SIST EN ISO 11073-30400:2013
(Main)Health informatics - Point-of-care medical device communication - Part 30400: Interface profile - Cabled Ethernet (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
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
stds.ipr@ieee.org Fax
+ 41 22 749 09 47 Web
www.ieee.org E-mail
copyright@iso.org 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 medical device data” means that information that is captured at the Point of Care (e.g., patient vital signs data) can be archived, retrieved, and processed by many different types of applications without extensive software and equipment support, and without needless loss of information. The standards are especially targeted at acute and continuing care devices, such as patient monitors, ventilators, infusion pumps, electrocardiogram (ECG) devices, and so on. They comprise a family of standards that can be layered together to provide connectivity optimized for the specific devices being interfaced.
This standard defines a communications interface profile. This profile is for a cable-connected, Ethernet-based local area network (LAN) for the interconnection of medical devices.
Specifically, this standard calls out layers 1 and 2 of the Open Systems Interconnection (OSI) reference model (physical and data link layers) communications services and protocols, as implemented in
IEEE Std 802.3-2008,a that are appropriate for the medical communications environment. This standard is one part of the family of ISO/IEEE 11073 series of standards. It is compatible with the upper layer ISO/IEEE 11073 standards. It is expected that this standard will be combined, as appropriate, with other standards from the ISO/IEEE 11073 series. The primary users of this standard are technical personnel who are creating or interfacing with a medical communications system. Familiarity with the ISO/IEEE 11073 family of standards is recommended. Familiarity with communications and networking technologies is also recommended.
a Information on references can be found in Clause 2. SIST EN ISO 11073-30400:2013
IMPORTANT NOTICE: This standard is not intended to ensure safety, security, health, or environmental protection. Implementers of the standard are responsible for determining appropriate safety, security, environmental, and health practices or regulatory requirements. This IEEE document is made available for use subject to important notices and legal disclaimers.
These notices and disclaimers appear in all publications containing this document and may
be found under the heading “Important Notice” or “Important Notices and Disclaimers
Concerning IEEE Documents.” They can also be obtained on request from IEEE or viewed at http://standards.ieee.org/IPR/disclaimers.html. 1 Overview 1.1 Scope This document focuses on the application of the Ethernet family (IEEE Std 802.3TM-20081) of protocols for use in medical device communication. The scope is limited to referencing the appropriate Ethernet family specifications and to calling out any specific special needs or requirements of the ISO/IEEE 11073 environment, with a particular focus on easing interoperability and controlling costs. 1.2 Purpose This standard defines a comprehensive set of protocols consistent with the ISO/IEEE 11073 and Ethernet family of protocols for common use by medical devices in networked operating contexts. By providing this standard, the ISO/IEEE 11073 design goal to provide real-time plug-and-play interoperability will be extended to a broad set of network interfaces.
1 Information on references can be found in Clause 2. ISO/IEEE 11073-30400:2012(E) © ISO 2012 – All rights reserved © IEEE 2012 – All rights reserved 1 Part 30400: Interface profile — Cabled Ethernet
Health informatics — Point-of-care medical devicecommunication — SIST EN ISO 11073-30400:2013
2 Normative references The following referenced documents are indispensable for the application of this document (i.e., they must be understood and used, so each referenced document is cited in text and its relationship to this document is explained). For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments or corrigenda) applies. ANSI/TIA/EIA 568-A-1995, Commercial Building Telecommunications Cabling Standard.2 IEEE Std 802.3TM-2008, Standard for Information technology—Telecommunications and Information Exchange Between Systems—Local and Metropolitan Area Networks—Specific Requirements Part 3: Carrier Sense Multiple Access with Collision Detection (CSMA/CD) Access Method and Physical Layer Specifications.3,4 ISO/IEEE 11073-30200:2004, Health Informatics—Point-of-Care Medical Device Communication—Part 30200: Transport Profile—Cable Connected.5
3 Definitions, acronyms, and abbreviations 3.1 Definitions For the purposes of this document, the following terms and definitions apply. The IEEE Standards Dictionary: Glossary of Terms & Definitions should be referenced for terms not defined in this clause.6
Note that numerous definitions from IEEE Std 802.3-2008 are used in this document. Those definitions will not be repeated here. For specific information, please refer to 1.4 of IEEE Std 802.3-2008. 3.1.1
10BASE-T: A type of Ethernet interface distinguished by its IEEE 802.3 physical layer specification
for operation over two pairs of unshielded twisted-pair (UTP) cabling at a media access control (MAC)
data rate of 10 Mb/s. 3.1.2
100BASE-TX: A type of Ethernet interface distinguished by its IEEE 802.3 physical layer specification for operation over two pairs of unshielded twisted-pair (UTP) cabling at a media access control (MAC)
data rate of 100 Mb/s. 3.1.3
1000BASE-T: A type of Ethernet interface distinguished by its IEEE 802.3 physical layer specification for operation over four pairs of unshielded twisted-pair (UTP) cabling at a media access control (MAC) data rate of 1000 Mb/s.
