1、Health informatics Interoperability of patient connected medical devices ICs 35.240.80 DD ENV 13735:200 i DD ENV 13735:20001 Amd. No. National foreword Date Comments This Draft for Development is the English language version of ENV 13735:2001. This publication is not to be regarded as a British Stan
2、dard. It is being issued in the Draft for Development series of publications and is of a provisional nature due to the limited duration ofthe European Prestandard. It should be applied on this provisional basis, so that information and experience of its practical application may be obtained. Comment
3、s arising from the use ifthis Draft for Development are requested so that UK experience can be reported to the European organization responsible for its conversion into a European Standard. A review of this publication will be initiated 2 years after its publication by the European organization so t
4、hat a decision can be taken on its status at the end of its three-year life. The commencement of the review period will be notified by an announcement in Update Standards. According to the replies received by the end of the review period, the responsible BSI Committee will decide whether to support
5、the conversion into a European Standard, to extend the life of the prestandard or to withdraw it. Comments should be sent in writing to the Secretary ofBSI Technical Committee IST/35, Health Informatics, at 389 Chiswick High Road, London W4 4AL, giving the document reference and clause number and pr
6、oposing, where possible, an appropriate revision of the text. A list of organizations represented on this committee can be obtained on request to its secretary. Cr oss-r e fer enc e s The British Standards which implement international or European publications referred to in this document may be fou
7、nd in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue. This Draft for Develovment. having been prepared under the directionoftheDISCboard, Summary Of pages was vublished u
8、nder the This document comprises a front cover, an inside front cover, the ENV title autiority of the Standards on 19 October 2001 page, pages 2 to 175 and a back cover. The BSI copyright date displayed in this document indicates when the Policy and Strategy Committee document was last issued. O BSI
9、 19 October 2001 ISBN O 580 38594 9 EU ROPEAN PRESTAN DARD PRENORME EUROPENNE EUROPISCHE VORNORM ENV 13735 September 2000 ICs 35.240.80 English version Health informatics - Interoperability of patient connected medical devi ces This European Prestandard (ENV) was approved by CEN on 7 January 2000 as
10、 a prospective standard for provisional application The period of validity of this ENV is limited initially to three years. After two years the members of CEN will be requested to submit their comments, particularly on the question whether the ENV can be converted into a European Standard. CEN membe
11、rs are required to announce the existence of this ENV in the same way as for an EN and to make the ENV available promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in parallel to the ENV) until the final decision about the possible c
12、onversion of the ENV into an EN is reached. CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMIT
13、TEE FOR STANDARDIZATION EUROPISCHES KOMITEE FUR NORMUNG COMIT EUROPEN DE NORMALISATION Central Secretariat: rue de Stassart, 36 B-1050 Brussels O 2000 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. ENV 13735:2000 E Page 2 ENV 13735:2
14、000 Contents Foreword . 4 Introduction 5 1 2 3 4 5 6 6.1 6.2 6.3 7 7.1 7.2 7.3 7.4 7.5 7.6 8 8.1 8.2 8.3 8.4 9 9.1 9.2 9.3 9.4 Scope . 6 Normative reference(s) 6 Term(s) and definition(s) . 6 Symbols (and abbreviated terms) 11 Requirements . 13 Models . 14 Domain Information Model for the Communicat
15、ion Subject . 14 Object Definitions . 16 Dynamic Model . 24 Messages 30 General . 30 ACSE Protocol 31 Session Layer Protocol . 31 Presentation Layer Protocol . 31 ROSE Protocol 32 CMDISE Protocol (CMDIP) . 32 Encoding rules . 33 Overview . 33 Medical Data Encoding Rules (MDER) . 34 Abstract Syntax 3
16、4 Transfer Syntax 34 Application Profiles 35 General 35 Baseline Application Profile 36 Polling Mode Application Profile 53 Conformance 61 Page 3 ENV 13735:2000 9.5 Annex A (informative) Example Optional Packages . 67 Annex B (normative) Nomenclature Extensions . 70 Annex C (informative) ACSE User I
17、nfo Field . 78 Implementation Conformance Statements 61 Annex D (normative) IEEE 1073 Specific MIB Element Object Definitions 80 Annex E (informative) Requirements and Scenarios 84 Annex F (Informative) Mapping between Scenarios. Device Types and Application Profiles . 101 Annex G (normative) State
