EN ISO 11073-30200:2005/A1:2015

Health informatics - Point-of-care medical device communication - Part 30200: Transport profile - Cable connected - Amendment 1 (ISO/IEEE 11073-30200:2004/Amd 1:2015)

2014-03-04 GVN: Draft for minor revision received in ISO/CS (see notification of 2014-03-03 in dataservice).

Medizinische Informatik - Kommunikation patientennaher medizinischer Geräte - Teil 30200: Transportprofil - Drahtgebundene Übertragung - Änderung 1 (ISO/IEEE 11073-30200:2004/Amd 1:2015)

Informatique de santé - Communication entre dispositifs médicaux sur le site des soins - Partie 30200: Profil de transport - Connexion par câble - Amendement 1 (ISO/IEEE 11073-30200:2004/Amd 1:2015)

Zdravstvena informatika - Komunikacija medicinskih naprav na mestu oskrbe - 30200. del: Transportni profil - Kabelsko priključen - Dopolnilo 1 (ISO/IEEE 11073-30200:2004/Amd 1:2015)

General Information

• Status: Published
• Publication Date: 22-Sep-2015
• Withdrawal Date: 30-Mar-2016
• ICS: 35.100.40 - Transport layer
• 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: 23-Sep-2015
• Completion Date: 23-Sep-2015
• Ref Project: SIST EN ISO 11073-30200:2005/A1:2015 - Health informatics - Point-of-care medical device communication - Part 30200: Transport profile - Cable connected - Amendment 1 (ISO/IEEE 11073-30200:2004/Amd 1:2015)

Relations

• Amends: EN ISO 11073-30200:2005 - Health informatics - Point-of-care medical device communication - Part 30200: Transport profile - Cable connected (ISO/IEEE 11073-30200:2004)
• Effective Date: 05-Mar-2014

Overview

EN ISO 11073-30200:2005/A1:2015 is an amendment to the point-of-care medical device communication transport profile for cable-connected devices. Adopted by CEN in 2015, this amendment extends ISO/IEEE 11073-30200:2004 to explicitly include IEEE 802.3 100BASE-T (Fast Ethernet) and supplies an analysis of cable-connection compatibility between ISO/IEEE 11073-30200 and IEEE Std 802.3-2008. The document supports reliable wired bedside and clinical connectivity for medical devices and is part of the ISO/IEEE 11073 family addressing medical device interoperability.

Key topics and technical focus

• Transport profile - Cable connected: Defines transport-level considerations for wired point-of-care device communication (the amendment updates/adds details relevant to cable-based links).
• IEEE 802.3 100BASE-T inclusion: Extension to support 100 Mbps Ethernet (100BASE-T) as a transport medium for ISO/IEEE 11073-30200 systems.
• Compatibility analysis: Examines interoperability and cable-connection compatibility between existing ISO/IEEE 11073-30200 implementations and IEEE 802.3 (2008) Ethernet standards.
• Interoperability considerations: Addresses legacy device integration, media translation (e.g., IrDA to wired), and networked bedside device behavior (keywords referenced in the amendment include MIB, SNTP, legacy device, IrDA).
• Standards coordination: Harmonizes IEEE and ISO provisions for wired transport in clinical environments; notes potential patent and regulatory considerations.

Practical applications

• Bedside device connectivity: Use for wired communication of patient monitors, infusion pumps, ventilators and other point-of-care equipment to clinical gateways or hospital networks.
• Device and network design: Guidance for biomedical engineers and device manufacturers implementing Ethernet 100BASE-T interfaces that must comply with ISO/IEEE 11073 transport expectations.
• Interoperability testing & integration: Reference for integrators and test labs verifying cable compatibility and behavior between medical device endpoints and hospital Ethernet infrastructure.
• Legacy migration: Helps plan migration paths from proprietary or infrared (IrDA) links to standardized wired Ethernet connections while preserving ISO/IEEE 11073 semantics.

Who should use this standard

• Medical device manufacturers and firmware/network engineers
• Hospital IT, clinical engineering and biomedical teams
• Systems integrators and interoperability test laboratories
• Standards bodies and regulatory professionals focused on medical device communication

Related standards

• ISO/IEEE 11073 family (point-of-care device communication)
• IEEE Std 802.3-2008 (Ethernet)
• Standards on MIBs and time synchronization (SNTP) referenced in interoperability analysis

Keywords: ISO 11073-30200, EN ISO 11073-30200:2005/A1:2015, IEEE 802.3 100BASE-T, point-of-care medical device communication, transport profile, cable connected, medical device interoperability, bedside connectivity.