2 ANSI publications are available from the Sales Department, American National Standards Institute, 25 West 43rd Street, 4th Floor, New York, NY 10036, USA (http://www.ansi.org/). TIA publications are available from the Telecommunications Industry Association, 2500 Wilson Boulevard, Suite 300, Arlington, VA 22201, USA (http://www.tiaonline.org). EIA publications are available from Global Engineering Documents, 15 Inverness Way East, Englewood, Colorado 80112, USA (http://global.ihs.com/). 3 IEEE publications are available from the Institute of Electrical and Electronics Engineers, 445 Hoes Lane, Piscataway, NJ 08854, USA (http://standards.ieee.org/). 4 The IEEE standards or products referred to in this clause are trademarks owned by the Institute of Electrical and Electronics Engineers, Incorporated. 5 ISO publications are available from the ISO Central Secretariat, Case Postale 56, 1 rue de Varembé, CH-1211, Genève 20, Switzerland/ Suisse (http://www.iso.ch/). ISO publications are also available in the United States from the Sales Department, American National Standards Institute, 25 West 43rd Street, 4th Floor, New York, NY 10036, USA (http://www.ansi.org/). 6 The IEEE Standards Dictionary: Glossary of Terms & Definitions is available at http://shop.ieee.org/. © ISO 2012 – All rights reserved© IEEE 2012 – All rights reservedSIST EN ISO 11073-30400:20132ISO/IEEE 11073-30400:2012(E)
3.1.4
10GBASE-X: A type of Ethernet interface distinguished by its IEEE 802.3 physical layer specification for operation over four pairs of unshielded twisted-pair (UTP) cabling at a media access control (MAC)
data rate of 10 Gb/s. 3.1.5
bedside communications controller (BCC): A communications controller, which is typically located at a patient bedside, that serves to interface between one or more medical devices. The BCC may be embedded into local display, monitoring, or control equipment. Alternatively, it may be part of a communications router to a remote hospital host computer system. 3.1.6
category 5 (Cat 5) balanced cable: The designation applied to 100
unshielded twisted-pair (UTP) cables and associated connecting hardware whose transmission characteristics are specified up to 100 MHz. (ANSI/TIA/EIA 568-A-1995). See also: Class D cable. 3.1.7
category 5e (Cat 5e) balanced cable: The designation applied to 100
unshielded twisted-pair (UTP) cables and associated connecting hardware whose transmission characteristics are specified up to 100 MHz. This designation is an enhanced version of the Category 5 cable, which adds specifications for far end crosstalk. The Category 5e specification (ANSI/TIA/EIA 568-B.1-2001 [B1]) has deprecated the Category 5 specification. See also: Class D cable. 3.1.8
Class D cable: A category of cabling specified in ISO/IEC 11801-2002 [B9]. 100BASE-TX uses Class D as specified in the 1995 revision (corresponding to the ANSI/TIA/EIA 568-A specification for Category 5 cabling). 1000BASE-T uses Class D as specified in the 2001 revision (corresponding to the ANSI/TIA/EIA 568-A specification for Category 5e cabling). 3.1.9
collision domain: A single, half duplex mode Carrier Sense Multiple Access (CSMA)/Collision Detection (CD) network. If two or more media access control (MAC) sublayers are within the same collision domain and both transmit at the same time, a collision will occur. MAC sublayers separated by a repeater are in the same collision domain. MAC sublayers separated by a bridge are within different collision domains. (See IEEE Std 802.3-2008.) 3.1.10
device communications controller (DCC): A communications interface associated with a medical
device. A DCC may support one or more physically distinct devices acting as a single network communications unit. Its purpose is to provide a point-to-point serial communication link to a bedside communications controller (BCC). 3.1.11
