1、BRITISH STANDARDBS ISO 11073-90101: 2008Health informatics Point-of-care medical device communication Part 90101: Analytical instruments Point-of-care testICS 35.240.80g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g
2、53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58BS ISO 11073-90101:2008This British Standard was published under the authority of the Standards Policy and Strategy Committee on 29 February 2008 BSI 2008ISBN 978 0 580 53679 3National forewordThis British Standard is the UK impleme
3、ntation of ISO 11073-90101:2008.The UK participation in its preparation was entrusted to Technical Committee IST/35, Health informatics.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary pro
4、visions of a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunity from legal obligations. Amendments/corrigenda issued since publicationDate CommentsReference numberISO 11073-90101:2008(E)INTERNATIONAL STANDARD ISO11073-90101First edit
5、ion2008-01-15Health informatics Point-of-care medical device communication Part 90101: Analytical instruments Point-of-care test Informatique de sant Communication entre dispositifs mdicaux sur le site des soins Partie 90101: Instruments analytiques Essai sur le site des soins BS ISO 11073-90101:200
6、8ii iiiForeword 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 wh
7、ich a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all
8、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 ci
9、rculated 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 respo
10、nsible 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
11、 member bodies. BS ISO 11073-90101:2008blankPOCT1-A2 Vol. 26 No. 28 Replaces POCT1-A Vol. 21 No. 24 Point-of-Care Connectivity; Approved StandardSecond Edition This document provides the framework for engineers to design devices, work stations, and interfaces that allow multiple types and brands of
12、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) BS ISO 11073-9
13、0101:2008Clinical and Laboratory Standards Institute Advancing Quality in Healthcare Testing The Clinical and Laboratory Standards Institute (CLSI, formerly NCCLS) is an international, interdisciplinary, nonprofit, standards-developing, and educational organization that promotes the development and
14、use of voluntary consensus standards and guidelines within the healthcare community. It is recognized worldwide for the application of its unique consensus process in the development of standards and guidelines for patient testing and related healthcare issues. Our process is based on the principle
15、that consensus is an effective and cost-effective way to improve patient testing and healthcare services. In addition to developing and promoting the use of voluntary consensus standards and guidelines, we provide an open and unbiased forum to address critical issues affecting the quality of patient
16、 testing and health care. PUBLICATIONS A document is published as a standard, guideline, or committee report. Standard A document developed through the consensus process that clearly identifies specific, essential requirements for materials, methods, or practices for use in an unmodified form. A sta
17、ndard may, in addition, contain discretionary elements, which are clearly identified. Guideline A document developed through the consensus process describing criteria for a general operating practice, procedure, or material for voluntary use. A guideline may be used as written or modified by the use
18、r to fit specific needs. Report A document that has not been subjected to consensus review and is released by the Board of Directors. CONSENSUS PROCESS The CLSI voluntary consensus process is a protocol establishing formal criteria for: the authorization of a project the development and open review
19、of documents the revision of documents in response to comments by users the acceptance of a document as a consensus standard or guideline. Most documents are subject to two levels of consensus“proposed” and “approved.” Depending on the need for field evaluation or data collection, documents may also
20、 be made available for review at an intermediate consensus level. Proposed A consensus document undergoes the first stage of review by the healthcare community as a proposed standard or guideline. The document should receive a wide and thorough technical review, including an overall review of its sc
21、ope, approach, and utility, and a line-by-line review of its technical and editorial content. Approved An approved standard or guideline has achieved consensus within the healthcare community. It should be reviewed to assess the utility of the final document, to ensure attainment of consensus (i.e.,
22、 that comments on earlier versions have been satisfactorily addressed), and to identify the need for additional consensus documents. Our standards and guidelines represent a consensus opinion on good practices and reflect the substantial agreement by materially affected, competent, and interested pa
23、rties obtained by following CLSIs established consensus procedures. Provisions in CLSI standards and guidelines may be more or less stringent than applicable regulations. Consequently, conformance to this voluntary consensus document does not relieve the user of responsibility for compliance with ap
24、plicable regulations. COMMENTS The comments of users are essential to the consensus process. Anyone may submit a comment, and all comments are addressed, according to the consensus process, by the committee that wrote the document. All comments, including those that result in a change to the documen
25、t when published at the next consensus level and those that do not result in a change, are responded to by the committee in an appendix to the document. Readers are strongly encouraged to comment in any form and at any time on any document. Address comments to the Clinical and Laboratory Standards I
26、nstitute, 940 West Valley Road, Suite 1400, Wayne, PA 19087, USA. VOLUNTEER PARTICIPATION Healthcare professionals in all specialties are urged to volunteer for participation in CLSI projects. Please contact us at customerserviceclsi.org or +610.688.0100 for additional information on committee parti