Standards Content (Sample)

SLOVENSKI STANDARD
01-december-2015
=GUDYVWYHQDLQIRUPDWLND.RPXQLNDFLMDPHGLFLQVNLKQDSUDYQDPHVWXRVNUEH
GHO7UDQVSRUWQLSURILO.DEHOVNRSULNOMXþHQ'RSROQLOR,62,(((
$PG
Health informatics - Point-of-care medical device communication - Part 30200: Transport
profile - Cable connected - Amendment 1 (ISO/IEEE 11073-30200:2004/Amd 1:2015)
Medizinische Informatik - Kommunikation patientennaher medizinischer Geräte - Teil
30200: Transportprofil - Drahtgebundene Übertragung - Änderung 1 (ISO/IEEE 11073-
30200:2004/Amd 1:2015)
Informatique de santé - Communication entre dispositifs médicaux sur le site des soins -
Partie 30200: Profil de transport - Connexion par câble - Amendement 1 (ISO/IEEE
11073-30200:2004/Amd 1:2015)
Ta slovenski standard je istoveten z: EN ISO 11073-30200:2005/A1:2015
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.

EN ISO 11073-
EUROPEAN STANDARD
30200:2005/A1
NORME EUROPÉENNE
EUROPÄISCHE NORM
September 2015
ICS 35.240.80
English Version
Health informatics - Point-of-care medical device
communication - Part 30200: Transport profile - Cable
connected - Amendment 1 (ISO/IEEE 11073-
30200:2004/Amd 1:2015)
Informatique de santé - Communication entre Medizinische Informatik - Kommunikation
dispositifs médicaux sur le site des soins - Partie patientennaher medizinischer Geräte - Teil 30200:
30200: Profil de transport - Connexion par câble - Transportprofil - Drahtgebundene Übertragung -
Amendement 1 (ISO/IEEE 11073-30200:2004/Amd Änderung 1 (ISO/IEEE 11073-30200:2004/Amd
1:2015) 1:2015)
This amendment A1 modifies the European Standard EN ISO 11073-30200:2005; it was approved by CEN on 13 September 2015.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of
this amendment into the relevant 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 amendment 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

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11073-30200:2005/A1:2015 E
worldwide for CEN national Members.

Contents Page
European foreword.3

European foreword
The text of ISO 11073-30200:2004/Amd1:2015 has been prepared by Technical Committee ISO/TC 215
“Health informatics” of the International Organization for Standardization (ISO) and has been taken
over as EN ISO 11073-30200:2005/A1:2015 by Technical Committee CEN/TC 251 “Health informatics”
the secretariat of which is held by NEN.
This Amendment to the European Standard EN ISO 11073-30200:2005 shall be given the status of a
national standard, either by publication of an identical text or by endorsement, at the latest by March
2016, and conflicting national standards shall be withdrawn at the latest by March 2016.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: 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 the United Kingdom.
Endorsement notice
The text of ISO 11073-30200:2004/Amd 1:2015 has been approved by CEN as EN ISO 11073-
30200:2005/A1:2015 without any modification.
INTERNATIONAL ISO/IEEE
STANDARD 11073-30200
First edition
2004-12-15
AMENDMENT 1
2015-03-01
Health informatics — Point-of-care
medical device communication —
Part 30200:
Transport profile — Cable connected
AMENDMENT 1
Informatique de santé — Communication entre dispositifs médicaux sur
le site des soins —
Partie 30200: Profil de transport — Connexion par câble
AMENDEMENT 1
Reference number
ISO/IEEE 11073-30200:2004/Amd 1:2015(E)

©
IEEE 2004
ISO/IEEE 11073-30200:2004/Amd 1:2015(E)

©  IEEE 2015
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
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ISO/IEEE 11073-30200:2004/Amd.1:2015(E)
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ISO/IEEE 11073-30200:2004/Amd.1:2015(E)
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iv © IEEE 2004 – All rights reserved

