EN ISO 11073-30400:2012

Health informatics - Point-of-care medical device communication - Part 30400: Interface profile - Cabled Ethernet (ISO 11073-30400:2012)

The application of the Ethernet family (IEEE Std 802.3-2008) of protocols for use in medical device communication is addressed in ISO/IEEE 11073-30400:2012. The scope is limited to referencing the appropriate Ethernet family specifications and calling out any specific special needs or requirements of the ISO/IEEE 11073 environment, with a particular focus on easing interoperability and controlling costs.

Medizinische Informatik - Kommunikation von Geräten für die persönliche Gesundheit - Teil 30400: Interfaceprofil - drahtgebundenes Ethernet (ISO/IEEE 11073-30400:2012)

Informatique de santé - Communication entre dispositifs médicaux sur le site des soins - Partie 30400: Profil d'interface - Ethernet câblé (ISO 11073-30400:2012)

L'ISO/IEEE 11073-30400:2012 traite de l'application de la famille de protocoles Ethernet (IEEE 802.3-2008) destinés à être utilisés dans une communication de dispositifs médicaux. Le domaine d'application est limité au référencement des spécifications de la famille Ethernet appropriées et à l'énoncé de tous les besoins ou exigences particuliers spécifiques de l'environnement de l'ISO/IEEE 11073, et s'intéresse particulièrement à l'amélioration de l'interopérabilité et à la maîtrise des coûts

Zdravstvena informatika - Komunikacija medicinskih naprav na mestu oskrbe - 30400. del: Profil vmesnika - Ožičeni ethernet (ISO 11073-30400:2012)

Ta dokument se osredotoča na uporabo skupine ethernet protokolov (standard IEEE 802.3TM-2008) pri komunikaciji medicinskih naprav. Področje uporabe je omejeno na sklicevanje na ustrezne specifikacije skupine ethernet in pozivanje h kakršnim koli specifičnim posebnim potrebam ali zahtevam okolja standarda ISO/IEEE 11073, pri čemer se zlasti osredotoča na lajšanje interoperabilnosti in omejevanje stroškov.

General Information

• Status: Published
• Publication Date: 31-Oct-2012
• Withdrawal Date: 30-May-2013
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: CEN/TC 251 - Medical informatics
• Drafting Committee: CEN/TC 251/WG 2 - Terminology and knowledge representation
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 01-Nov-2012
• Completion Date: 01-Nov-2012
• Ref Project: SIST EN ISO 11073-30400:2013 - Health informatics - Point-of-care medical device communication - Part 30400: Interface profile - Cabled Ethernet (ISO 11073-30400:2012)

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Informatique de santé - Communication entre dispositifs médicaux sur le site des soins - Partie 30400: Profil d'interface - Ethernet câblé (ISO 11073-30400:2012)Health informatics - Point-of-care medical device communication - Part 30400: Interface profile - Cabled Ethernet (ISO 11073-30400:2012)35.240.80Uporabniške rešitve IT v zdravstveni tehnikiIT applications in health care technologyICS:Ta slovenski standard je istoveten z:EN ISO 11073-30400:2012SIST EN ISO 11073-30400:2013en,fr,de01-januar-2013SIST EN ISO 11073-30400:2013SLOVENSKI
STANDARD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN ISO 11073-30400
November 2012 ICS 35.240.80 English Version
Health informatics - Point-of-care medical device communication - Part 30400: Interface profile - Cabled Ethernet (ISO 11073-30400:2012)
Informatique de santé - Communication entre dispositifs médicaux sur le site des soins - Partie 30400: Profil d'interface - Ethernet câblé (ISO 11073-30400:2012)
This European Standard was approved by CEN on 20 October 2012.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2012 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11073-30400:2012: ESIST EN ISO 11073-30400:2013

Reference numberISO/IEEE 11073-30400:2012(E)© ISO 2012© IEEE 2012
INTERNATIONAL STANDARD ISO/IEEE11073-30400First edition2012-11-01Health informatics — Point-of-care medical device communication — Part 30400: Interface profile — Cabled Ethernet Informatique de santé — Communication entre dispositifs médicaux sur le site des soins — Partie 30400: Profil d'interface — Ethernet câblé
ISO/IEEE 11073-30400:2012(E)
ISO 2012 ©
IEEE 2012 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO or IEEE at the respective address below. ISO copyright office Institute of Electrical and Electronics Engineers, Inc. Case postale 56  CH-1211 Geneva 20 3 Park Avenue, New York  NY 10016-5997, USA Tel.
+ 41 22 749 01 11 E-mail
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+ 41 22 749 09 47 Web
www.ieee.org E-mail
[e-mail] Web
www.iso.org Published in Switzerland
ii © ISO 2012 – All rights reserved© IEEE 2012 – All rights reserved
ISO/IEEE 11073-30400:2012(E) © ISO 2012 – All rights reserved © IEEE 2012 – All rights reserved iii
Contents 1. Overview.1 1.1 Scope.1 1.2 Purpose.1 2. Normative references.2 3. Definitions, acronyms, and abbreviations.2 3.1 Definitions.2 3.2 Acronyms and abbreviations.4 4. Clinical connectivity context.5 4.1 Clinical Point-of-Care deployment diagram.5 4.2 Use of normative references.6 4.3 High-level intent.6 4.4 Mapping “PoC reference points” to “high-level intent”.7 4.5 Compliance with other standards.8 5. Marking and cabling.8 5.1 Port marking.8 5.2 Cable and connector marking.9 5.3 Cabling requirements.9 6. IEEE 11073-30400 feature group definition.10 6.1 Section-level summary.10 6.2 Clause/annex level mapping.10 Annex A (informative) Bibliography.30 Annex B (informative) fEEE list of participants.31 SIST EN ISO 11073-30400:2013

