ISO 11073-90101:2008
(Main)Health informatics — Point-of-care medical device communication — Part 90101: Analytical instruments — Point-of-care test
Health informatics — Point-of-care medical device communication — Part 90101: Analytical instruments — Point-of-care test
ISO 11073-90101:2008 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, ISO 11073-90101:2008 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 International Standard does not directly address specific point-of-care application and service level functions, such as device lockout and operator list management. It 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.
Informatique de santé — Communication entre dispositifs médicaux sur le site des soins — Partie 90101: Instruments analytiques — Essai sur le site des soins
General Information
Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 11073-90101
First edition
2008-01-15
Health informatics — Point-of-care
medical device communication —
Part 90101:
Analytical instruments — Point-of-care
test
Informatique de santé — Communication entre dispositifs médicaux sur
le site des soins —
Partie 90101: Instruments analytiques — Essai sur le site des soins
Reference number
ISO 11073-90101:2008(E)
©
ISO 2008
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ISO 11073-90101:2008(E)
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ISO 11073-90101:2008(E)
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
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International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
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 drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 11073-90101 was prepared by the Clinical and Laboratory Standards Institute (as POCT1-A2) and was
adopted, under a special “fast-track procedure”, by Technical Committee ISO/TC 215, Health informatics, in
parallel with its approval by the ISO member bodies.
© ISO 2008 – All rights reserved iii
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ISO 11073-90101:2008(E)
POCT1-A2
Vol. 26 No. 28
Replaces POCT1-A
Vol. 21 No. 24
Point-of-Care Connectivity; Approved
Standard—Second Edition
This document provides the framework for engineers to design devices, work stations,
and interfaces that allow multiple types and brands of point-of-care devices to
communicate bidirectionally with access points, data managers, and laboratory
information systems from a variety of vendors.
A standard for global application developed through the Clinical and Laboratory
Standards Institute consensus process.
(Formerly NCCLS)
© ISO 2008 – All rights reserved
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ISO 11073-90101:2008(E)
Clinical and Laboratory Standards Institute
Advancing Quality in Healthcare Testing
The Clinical and Laboratory Standards Institute (CLSI, Most documents are subject to two levels of consensus—
formerly NCCLS) is an international, interdisciplinary, “proposed” and “approved.” Depending on the need for
nonprofit, standards-developing, and educational field evaluation or data collection, documents may also be
organization that promotes the development and use of made available for review at an intermediate consensus
voluntary co
...
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