18、Transition Tables . 171 Page 4 ENV 13735:2000 Foreword This European Prestandard has been prepared by Technical Committee CEN/TC 251 “Health informatics“, the secretariat of which is held by SIS. According to the CENKENELEC Internal Regulations, the national standards organizations of the following
19、countries are bound to announce this European Prestandard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Page 5 ENV 13735:2000 A C S E Introduction Tr
20、ansport System Medical technology has developed in the context of rapid advances in the science of information technology and has benefited greatly by incorporating these advances into many medical devices. This has been done in a relatively unstructured manner with many devices being developed in i
21、solation and in a way that precludes communication both between themselves and with hospital computer and data management systems. Those devices that can communicate generally use a proprietary communication protocol, which precludes connection to devices from different manufacturers. Transport Syst
22、em The potential advantages of such communication are becoming more and more obvious. Consequently, there is a pressing need for technical standardisation and the development of services and protocols to enable such communication to exist in an easy and open way, with subsequent clinical. administra
23、tive and research benefits. The first steps toward the development of such a standard were initiated by IEEE group p1073 in 1984 developing what has become know as the Medical Information Bus (MIB). The development of that set of standards has followed the ISO/OSI layers as demonstrated in the follo
24、wing figure: Manager Application Process(es) CMDISE I A C S E r I CMDISE I I Figure 1 - . Example of agent manager communication system following ISOIOSI principals. An essential element was the development of a standard for Vital Signs Information Representation, which covered the objects and attri
25、butes collectively known as the MDIB (area shaded in fig 1). This work has now been done ( ENV 13734). The next stage, which is the focus of this project, is the development of necessary services and protocols, based on ISO/OSI standards, which enable true interoperability between medical devices. T
26、hese cover the areas in the figure marked as ACSE, CMDISE, presentation layer and session layer. Interoperability of medical devices raises many technical, safety, and legal issues, which are worthy of consideration. The ongoing work of the IEEE standards group IEEE 1073 has been taken into consider
27、ation and reference is made particularly to their proposed standard 1073.2.0 Medical Device Application Profile (MDAP). Page 6 ENV 13735:2000 The primary user of this standard is a software engineer who is developing interface software for medical devices covered in the scope. This is one of a numbe
28、r of standards that the engineer should be familiar with, including the following: IS0 open systems interconnection (0.9) layered architecture. IEEE 1073.1 MIB framework and overview. CEN ENV 13734 “Vital Signs Information Representation” 1 Scope This European standard applies to patient connected m
29、edical devices that can communicate patient related physiological data between devices and between a device and a computer system. Examples of applicable devices are given in annex E. This standard specifies a communication controller model that should be used by applicable devices. This standard st
30、ates applicable references or specifies protocols including the ACSE, ROSE, CMDISE, presentation and session layer protocols that shall be used by applicable devices. This standard defines application profiles that shall be used by applicable devices, and that shall be quoted by manufacturers when c
31、laiming conformance to this standard. Appropriate conformance statement templates are provided. 2 Normative reference(s) The following normative documents contain provisions that, through reference in this text, constitute provisions of this CEN Standard. For dated references, subsequent amendments
32、to, or revisions of, any of these publications do not apply. However, parties to agreements based on this CEN Standard are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For an undated reference, the latest edition of the no
33、rmative document referred to will apply. IEEE 1073.2.0: Standard for Medical Device Communications - Medical Device Application Profile IEEE 1073.3.1: 1996 Standard for Medical Device Communications - Transport Profile - Connection Mode IEEE 1073.4.1: 1996 Standard for Medical Device Communications
34、- Physical Layer Interface - Cable-connected ENV 13734: 1999 Vital Signs Information Representation (VITAL ) IS0 7498-1 : 1994 Information Technology - Open Systems Interconnection - Basic Reference Model IS0 8649: Information technology - Open Systems Interconnection - Service definition for the As
