requirements for Participants
in a Service‐Oriented Device
Connectivity (SDC) System
This document is circulated as received from the committee 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
© IEEE 2024
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO
ISO/CEN PARALLEL PROCESSING
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
the internet or an intranet, without prior written permission. Permission can be requested from IEEE at the address below.
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Published in Switzerland Reference number
ISO/IEEE FDIS 1107310700:2024(en) © IEEE 2024
© IEEE 2024 – All rights reserved
ii
ISO/IEEE 11073-10700:2024(en)
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ISO/IEEE 11073-10700:2024(en)
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.
Any feedback or questions on this document should be directed to the user’s national standards body. A complete
listing of these bodies can be found at www.iso.org/members.html.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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ISO/IEEE 11073-10700:2024(en)
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