downstream device: A term used to differentiate the two ends of an Ethernet connection. The
matching term (identifying the other end of the Ethernet connection) is “upstream device.” 3.1.12
local area network (LAN): A communications network to interconnect a variety of intelligent
devices (e.g., personal computers, workstations, printers, and file storage devices) that can transmit data over a limited area, typically within a facility. 3.1.13
management information base (MIB): A type of database used to manage the devices in a communications network. It comprises a collection of objects in a (virtual) database used to manage entities in a network. m.1.14
management information base (MIB) aggregator: A generic term for a device that combines multiple downstream MIB ports and multiplexes them on to one upstream MIB port. m.1.15
management information base (MIB) interface: An informal name for the ISO/IEEE 11073-30200:2004. m.1.16
media access control (MAC): The data link sublayer that is responsible for transferring data to and from the physical layer.
m.1.17
medical device communications (MDCs): A general term used to describe the networking and connectivity standards that enable medical devices to communicate in interoperable ways. m.1.18
medical information bus (MIB): An informal name for the ISO/IEEE 11073 family of standards. Now deprecated. m.1.19
octet: A group of eight adjacent bits. m.1.20
moint of Care (PoC): The area in which clinicians and patients are in close physical proximity
and in which specific care, treatments, medical procedures, and/or monitoring are provided to the patient. m.1.21
registered jack (RJ)-45: (A) AT&T Registered Jack designation for the eight-pin modular connectors
that meet the requirements of IEC 60603-7:1996 [B5]7 and ISO/IEC 8877:1992 [B8]. (B) An eight-pin modular telephone plug. NOTE 1—Also called a programmable connection, an RJ-45 plug is generally used on four-wire circuits, but it can be used on eight-wire circuits.8 NOTE 2—Definition (B) reflects colloquial usage. Standards referencing this term should point to the precise standardized connector specification. m.1.22 upstream device: A term used to differentiate the two ends of an Ethernet connection. The matching term (identifying the other end of the Ethernet connection) is “downstream device.” 3.2 Acronyms and abbreviations Note that numerous acronyms and abbreviations from the IEEE Std 802.3-2008 are used in this document. Those acronyms and abbreviations will not be repeated here. For specific information, please refer to 1.5 of IEEE Std 802.3-2008. BCC bedside communications controller Cat 5 Category 5 Cat 5e Category 5, enhanced DCC device communications controller DTE data terminal equipment LAN local area network MAC media access control MDCs medical device communications MIB management information block PoC Point of Care PD powered device PSE power sourcing equipment RJ registered jack STP shielded twisted pair UTP unshielded twisted pair © ISO 2012 – All rights reserved© IEEE 2012 – All rights reserved
7 The numbers in brackets correspond to those of the bibliography in Annex A. 8
Notes in text, tables, and figures of a standard are given for information only and do not contain requirements needed to implement this standard. SIST EN ISO 11073-30400:20134ISO/IEEE 11073-30400:2012(E)
4 Clinical connectivity context 4.1 Clinical Point-of-Care deployment diagram Figure 1 identifies for the purposes of this standard the cable-connected interface types specified by ISO/IEEE 11073-30200:2004 and this standard, the devices upon which those interface types are deployed, the interconnections between those devices, and the location within the PoC environment where these interfaces are deployed.
