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BS ISO 11073-90101:2008

Current

Current

The latest, up-to-date edition.

Health informatics. Point-of-care medical device communication Analytical instruments. Point-of-care test

Published date

29-02-2008

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Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Definitions
4 Specifications
  4.1 Description of Connectivity System Components
  4.2 The Interfaces
References
Appendix A - Device and Access Point (DAP) Interface
             Specification
1 Scope and Introduction
2 Definitions
3 Abbreviations
4 Overview of POC Device Networking (Informative)
5 Overview of IrDA and ISO/IEEE 11073-30200
   (Informative)
6 Requirements for a 'POCT1-compatible' Device
   (Normative)
7 Requirements for a 'POCT1-compatible' Access Point
   (Normative)
8 Networked Access Points (Normative if Implemented)
9 Remote Modem Access (Informative)
10 POC Devices With Direct Network Connections
   (Informative)
11 Data Security (Informative)
12 RF Wireless Networking Technologies (Informative)
13 References
Appendix B - Device Messaging Layer (DML) Specification
1 Scope and Introduction
2 Bidirectional Communication
3 General Messaging Issues
4 Messaging Profile
5 Information Model
6 Messaging Model
7 Extending the Device Messaging Layer
8 Annex A. Device Messaging Layer Data Types (Normative)
9 Annex B. Asynchronous Observation Acknowledgements
   (Normative)
10 Annex C. 'SET-TIME' Time Stamp and Time Zone Information
11 Annex D. Example Messages (Informative)
12 Annex E. POCT1 Messaging DTDs (Normative)
Appendix C - Observation Reporting Interface (ORI)
             Specification
1 Scope and Introduction
2 Use Case Descriptions
3 Message Profile
4 HL7 Message Definition
5 Sample Messages
Appendix D - Point-of-Care Requirements
1 Requirements
Appendix E - Connectivity Architecture
1 Architecture
2 Principles
3 Approach
4 Model
Appendix F - Vendor Codes
1 Vendor Codes
Summary of Comments and Subcommittee Responses
The Quality System Approach
Related CLSI/NCCLS Publications

Covers a set of specifications to allow seamless multivendor interoperability and communication between point-of-care devices, data concentrators, and clinical information systems.

Committee
IST/35
DevelopmentNote
Supersedes 06/30084270 DC. (02/2008)
DocumentType
Standard
PublisherName
British Standards Institution
Status
Current
Supersedes

This standard establishes a set of specifications to allow seamless multivendor interoperability and communication between point-of-care devices, data concentrators, and clinical information systems. CLSI document POCT1 provides the framework for engineers to design devices, workstations, and interfaces that allow multiple types and brands of point-of-care devices to communicate bidirectionally with access points, data concentrators, and laboratory information systems from a variety of vendors.

As an interface standard, this document specifies the common communication interfaces and protocols between systems and devices. It facilitates the transfer of data to support the creation of point-of-care applications, services, and institutional policies. This document does not directly address specific point-of-care application and service level functions, such as device lockout and operator list management. This document specifies protocol, not policy. The interfaces specified support the communication required for engineers to build such application-level functionality. Specifying, building, and providing the applications to support these services are left to customers, device and information system vendors.

The only relationship of this point-of-care standard to the laboratory automation domain is through the use of the HL7 standard. In version 2.4,1 the HL7 standard was expanded to provide elements essential to laboratory automation, which also improved the HL7 standard for the entire laboratory-testing domain. These additions to HL7, along with four proposed new HL7 message triggers (see Section4.1 in Appendix C of this CLSI standard), enable the point-of-care community to use HL7as its electronic data interchange (EDI).

This specification also leverages several communication standards. It specifies the use of a single device transport protocol (IrDA TinyTP) running over two possible physical layers: IrDA-infrared, as specified by the Infrared Data Association (IrDA) and ISO/IEEE11073‑303002; and cable-connected, as specified by the IEEE 1073 lower-layers standard.3 This specification also utilizes local area networking standards such as IEEE 802.34 and protocols such as TCP/IP in cases where network connectivity is required.

Standards Relationship
CLSI POCT1 A2 : 2ED 2006 Identical
ISO 11073-90101:2008 Identical

CLSI AUTO13 A2 : 2ED 2003 LABORATORY INSTRUMENTS AND DATA MANAGEMENT SYSTEMS: DESIGN OF SOFTWARE USER INTERFACES AND END-USER SOFTWARE SYSTEMS VALIDATION, OPERATION, AND MONITORING
ISO/IEEE 11073-30300:2004 Health informatics — Point-of-care medical device communication — Part 30300: Transport profile — Infrared wireless
CLSI AST2 A : 1ED 99 POINT-OF-CARE IN VITRO DIAGNOSTIC (IVD) TESTING
IEEE 802.3-2012 IEEE Standard for Ethernet
CLSI HS3 A : 1ED 2005 PULSE OXIMETRY
IEEE 802.11-2016 IEEE Standard for Information technology--Telecommunications and information exchange between systems Local and metropolitan area networks--Specific requirements - Part 11: Wireless LAN Medium Access Control (MAC) and Physical Layer (PHY) Specifications
CLSI POCT13 A2 : 2ED 2005 GLUCOSE MONITORING IN SETTINGS WITHOUT LABORATORY SUPPORT
CLSI HS2 A : 1ED 2003 PROVIDER PERFORMED MICROSCOPY TESTING
CLSI C30 A2 : 2ED 2002 POINT-OF-CARE BLOOD GLUCOSE TESTING IN ACUTE AND CHRONIC CARE FACILITIES
ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
ISO/IEEE 11073-30200:2004 Health informatics — Point-of-care medical device communication — Part 30200: Transport profile — Cable connected

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