Health informatics—Point-of-care medical device communication

Part 30200: Transport profile—
Cable connected
Amendment 1
IEEE Engineering in Medicine and Biology Society
Sponsored by the
IEEE 11073™ Standards Committee
IEEE
IEEE Std 11073-30200a™-2011
3 Park Avenue
(Amendment to
New York, NY 10016-5997
USA ISO/IEEE 11073-30200:2004)
16 September 2011
TM
IEEE Std 11073-30200a -2011
(Amendment to
ISO/IEEE Std 11073-30200:2004)
Health informatics—Point-of-care medical device communication
Part 30200: Transport profile—
Cable connected
Amendment 1
Sponsor
TM
IEEE 11073 Standards Committee
of the
IEEE Engineering in Medicine and Biology Society
Approved 16 June 2011
IEEE-SA Standards Board
Abstract: ISO/IEEE Std 11073-30200:2004 is extended in this amendment to include
IEEE 802.3 100BASE-T and analysis of the compatibility of cable connections between ISO/IEEE
TM
Std 11073-30200:2004 and IEEE Std 802.3 -2008.
Keywords: bedside, IEEE 11073, IEEE Std 802.3-2008, Infrared Data Association (IrDA), legacy
device, medical device, medical device communications, MIB, patient, SNTP
•
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Introduction
This introduction is not part of IEEE Std 11073-30200a-2011, Health informatics—Point-of-care medical device
communication—Part 30200: Transport profile—Cable connected—Amendment 1.
This amendment extends ISO/IEEE Std 11073-30200:2004 to include IEEE 802.3 100BASE-T, and it
includes analysis of the compatibility of cable connections between ISO/IEEE Std 11073-30200:2004 and
a
IEEE Std 802.3-2008 [B10].
Notice to users
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a
The numbers in brackets correspond to those of the bibliography in Annex P.
iv
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v
Participants
At the time this standard was submitted to the IEEE-SA Standards Board for approval, the InterLAN
Working Group had the following membership:
Malcolm Clarke, Chair
Mark Schnell, Vice Chair
Chuck Baker Nicolae Goga Paul Schluter
Douglas P. Bogia Kai Hassing Rick Schrenker
Jon Camp Stuart Higgins Seith Seidman
Thomas Canup Nandu Kushalnagar Mazen Shihabi
Randy Carroll Mike Miller Lars Steubesand
Tony Chan Melvin Reynolds Stan Wiley
Todd Cooper Shekar Roa Jan Wittenber
Mark Craig Jr. Judi Romijn Tetsuya Yuda
Juergen Fischbach Honggang Zhang

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

Hugh Barrass Atsushi Ito Bartien Sayogo
Christopher Biernacki Raj Jain Gil Shultz
Keith Chow Piotr Karocki James Smith
Malcolm Clarke Randall Krohn Lars Steubesand
Randall Groves William Lumpkins Walter Struppler
Kai Hassing Greg Luri Jan Wittenber
Werner Hoelzl Wayne W. Manges Oren Yuen
Melvin Reynolds
When the IEEE-SA Standards Board approved this standard on 16 June 2011, it had the following
membership:
Richard H. Hulett, Chair
John Kulick, Vice Chair
Robert Grow, Past Chair
Judith Gorman, Secretary
Masayuki Ariyoshi Jim Hughes Gary Robinson
William Bartley Joseph L. Koepfinger* Jon Rosdahl
Ted Burse David Law Sam Sciacca
Clint Chaplin Thomas Lee Mike Seavey
Wael Diab Hung Ling Curtis Siller
Jean-Philippe Faure Oleg Logvinov Phil Winston
Alex Gelman Ted Olsen Howard Wolfman
Paul Houzé Don Wright
*Member Emeritus
vi
Also included are the following nonvoting IEEE-SA Standards Board liaisons:
Satish Aggarwal, NRC Representative
Richard DeBlasio, DOE Representative
Michael Janezic, NIST Representative

Don Messina
IEEE Standards Program Manager, Document Development

Kathryn M. Bennett
IEEE Standards Program Manager, Technical Program Development

vii
Contents
1. Overview . 2
3.1 Definitions . 3
3.2 Acronyms and abbreviations . 5
4. Goals for this standard . 5
4.1 Compliance with other standards . 5
6. Physical layer . 5
Annex A (normative) Phyiscal layer . 6
Annex E (informative) Detailed rationale for pin assignments . 8
Annex F (informative) IEEE Std 802.3-2008 10BASE-T/100BASE-TX . 9
Annex O (informative) Analysis of compatibility between ISO/IEEE Std 11073-30200:2004 and 10BASE-
T/100BASE-TX of IEEE Std 802.3-2008 . 10
Annex OP (informative) Bibliography . 36