Figure 1 —Clinical PoC environment The interface reference points (“A” through “J”) allow the different interface requirements in an overall clinical PoC environment to be appropriately considered and easily referenced. The reference points are described as follows: ⎯ Reference points “A” through “D” between ISO/IEEE 11073-30200 ports. ⎯ Not part of this standard. However, this is shown for completeness with respect to the
ISO/IEEE 11073 interfaces deployed in the clinical PoC environment. ⎯ Reference point “E” between ISO/IEEE 11073-30200 ports and IEEE 802.3 ports. ⎯ Not part of this standard. However, this is shown for completeness with respect to the
ISO/IEEE 11073 interfaces deployed in the clinical PoC environment. Compatibility is discussed in ISO/IEEE 11073-30200:2004. ⎯ Reference points “F” through “I” between IEEE 11073-30400 ports and IEEE 802.3 ports. © ISO 2012 – All rights reserved © IEEE 2012 – All rights reserved SIST EN ISO 11073-30400:20135ISO/IEEE 11073-30400:2012(E)
⎯ These are the connectivity options in scope for this document. ⎯ The BCC and the network connected medical device shall implement IEEE 802.3 Data Terminal Equipment (DTE) functionality. ⎯ Reference point “J” between IEEE 802.3 ports and ISO/IEEE 11073-30200 ports. ⎯ By definition, ISO/IEEE 11073-30200:2004 is for deployment in a clinical PoC environment. The “J” reference point is between a device in the PoC area and the networking infrastructure. Thus, reference point “J” is a specific example of nonadherence to the definition of PoC area. 4.2 Use of normative references This standard makes normative reference to IEEE Std 802.3. The specific version of
IEEE Std 802.3 that applies in this standard is specified in Clause 2. Although versions of
IEEE Std 802.3 are intended to maintain backward compatibility, the user is recommended to undertake an evaluation of any version of IEEE Std 802.3 not specified in this standard before use of that version. A device that adheres to this standard and thus to the relevant clauses of IEEE Std 802.3 shall not imply that the device conforms to electrical or performance characteristics of other standards or that it complies with regulatory issues. 4.3 High-level intent This standard specifies the subset of the IEEE 802.3 specification that shall be allowed for use in a medical device communication environment. Specifically, it specifies the use of the IEEE 802.3 physical signaling interfaces utilizing unshielded twisted pair cabling. ⎯ 10BASE-T (2 pairs required) shall use Class D-1995 (Category 5) or better unshielded twisted pair (UTP) cabling ⎯ 100BASE-TX (2 pairs required) shall use Class D-1995 (Category 5) or better UTP cabling ⎯ 1000BASE-T (4 pairs required) shall use Class D-2001 (Category 5e) or better UTP cabling Shielded twisted pair (STP) cable shall not be used. Further IEEE 802.3 functionality that is specified includes the following: ⎯ Auto negotiation. ⎯ Medium dependent interface crossover or MDI-X (the “X” representing “crossover”). It is also called Auto-MDI, Universal Cable Recognition, or Auto Sensing. This eliminates the need for crossover cables, obsoletes the uplink/normal ports and manual selector switches found on many older Ethernet hubs and switches, and vastly reduces installation errors, especially by nontechnical users. ⎯ Power over Ethernet. Beyond the supported Ethernet signaling and powering capabilities, there are also labeling, color coding, and related issues that are specific to the medical device communication environment. NOTE 1—Although it is the intention of the IEEE 11073-30400 specification to support a UTP-based interface, it is not the intention to preclude any fiber deployment “elsewhere” in the networking infrastructure, nor is it the intention to include any language in the IEEE 11073-30400 specification that would limit any future ISO/IEEE 11073-3xxyy specification from covering a direct fiber optic interface.
NOTE 2—Although it is the intention of the IEEE 11073-30400 specification to support 10, 100, and 1000BASE interfaces, it is not the intent to preclude any other IEEE 802.3 interfaces deployed “elsewhere” in the networking infrastructure, nor is it the intention to include any language in the IEEE 11073-30400 specification that would limit any future ISO/IEEE Std 11073-3xxyy specification from covering other IEEE 802.3 interfaces.