35、sociation Control Service Element IS0 8824: 1990 Information technology - Open Systems Interconnection - Specification of Abstract Syntax Notation One (ASN.l). IS0 8825 Information technology - Open Systems Interconnection - Specification of encoding rules for Abstract Syntax Notation One (ASN.l). I
36、S0 9596 Information technology - Open Systems Interconnection - Common Management Information Protocol Specification 3 Term(s) and definition(s) 3.1 Agent: A Medical Device which provides data in a managedagent communicating system. 3.2 Alarm: A Signal which indicates abnormal events occurring to th
37、e patient or the device system. Page 7 ENV 13735:2000 3.3 Alert: Synonym for the combination of patient-related physiological alarms, technical alarms and equipment user advisory signals. 3.4 Alert Monitor: Object representing the output of a device or system alarm processor and as such the overall
38、device or system alarm condition. 3.5 Alert Status: Object representing the output of an alarm process that considers all alarm conditions in a scope that spans one or more objects. 3.6 Archival: Relating to the storage of data over a prolonged period. 3.7 Association Control Service Element Method
39、used to establish logical connections between medical device systems 3.8 Channel: Umbrella object in the object model that groups together physiological measurement data and data derived from these data. 3.9 Class: Description of one or more objects with a uniform set of attributes and services incl
40、uding a description of how to create new objects in the class. 3.10 Common Medical Device Information Service Element With associated protocol provides services that allow access to the object instances in the Medical Data Information Base. 3.1 1 Communication Controller: Part of a Medical Device Sy
41、stem responsible for communications 3.12 Communication Party: Actor of the problem domain participating in the communication therein 3.13 Communication Role: Role of a party in a communication situation defining the partys behaviour in the communication. Associated with a communication role is a set
42、 of services which the party provides to other parties. 3.14 Data Format: Arrangement of data in a file or stream. 3.15 Data Logger: A medical device which is functioning in its capacity as a data storage and archival system. Page 8 ENV 13735:2000 3.16 Data Agent: As a medical device a patient data
43、acquisition system which provides the acquired data for other devices. 3.17 Data Structure: Manner in which application entities construct the data set information resulting from the use of an information object. 3.18 Dictionary: Description of the contents of the Medical Data Information Base conta
44、ining vital signs information, device information, demographics, and other elements of the MDIB. 3.19 Discrete Parameter: Vital signs measurement that can be expressed as a single numeric or textual value. 3.20 Domain Information Model: The model describing common concepts and relationships for a pr
45、oblem domain. 3.21 Event: A noteworthy occurrence that has a location in time and space. 3.22 Event Rep0 rt : Service (provided by the CMDISE) to report data relating to a managed object instance. 3.23 Framework: A structure of processes and specifications designed to support the accomplishment of a
46、 specific task. 3.24 Graphic Parameter: Vital signs measurement that requires a number of regularly sampled data points in order to be expressed properly. 3.25 Host system: Term used as an abstraction of a medical system to which measurement devices are attached. 3.26 Information Objects: Provide an
47、 abstract data model applicable to the communication of vital signs information and related patient data. The attributes of an information object definition describe its properties. Each information object definition does not represent a specific instance of real-world data, but rather a class of da
48、ta which share the same properties. 3.27 Instance: For example: object instance, application instance, information service element instance, VMD instance, class instance, operating instance 3.28 Intensive Care Unit: Unit within a hospital in which critically ill patients are managed using multiple m
49、odes of monitoring and vital system supports. Page 9 ENV 13735:2000 3.29 Interchange Format: The representation of the data elements and the structure of the message containing those data elements while in transfer between systems. The interchange format consists of a data set of construction elements and a syntax. The representation is technology specific. 3.30 Interoperability: Idealised scheme whereby medical devices of differing types, models or manufacturers, are capable of working with each other, whether connected to each other directly or through a communication system. The com
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