viii
ISO/IEEE 11073-30200:2004/Amd 1:2015(E)
Health informatics—Point-of-care medical device communication
Part 30200: Transport profile—
Cable connected
Amendment 1
IMPORTANT NOTICE: This standard is not intended to ensure safety, security, health, or
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NOTE—The editing instructions contained in this corrigendum define how to merge the material contained therein into
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Notes in text, tables, and figures are given for information only and do not contain requirements needed to implement the standard.
ISO/IEEE 11073-30200:2004/Amd 1:2015(E)
IEEE Std 11073-30200a-2011
Health informatics—Point-of-care medical device communication
Part 30200: Transport profile—Cable connected—Amendment 1
1. Overview
Change text as shown:
This standard is divided into 11 clauses, as follows:
⎯ Clause 1 provides an overview of this standard.
⎯ Clause 2 lists references to other standards that are useful in applying this standard.
⎯ Clause 3 provides definitions and abbreviations.
⎯ Clause 4 provides goals for this standard.
⎯ Clause 5 provides an overview of network topology and layering.
⎯ Clause 6 provides a profile of the physical layer.
⎯ Clause 7 provides a profile of the data link layer.
⎯ Clause 8 provides a profile of the network layer.
⎯ Clause 9 provides a profile of the transport layer.
⎯ Clause 10 describes the optional time synchronization service.
⎯ Clause 11 provides labeling and conformance requirements.
This standard also contains 1516 annexes, as follows:
⎯ Annex A describes the physical layer.
⎯ Annex B provides information on the maximum cable length.
⎯ Annex C provides examples of physical link media.
⎯ Annex D provides example schematics for modular adapters.
⎯ Annex E provides a detailed rationale for pin assignments.
⎯ Annex F describes the use of IEEE 802.3 10BASE-T/100BASE-TX with this standard.
⎯ Annex G provides a discussion of power delivery considerations.
⎯ Annex H provides examples of simple bedside communications controller (BCC) and device
communications controller (DCC) designs.
⎯ Annex I provides an example of an isolated BCC design.
⎯ Annex J provides an optical isolator design example.
⎯ Annex K provides marking guidelines.
⎯ Annex L provides protocol examples, particularly of connection establishment.
⎯ Annex M defines the Infrared Data Association (IrDA) profile specifications adapted from the
IrDA implementation guidelines.
⎯ Annex N provides guidelines for using the SNTP time synchronization protocol.
⎯ Annex O provides an analysis of compatibility between ISO/IEEE Std 11073-30200:2004 and
10BASE-T/100BASE-TX of IEEE Std 802.3-2008 [B10].
⎯ Annex OP provides bibliographical references.
ISO/IEEE 11073-30200:2004/Amd 1:2015(E)
IEEE Std 11073-30200a-2011
Health informatics—Point-of-care medical device communication
Part 30200: Transport profile—Cable connected—Amendment 1
3. Definitions, acronyms, and abbreviations
3.1 Definitions
Change the first paragraph and insert new footnote as shown. Delete [B2] from Annex O and renumber
subsequent references in Annex O:
For the purposes of this document, the following terms and definitions apply. The Authoritative Dictionary
of IEEE Standards Terms, Seventh Edition, [B2]The IEEE Standards Dictionary: Glossary of Terms &
Definitions should be consulted for terms not defined in this clause.
Note that numerous definitions and abbreviations from IEEE Std 802.3–2008 [B10] are used in this
document. Those definitions and abbreviations will not be repeated here. For specific information, please
refer to Section One, subclause 1.4 and subclause 1.5, of IEEE Std 802.3-2008.
Change existing definitions and insert new definitions as shown:
3.1.1 10BASE-T: IEEE Std 802.3-2008 1998 Edition,physical layer specification for Ethernet over two
pairs of unshielded twisted-pair (UTP) media at 10 Mb/s.
100BASE-TX: IEEE Std 802.3-2008 specifies operation over two copper media: two pairs of shielded
twisted-pair cable (STP) and two pairs of unshielded twisted-pair cable (Category 5 UTP). For the purposes
of this standard, only UTP is permitted.
3.1.2 baud: A unit of signaling speed, expressed as the number of times per second the signal can change
the electrical state of the transmission line or other medium.
NOTE—Depending on the encoding strategies, a signal event may represent a single bit, more, or less, than one bit.
3.1.3 bedside communications controller (BCC): A communications controller, 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.
3.1.4 beginning of frame (BOF): An octet specified by infrared link access protocol (IrLAP).
3.1.5 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)
3.1.6 cyclic redundancy check (CRC): The result of a calculation carried out on the octets within an
IrLAP frame; also called a frame check sequence. The CRC is appended to the transmitted frame. At the
receiver, the calculation creating the CRC may be repeated, and the result compared to that encoded in the
signal. Syn: frame check sequence.
3.1.7 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 BCC.
The IEEE Standards Dictionary: Glossary of Terms & Definitions is available at http://standards.ieee.org.
ISO/IEEE 11073-30200:2004/Amd 1:2015(E)
IEEE Std 11073-30200a-2011
Health informatics—Point-of-care medical device communication
Part 30200: Transport profile—Cable connected—Amendment 1