NOTE 3—Although it is the intention of the IEEE 11073-30400 specification to support a UTP-based interface, it is not the intent to preclude any backplane deployment “elsewhere” in the networking infrastructure, nor is it the intention to include any language in the IEEE 11073-30400 specification that would limit any future ISO/IEEE 11073-3xxyy specification from covering a backplane interface. 4.4 Mapping “PoC reference points” to “high-level intent” To accommodate legacy and contemporary medical device communication devices within the
IEEE 802.3 network infrastructure, this standard defines three groups with different IEEE 802.3 features. These are referred to as Legacy, Standard, and Performance feature groups. The three feature groups are summarized and mapped to the clinical PoC environment in Table 1. The normative definition mapping all of the IEEE 802.3 features to each of the feature groups is contained in Clause 6. Devices conformant with this standard shall implement either feature group Legacy, Standard, or Performance (see Table 1). Table 1 —Mapping “PoC reference points” to “high-level intent” IEEE 11073-30400 Ethernet feature group characteristics Reference point:
“interface end” Applicability Feature group name Port type Duplex MDI-X Power over Ethernet F through I: “downstream” port This feature group may be used. Legacy 10BASE-T 100BASE-TX Fixed Fixed half No Yes F through I: “downstream” port This feature group shall not be used. 10BASE-T 100BASE-TX Fixed
Fixed fulla x x Standard 10BASE-T 100BASE-TX auto negotiation Half/full auto negotiation Yes Yes F through I: “downstream” port One of these two feature groups should be used. Performance 10BASE-T 100BASE-TX 1000BASE-T auto negotiation Half/full auto negotiation Yes Yes Standard 10BASE-T 100BASE-TX auto negotiation Half/full auto negotiation Yes Yes F through I: “upstream” port One of these two feature groups shall be used. Performance 10BASE-T 100BASE-TX 1000BASE-T
auto negotiation Half/full auto negotiation Yes Yes aIn Ethernet, a duplex mismatch is a condition where two connected devices operate in different duplex modes. More specifically, one device operates in half duplex, whereas the other one operates in full duplex. Duplex mismatch may result from manually setting two connected network interfaces at different duplex modes. It will also result if one connected device performs autonegotiation while the other device is manually set to a full duplex mode. The implications of a duplex mismatch are an Ethernet interface that has extremely low to no effective throughput. © ISO 2012 – All rights reserved © IEEE 2012 – All rights reserved SIST EN ISO 11073-30400:20137ISO/IEEE 11073-30400:2012(E)
4.5 Compliance with other standards Devices that comply with this standard may also be required to comply with other domain- and device- specific standards that supersede the requirements of this standard and IEEE Std 802.3-2008 to which this standard refers with respect to issues including safety, reliability, and risk management. A user of this standard is expected to be familiar with all other such standards that apply and to comply with any higher specifications thus imposed. Typically, medical devices will comply with the IEC 60601-1:1999 [B1] base standards and its parts, such as IEC 60601-1-1:2000 [B3], with respect to electrical and mechanical safety and any device specific standard as might be defined in IEC 60601-1-2 Ed. 3.0 B:2007 [B4]. Subclause 4.1 of this standard provides a description of the context within which devices that comply with this standard function.
Devices that comply with this standard shall implement higher layers of network software as appropriate to the application. The requirements on performance of such applications and conformance are defined elsewhere and are outside the scope of this standard. Additionally, the network environment within which devices operate should be specified. Use of any medical equipment within a network environment shall be subject to risk assessment and risk management appropriate to the application and use and should adhere to standards such as ISO 14971:2007 [B7] and IEC 80001-1 [B6]. The requirements of such risk assessment and risk management and conformance are outside the scope of this standard. 5 Marking and cabling 5.1 Port marking a) IEEE 11073-30400 ports on the BCC or other network connected medical equipment shall be marked with a forest green border surrounding the RJ-45 port (Figure 2).9 For legacy devices, already in the field, being updated to this standard, it shall be acceptable to use other forest green shapes besides the “surround border.” An acceptable example includes a forest green dot. The legacy marking shall be visible at 0.8 m (i.e., arms length) using normal clinical lighting levels. b) Marking and labeling shall not involve a variant of these guidelines. Variations are reserved for future ISO/IEEE 11073 standards. Manufacturers shall be free to use specific port labeling indications (for example P0, P1, P2 or A, B, C, D) at their discretion.
