1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationHealth informatics Point-of-care medical device communicationPart 30400: Interface profile Cabled Ethernet (ISO 11073-30400:2012)BS EN ISO 11073-30400:2012National forewordThis B
2、ritish Standard is the UK implementation of EN ISO 11073-30400:2012.The UK participation in its preparation was entrusted to Technical CommitteeIST/35, Health informatics.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purpor
3、t to include all the necessary provisions of acontract. Users are responsible for its correct application. The British Standards Institution 2012Published by BSI Standards Limited 2012ISBN 978 0 580 79087 4ICS 35.240.80Compliance with a British Standard cannot confer immunity fromlegal obligations.T
4、his British Standard was published under the authority of the StandardsPolicy and Strategy Committee on 30 November 2012.Amendments issued since publicationAmd. No. Date Text affectedBRITISH STANDARDBS EN ISO 11073-30400:2012EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11073-30400 Novemb
5、er 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 sant - Communication entre dispositifs mdicaux sur le site des soins - Partie 30400: Profil dinterface - Ethe
6、rnet cbl (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-da
7、te 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
8、 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, For
9、mer 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 COMIT
10、 EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR 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: EBS EN ISO 11073-30400:2012EN ISO 11073-30400:
11、2012 (E) 2 Contents Page Foreword 3BS EN ISO 11073-30400:2012EN ISO 11073-30400:2012 (E) 3 Foreword This document (EN ISO 11073-30400:2012) has been prepared by Technical Committee ISO/TC 215 “Health informatics“ in collaboration with Technical Committee CEN/TC 251 “Health informatics” the secretari
12、at of which is held by NEN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by May 2013, and conflicting national standards shall be withdrawn at the latest by May 2013. Attention is drawn to the pos
13、sibility 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 organisations of the following countries
14、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,
15、Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 11073-30400:2012 has been approved by CEN as a EN ISO 11073-30400:2012 without any modification. BS EN ISO 11073-30400:2012ISO/IEEE 11073-30400:2012(E) ISO 2012 All ri
16、ghts reserved IEEE 2012 All rights reserved iiiContents 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 di
17、agram 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
18、group definition 10 6.1 Section-level summary 10 6.2 Clause/annex level mapping 10 Annex A (informative) Bibliography . 30 Annex B (informative) IEEE list of participants 31 BS EN ISO 11073-30400:2012ISO/IEEE 11073-30400:2012(E) vi ISO 2012 All rights reserved IEEE 2012 All rights reservedIntroducti
19、on This introduction is not part of IEEE Std 11073-30400-2010, Health informaticsPoint-of-Care medical device communicationPart 30400: Interface profileCabled Ethernet. ISO/IEEE 11073 standards enable communication between medical devices and external computer systems. They provide automatic and det
20、ailed 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, acqui
21、red 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 automat
22、ically 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 app
23、lications 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
24、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.
25、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,athat are appropriate for the medical communications environment. This standard
26、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 p
27、ersonnel 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. aInformation on references can be found in Clause 2. BS EN ISO 11073
28、-30400:2012IMPORTANT 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
29、 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 obtai
30、ned 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
31、 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 1
32、1073 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. 1Information on references ca
33、n be found in Clause 2. ISO/IEEE 11073-30400:2012(E) ISO 2012 All rights reserved IEEE 2012 All rights reserved 1Part 30400: Interface profile Cabled Ethernet Health informatics Point-of-care medical devicecommunication BS EN ISO 11073-30400:20122 Normative references The following referenced docume
34、nts 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 th
35、e referenced document (including any amendments or corrigenda) applies. ANSI/TIA/EIA 568-A-1995, Commercial Building Telecommunications Cabling Standard.2IEEE Std 802.3TM-2008, Standard for Information technologyTelecommunications and Information Exchange Between SystemsLocal and Metropolitan Area N
36、etworksSpecific Requirements Part 3: Carrier Sense Multiple Access with Collision Detection (CSMA/CD) Access Method and Physical Layer Specifications.3,4ISO/IEEE 11073-30200:2004, Health InformaticsPoint-of-Care Medical Device CommunicationPart 30200: Transport ProfileCable Connected.53 Definitions,
37、 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 no repeater functionality is supported in IEEE Std 11073-30400-2010. Thus, the multisegment considerations of this clause are no
38、t applicable. Performance feature group applicability: Yes. Rationale: The Performance feature group does support the 1000BASE-T interface. However, IEEE Std 11073-30400-2010 does not support any repeater functionality. Thus, the multisegment considerations of this clause are not applicable. No No N
39、o Link Aggregation 43 Rationale: The link aggregation features of IEEE Std 802.3-2008 are not used in IEEE Std 11073-30400-2010. Thus, this clause is not applicable. No No No ISO 2012 All rights reserved IEEE 2012 All rights reservedISO/IEEE 11073-30400:2012(E)22BS EN ISO 11073-30400:2012Table 5Mapp
40、ing for IEEE Std 802.3-2008: Section Three: Ethernet 1000 Mb/s interface (continued) Applicability to IEEE 11073-30400 Clause/| annex Clause title / applicability rationale Legacy group: No (0 of 19) Standard group: No (0 of 19) Performance group: Partial (8 of 19) (informative) Jitter test pattern.
41、 Annex 36A Rationale: The IEEE 802.3 1000 Mb/s fiber optic physical layer options are not used in IEEE Std 11073-30400-2010. Thus, this annex is not applicable. No No No (informative) 8B/10B transmission code running disparity calculation examples Annex 36B Rationale: The IEEE 802.3 1000 Mb/s fiber
42、optic physical layer options are not used in IEEE Std 11073-30400-2010. Thus, this annex is not applicable. No No No (informative) Fiber launch conditions Annex 38A Rationale: The IEEE 802.3 1000 Mb/s fiber optic physical layer options are not used in IEEE Std 11073-30400-2010. Thus, this annex is n
43、ot applicable. No No No (informative) Additional cabling design guidelines Annex 40A Legacy and Standard feature group applicability: No. Rationale: The Legacy and Standard feature groups do not support the 1000BASE-T interface. Thus, this annex is not applicable. Performance feature group applicabi
44、lity: Yes. Rationale: The Performance feature group does support the 1000BASE-T interface. Thus, the contents of this annex are applicable to the use of the twisted pair 1000BASE-T physical layer option used in IEEE Std 11073-30400-2010. No No Yes (informative) Description of cable clamp Annex 40B L
45、egacy and Standard feature group applicability: No. Rationale: The Legacy and Standard feature groups do not support the 1000BASE-T interface. Thus, this annex is not applicable. Performance feature group applicability: Yes. Rationale: The Performance feature group does support the 1000BASE-T interf
46、ace. Thus, the contents of this annex are applicable to the use of the twisted pair 1000BASE-T physical layer option used in IEEE Std 11073-30400-2010. No No Yes (informative) Add-on interface for additional Next Pages Annex 40C Legacy and Standard feature group applicability: No. Rationale: The Leg
47、acy and Standard feature groups do not support the 1000BASE-T interface. Thus, this annex is not applicable. Performance feature group applicability: Yes. Rationale: The Performance feature group does support the 1000BASE-T interface. Thus, the contents of this annex are applicable to the use of the twisted pair 1000BASE-T physical layer option used in IEEE Std 11073-30400-2010. No No Yes ISO 2012 All rights reserved IEEE 2012 All rights reserved ISO/IEEE 11073-30400:2012(E)23BS EN ISO 11073-30400:2012