3.1.8 electromagnetic compatibility (EMC): The ability of a device, equipment, or system to function
satisfactorily in its electromagnetic environment without introducing intolerable electromagnetic
disturbances to anything in that environment.
3.1.9 electromagnetic interference (EMI): Signals emanating from external sources (e.g., power supplies,
transmitters) or internal sources (e.g., adjacent electronic components, energy sources) that disrupt or
prevent operation of electronic systems.
3.1.10 electrostatic discharge (ESD): The sudden transfer of charge between bodies of differing
electrostatic potentials that may produce voltages or currents that could destroy or damage electrical
components.
3.1.11 frame check sequence: See: cyclic redundancy check.
3.1.12 high-level data link control (HDLC): A standard protocol defined by ISO for bit-oriented, frame
delimited data communications.
3.1.13 information access service (IAS): A component of infrared link management protocol (IrLMP).
3.1.14 local area network (LAN): A communication network to interconnect a variety of intelligent
devices (e.g., personal computers, workstations, printers, file storage devices) that can transmit data over a
limited area, typically within a facility.
3.1.15 medical information bus (MIB): The informal name for the ISO/IEEE 11073 family of standards.
3.1.16 octet: A group of eight adjacent bits.
3.1.17 primary station: As defined by the infrared link access protocol (IrLAP), the station on the data
link that assumes responsibility for the organization of data flow and for unrecoverable data link error
conditions. It issues commands to the secondary stations and gives them permission to transmit.
3.1.18 protocol data unit (PDU): Information delivered as a unit between peer entities that contains
control information and, optionally, data.
3.1.19 quality of service (QoS): The four negotiated parameters for a link: signaling speed, maximum
turnaround time, data size, and disconnect threshold.
3.1.20 radio frequency (RF): (A) (Loosely) The frequency in the portion of the electromagnetic spectrum
that is between the audio-frequency portion and the infrared portion. (B) A frequency useful for radio
transmission.
3.1.21 radio frequency interference (RFI): See: radio interference.
3.1.22 radio interference: Degradation of the reception of a wanted signal caused by radio frequency (RF)
disturbance.
3.1.23 RJ-45: (A) AT&T Registered Jack designation for the eight-pin modular connectors that meet the
requirements of IEC 60603-7:1996 and ISO/IEC 8877:1992. (B) An eight-pin modular telephone plug.
3.1.24 RS-232: The serial interface defined in ANSI/TIA/EIA-232-F-1997.
3.1.25 secondary station: As defined by the infrared link access protocol (IrLAP), any station on the data
link that does not assume the role of the primary station. It will initiate transmission only as a result of
receiving explicit permission to do so from the primary station.
3.1.26 service access point (SAP): An address that identifies a user of the services of a protocol entity.
ISO/IEEE 11073-30200:2004/Amd 1:2015(E)
IEEE Std 11073-30200a-2011
Health informatics—Point-of-care medical device communication
Part 30200: Transport profile—Cable connected—Amendment 1

3.1.27 service data unit (SDU): Information that is delivered as a unit between peer service access points
(SAPs). See: service access point.
3.1.28 set normal response mode (SNRM): A high-level data link control (HDLC) message sent by a
bedside communications controller (BCC) to a device communications controller (DCC) when a successful
connection to the network has occurred.
3.2 Acronyms and abbreviations
Insert the following new abbreviation in alphabetical order as shown:
NTP network time protocol
PoC point of care
PLL phase-locked loop
4. Goals for this standard
Insert the following new subclause as shown:
4.1 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 [B10] 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 60601-1:2005 [B6] base standards and its parts, such as IEC 60601-1-1:2000 [B7], with respect to
electrical and mechanical safety and any device specific standard as might be defined in
IEC 60601-1-2:2007 [B8]. Software aspects may apply through standards such as EN 62304:2005 [B5].
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 [B11] and IEC 80001-1:2010 [B9]. The requirements of such risk
assessment and risk management and conformance are outside the scope of this standard.
6. Physical layer
Insert the following text to the dashed list as shown:

—Annex F describes the use of 10BASE-T/100BASE-TX with this standard.