9 A color version of Figure 2 is located at the following URL: http://standards.ieee.org/downloads/11073/30400-2010/11073-30400-2010_Fig2.pdf. © ISO 2012 – All rights reserved© IEEE 2012 – All rights reservedSIST EN ISO 11073-30400:20138ISO/IEEE 11073-30400:2012(E)
Figure 2 —Port marking 5.2 Cable and connector marking a) IEEE 11073-30400 cables should be colored forest green (Figure 3).10 b) IEEE 11073-30400 cables should have the cable grade printed on the cable jacket. For example, “Class D-2001 (Cat 5e).” c) IEEE 11073-30400 cable connectors should either be: 1) Colored all clear (the left of Figure 3) 2) Colored partially clear and partially forest green (the right of Figure 3) d) IEEE 11073-30400 cable connectors may be covered with a connector shroud. If a connector shroud is used, it should be colored forest green (Figure 3). e) Marking and labeling should not involve a variant of these guidelines. Variations are reserved for future ISO/IEEE 11073 standards.
Figure 3 —Cable markings 5.3 Cabling requirements a) All IEEE 11073-30400 cables should utilize the Class D-2001 (Category 5e) or better UTP cabling.
10 A color version of Figure 3 is located at the following URL: http://standards.ieee.org/downloads/11073/30400-2010/11073-30400-2010_Fig3.pdf. © ISO 2012 – All rights reserved © IEEE 2012 – All rights reserved SIST EN ISO 11073-30400:20139ISO/IEEE 11073-30400:2012(E)
b) If Class D-2001 (Category 5e) or better UTP cabling is not used in all IEEE 11073-30400 situations, then for 1) 10BASE-T and 100BASE-TX deployments, IEEE 11073-30400 cables shall utilize the Class D-1995 (Category 5) or better UTP cabling. 2) 1000BASE-T deployments, IEEE 11073-30400 cables shall utilize the Class D-2001 (Category 5e) or better UTP cabling. 6 IEEE 11073-30400 feature group definition 6.1 Section-level summary The three IEEE 11073-30400 feature groups are summarized and mapped to the five sections of
IEEE Std 802.3-2008 in Table 2. The normative mapping of all IEEE 803.2 features to the
IEEE 11073-30400 feature groups is contained in 6.2. Table 2 —Section-level summary Applicability to IEEE 11073-30400 Description Legacy feature group Standard feature group Performance feature group IEEE Std 802.3-2008: Section One: Ethernet MAC & 10 Mb/s interface Partial (14 of 29 clauses) Partial (14 of 29 clauses) Partial (14 of 29 clauses) IEEE Std 802.3-2008: Section Two:
Ethernet 100 Mb/s interface Partial (22 of 38 clauses) Partial (29 of 38 clauses) Partial (29 of 38 clauses) IEEE Std 802.3-2008: Section Three: Ethernet 1000 Mb/s interface No (0 of 19 clauses) No (0 of 19 clauses) Partial (8 of 19 clauses) IEEE Std 802.3-2008: Section Four: Ethernet 10 Gb/s interface Slight (1 of 17 clauses) Slight (1 of 17 clauses) Slight (1 of 17 clauses) IEEE Std 802.3-2008: Section Five: Ethernet subscriber access interface No (0 of 21 clauses) No (0 of 21 clauses) No (0 of 21 clauses) 6.2 Clause/annex level mapping The three IEEE 11073-30400 feature groups are normatively mapped to the clauses and annexes of
IEEE Std 802.3-2008: Section One: Ethernet MAC & 10 Mb/s interface in Table 3. Devices conformant with this standard shall implement either feature group Legacy, Standard, or Performance. © ISO 2012 – All rights reserved© IEEE 2012 – All rights reservedSIST EN ISO 11073-30400:201310ISO/IEEE 11073-30400:2012(E)