ISO/IEEE 11073-30400:2012(E) iv © ISO 2012 – All rights reserved© IEEE 2012 – All rights reserved Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. IEEE Standards documents are developed within the IEEE Societies and the Standards Coordinating Committees of the IEEE Standards Association (IEEE-SA) Standards Board. The IEEE develops its standards through a consensus development process, approved by the American National Standards Institute, which brings together volunteers representing varied viewpoints and interests to achieve the final product. Volunteers are not necessarily members of the Institute and serve without compensation. While the IEEE administers the process and establishes rules to promote fairness in the consensus development process, the IEEE does not independently evaluate, test, or verify the accuracy of any of the information contained in its standards. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is called to the possibility that implementation of this standard may require the use of subject matter covered by patent rights. By publication of this standard, no position is taken with respect to the existence or validity of any patent rights in connection therewith. ISO/IEEE is not responsible for identifying essential patents or patent claims for which a license may be required, for conducting inquiries into the legal validity or scope of patents or patent claims or determining whether any licensing terms or conditions provided in connection with submission of a Letter of Assurance or a Patent Statement and Licensing Declaration Form, if any, or in any licensing agreements are reasonable or non-discriminatory. Users of this standard are expressly advised that determination of the validity of any patent rights, and the risk of infringement of such rights, is entirely their own responsibility. Further information may be obtained from ISO or the IEEE Standards Association. ISO/IEEE 11073-30400 was prepared by the IEEE 11073 Standards Comittee of the IEEE Engineering in Medicine and Biology Society (as IEEE Std 11073-30400-2010). It was adopted by Technical Committee ISO/TC 215, Health informatics, in parallel with its approval by the ISO member bodies, under the “fast-track procedure” defined in the Partner Standards Development Organization cooperation agreement between ISO and IEEE. IEEE is responsible for the maintenance of this document with participation and input from ISO member bodies. ISO/IEEE 11073 consists of the following parts, under the general title Health informatics — Personal health device communication (text in parentheses gives a variant of subtitle):  Part 10101: (Point-of-care medical device communication) Nomenclature  Part 10201: (Point-of-care medical device communication) Domain information model  Part 10404: Device specialization — Pulse oximeter  Part 10407: Device specialization — Blood pressure monitor  Part 10408: Device specialization — Thermometer  Part 10415: Device specialization — Weighing scale SIST EN ISO 11073-30400:2013

ISO/IEEE 11073-30400:2012(E) © ISO 2012 – All rights reserved © IEEE 2012 – All rights reserved v  Part 10417: Device specialization — Glucose meter  Part 10420: Device specialization — Body composition analyzer  Part 10421: Device specialization — Peak expiratory flow monitor (peak flow)  Part 10471: Device specialization — Independant living activity hub  Part 10472: Device specialization — Medication monitor  Part 20101: (Point-of-care medical device communication) Application profiles — Base standard  Part 20601: Application profile — Optimized exchange protocol  Part 30200: (Point-of-care medical device communication) Transport profile — Cable connected  Part 30300: (Point-of-care medical device communication) Transport profile — Infrared wireless  Part 30400: (Point-of-care medical device communication) Interface profile — Cabled Ethernet  Part 90101: (Point-of-care medical device communication) Analytical instruments — Point-of-care test  Part 91064: (Standard communication protocol) Computer-assisted electrocardiography  Part 92001: (Medical waveform format) — Encoding rules
ISO/IEEE 11073-30400:2012(E) vi © ISO 2012 – All rights reserved© IEEE 2012 – All rights reserved
Introduction This introduction is not part of IEEE Std 11073-30400-2010, Health informatics—Point-of-Care medical device communication—Part 30400: Interface profile—Cabled Ethernet. ISO/IEEE 11073 standards enable communication between medical devices and external computer systems. They provide automatic and detailed electronic data capture of patient vital signs information and device operational data. The primary goals are as follows: ⎯ To provide real-time plug-and-play interoperability for patient-connected medical devices ⎯ To facilitate the efficient exchange of vital signs and medical device data, acquired at the PoC, in all health care environments “Real time” means that data from multiple devices can be retrieved, time correlated, and displayed or processed in fractions of a second. “Plug and play” means that all the clinician has to do is make the connection between devices. The devices automatically detect, configure, and initiate communication without any other human interaction. “Efficient exchange of medica
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