ISO/IEEE 11073-30200:2004/Amd 1:2015(E)
IEEE Std 11073-30200a-2011
Health informatics—Point-of-care medical device communication
Part 30200: Transport profile—Cable connected—Amendment 1

Annex A
(normative)
Physical layer
A.1 Overview
Change the following text as shown:
A.1.4 10BASE-T/100BASE-TX
This standard provides a measure of compatibility with high-speed communication using 10BASE-T and
100BASE-TX as defined in Section One and Section Two, respectively, of
IEEE Std 802.3-2008 [B10]Clause 14 of IEEE Std 802.3, 1998 Edition.
A.4 Connector pin assignments and functions
A.4.3 Signal names and functions
Replace Table A.4 with the following table:
Table A.4—Signal names and functions
BCC connector DCC connector Function
bBPWR dBPWR Power from BCC
N/A dDPWR Power from DCC and sense BCC connection (+)
bGND dGND Signal ground
bRxD dRxD RS-232 data receive
bTxD dTxD RS-232 data transmit
bCS+ N/A Sense DCC connection (+)
bCS– dCS– Connection sense (–)
bRD+ dRD+ 10BASE-T/100BASE-TX receive data (+)
bRD– dRD– 10BASE-T/100BASE-TX receive data (–)
bTD+ dTD+ 10BASE-T/100BASE-TX transmit data (+)
bTD– dTD– 10BASE-T/100BASE-TX transmit data (–)

Change the third and fourth paragraphs as shown:
This standard is compatible with a 10BASE-T/100BASE-TX interface, supported by the RD± and TD±
signals (pins 1-2 and 3-6). A BCC port may be designed to support the ability to detect an
ISO/IEEE 11073-30200 (RS-232) connection or a 10BASE-T/100BASE-TX connection and to
communicate with either device. However, all 10BASE-T/100BASE-TX functions for BCCs and DCCs are
ISO/IEEE 11073-30200:2004/Amd 1:2015(E)
IEEE Std 11073-30200a-2011
Health informatics—Point-of-care medical device communication
Part 30200: Transport profile—Cable connected—Amendment 1

out of the scope of this standard. Refer to Annex F for more information on the 10BASE-T/100BASE-TX
interface.
A BCC can sense the connection of a DCC by testing the resistance across its bCS+ and bCS– pins. The
alternative names bTD+ and bTD– indicate the 10BASE-T/100BASE-TX transmit data function.
A DCC may provide power on its dDPWR line to a line-extender or communications adapter. A DCC can
sense its connection to a BCC by testing the resistance between its dDPWR and dCS– pins. The alternative
names dTD+ and dTD– indicate the 10BASE-T transmit data function.
A.4.4 BCC pin assignments and functions
Change the third paragraph as shown:
The bRD± pins of the BCC shall be shorted together or terminated with R < 110 (R = 100 preferred) to
allow a DCC to detect its connection to the BCC. A BCC port with 10BASE-T/100BASE-TX capability
automatically satisfies this requirement due to the low dc resistance (< 0.5 ) of the bRD± input transformer
windings.
A.4.5 DCC pin assignments and functions
Change the third and fourth paragraphs as shown:
The dRD± pins of the DCC shall be shorted together or terminated with R < 110 Ω (R = 100 Ω preferred) to
allow a BCC to detect its connection to the DCC. The short or termination shall not be electrically
connected to any other internal DCC circuitry (i.e., there is no dc path to ground). A DCC with 10BASE-
T/100BASE-TX capability automatically satisfies this requirement due to the low dc resistance (< 0.5 Ω) of
the dRD± input transformer windings.
A DCC may provide circuitry to sense its connection to a BCC by testing the dc resistance between its
dDPWR and dCS– pins. For a DCC that provides power on its dDPWR pin, the connection sense circuit
should tolerate or detect the reduced voltage on the dDPWR line due to a line extender or adapter that uses
more current than dDPWR can provide. Alternatively, a DCC that provides the zero-power option (and
does not have 10BASE-T/100BASE-TX capability) may tie dDPWR to dGND and apply a test current to
its dCS– pin.
SIST EN ISO 11073-30200:2005/A1:20
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