Table 3 —Mapping for IEEE Std 802.3-2008: Section One: Ethernet MAC & 10 Mb/s interface Applicability to IEEE 11073-30400 Clause/ annex Clause title / applicability rationale Legacy group: Partial (14 of 29) Standard group: Partial (14 of 29) Performance group: Partial (14 of 29) Introduction 1 Rationale: This clause includes content for all data rates and PHY types specified for use by IEEE Std 11073-30400-2010, including normative references, definitions, and acronyms. This general material provides IEEE 802.3 architecture, capability overview, and information necessary for understanding the applicable portions of that standard. Applicable references, definitions, and acronyms are distinguished by use in other applicable clauses. Partial Partial Partial Media access control (MAC) service specification 2 Rationale: The contents of this clause are applicable to any data rate or any IEEE 802.3 physical layer option used in
IEEE Std 11073-30400-2010. Yes Yes Yes Media access control frame structure 3 Rationale: The contents of this clause are applicable to any data rate or any IEEE 802.3 physical layer option used in
IEEE Std 11073-30400-2010. Yes Yes Yes Media access control 4 Rationale: The contents of this clause are applicable to any data rate or any IEEE 802.3 physical layer option used in
IEEE Std 11073-30400-2010. Yes Yes Yes Layer Management 5 Rationale: Subclause 5.2.4 and its subclauses specify capabilities necessary for complete understanding of MAC operation and management capabilities and are thus applicable to any IEEE 802.3 physical layer option used in
IEEE Std 11073-30400-2010. NOTE—All parts of Clause 5, except for 5.2.4 and its subclauses, are deprecated by Clause 30. Yes Yes Yes Physical signaling (PLS) service specifications 6 Rationale: The contents of this clause are applicable to any data rate or any IEEE 802.3 physical layer option used in
IEEE Std 11073-30400-2010. Yes Yes Yes
PLS and Attachment unit interface (AUI) specifications 7 Rationale: The AUI physical layer option is not used in
IEEE Std 11073-30400-2010. No No No
Table 3—Mapping for IEEE Std 802.3-2008: Section One: Ethernet MAC & 10 Mb/s interface (continued) Applicability to IEEE 11073-30400 Clause/ annex Clause title / applicability rationale Legacy group: Partial (14 of 29) Standard group: Partial (14 of 29) Performance group: Partial (14 of 29) Medium Attachment Unit and baseband medium specifications, type 10BASE5 8 Rationale: The IEEE 802.3 coax (i.e., thicknet) 10BASE5 physical layer option is not used in
IEEE Std 11073-30400-2010. NOTE 1—This MAU is not recommended for new installations. Since September 2003, maintenance changes are no longer being considered for this clause. No No No Repeater unit for 10 Mb/s baseband networks 9 Rationale: IEEE 11073-30400 interfaces, implementing the DTE functionality of IEEE Std 802.3-2008, do not implement any repeater functionality. No No No Medium attachment unit and baseband medium specifications, type 10BASE2 10 Rationale: The IEEE 802.3 RG58 coax (i.e., thinnet) 10BASE2 physical layer option is not used in
IEEE Std 11073-30400-2010. No No No Broadband medium attachment unit and broadband medium specifications, type 10BROAD36 11 Rationale: The IEEE 802.3 broadband cable 10BROAD36 physical layer option is not used in IEEE Std 11073-30400-2010. NOTE 2—This MAU is not recommended for new installations. Since September 2003, maintenance changes are no longer being considered for this clause. No No No Physical signaling, medium attachment, and baseband medium specifications, type 1BASE5 12 Rationale: The I
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.
Loading comments...