27、cipation. BS ISO 11073-90101:2008POCT1-A2 ISBN 1-56238-616-6 Volume 26 Number 28 ISSN 0273-3099 Point-of-Care Connectivity; Approved StandardSecond Edition Lou Dunka, PhD Bryan Allen Todd Cooper Christopher Fetters Wayne Mullins James Nichols, PhD Thomas Norgall Paul Schluter, PhD Robert Uleski Abst
28、ract Clinical and Laboratory Standards Institute document POCT1-A2, Point-of-Care Connectivity; Approved StandardSecond Edition was developed for those engaged in the manufacture of point-of-care diagnostic devices, as well as the hardware and software used to connect the devices to various informat
29、ion systems in healthcare facilities. This document incorporates the work product of the Connectivity Industry Consortium, an organization that developed specifications for point-of-care device and information system communication interoperability. It provides the basis for multivendor, seamless int
30、eroperability between point-of-care devices, data managers, and clinical results management systems. Clinical and Laboratory Standards Institute (CLSI). Point-of-Care Connectivity; Approved StandardSecond Edition. CLSI document POCT1-A2 (ISBN 1-56238-616-6). Clinical and Laboratory Standards Institu
31、te, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2006. (Formerly NCCLS) The Clinical and Laboratory Standards Institute consensus process, which is the mechanism for moving a document through two or more levels of review by the healthcare community, is an ongoing process. Us
32、ers should expect revised editions of any given document. Because rapid changes in technology may affect the procedures, methods, and protocols in a standard or guideline, users should replace outdated editions with the current editions of CLSI/NCCLS documents. Current editions are listed in the CLS
33、I catalog, which is distributed to member organizations, and to nonmembers on request. If your organization is not a member and would like to become one, and to request a copy of the catalog, contact us at: Telephone: 610.688.0100; Fax: 610.688.0700; E-Mail: customerserviceclsi.org; Website: www.cls
34、i.org BS ISO 11073-90101:2008Number 28 POCT1-A2ii This publication is protected by copyright. No part of it may be reproduced, stored in a retrieval system, transmitted, or made available in any form or by any means (electronic, mechanical, photocopying, recording, or otherwise) without prior writte
35、n permission from Clinical and Laboratory Standards Institute, except as stated below. Clinical and Laboratory Standards Institute hereby grants permission to reproduce limited portions of this publication for use in laboratory procedure manuals at a single site, for interlibrary loan, or for use in
36、 educational programs provided that multiple copies of such reproduction shall include the following notice, be distributed without charge, and, in no event, contain more than 20% of the documents text. Reproduced with permission, from CLSI publication POCT1-A2Point-of-Care Connectivity; Approved St
37、andardSecond Edition (ISBN 1-56238-616-6). Copies of the current edition may be obtained from Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898, USA. Permission to reproduce or otherwise use the text of this document to an extent that excee
38、ds the exemptions granted here or under the Copyright Law must be obtained from Clinical and Laboratory Standards Institute by written request. To request such permission, address inquiries to the Executive Vice President, Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400
39、, Wayne, Pennsylvania 19087-1898, USA. Copyright 2006. Clinical and Laboratory Standards Institute. Suggested Citation (Clinical and Laboratory Standards Institute. Point-of-Care Connectivity; Approved StandardSecond Edition. CLSI document POCT1-A2 ISBN 1-56238-616-6. Clinical and Laboratory Standar
40、ds Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2006.) Proposed Standard May 2001 Approved Standard December 2001 Approved StandardSecond Edition July 2006 ISBN 1-56238-616-6 ISSN 0273-3099 BS ISO 11073-90101:2008Volume 26 POCT1-A2iiiCommittee Membership Area Comm
41、ittee on Point-of-Care Testing Louis J. Dunka, Jr, PhD Chairholder LifeScan, Inc. Milpitas, California James H. Nichols, PhD, DABCC, FACB Vice Chairholder Baystate Medical Center Springfield, Massachusetts Diana R. DeHoyos, MS, MT(ASCP) The University of Texas Medical Branch Galveston, Texas Christo
42、pher Fetters NOVA Biomedical Waltham, Massachusetts George W. Gaebler, III, MSEd., RRT, FAARC University Hospital Syracuse, New York Ethan D. Hausman, MD, FAAP, FCAP FDA Ctr. for Devices/Rad. Health Rockville, Maryland Frank M. LaDuca, PhD Bayer HealthCare Diagnostics Division Tarrytown, New York Ra
43、elene M. Perfetto, MBA, MT(ASCP) Centers for Medicare Appendixes D and E describe the basic concepts CIC employed to develop this standard. aThe governing principles, guidelines, timeline, and other information about the CIC can be found at the CICs website: www.poct.fraunhofer.de/about/index.html.
44、The CIC development process emulated the standards-development processes of ANSI-approved standards organizations. BS ISO 11073-90101:2008Number 28 POCT1-A2x Foreword (Continued) Note that the following trade names are included in this document: PalmTM, Pocket PCTM, and BluetoothTM.It is CLSI policy
45、 to avoid using trade names unless the products identified are the only ones available; they serve as an example of the point illustrated in the consensus document; and there is no generic description of the design and functional features of the products. Inclusion of these trade names in no way con
46、stitutes endorsement by CLSI. Please include in your comments any information that relates to our adherence to this trade name policy. Connectivity Industry Consortium Membership CORE VENDORS CORE PROVIDERS Abbott Laboratories Banner Health System Agilent Technologies Bradford Royal Infirmary Bayer
47、Diagnostics Geisinger Healthcare System BD John Hopkins Medical Institutions Instrumentation Laboratory Kaiser Permanente Lifescan/J however, at that time it wasnt clear whether one technology should be chosen in favor of another. As a result, though RF wireless networking is mentioned in the docume
48、nt, there is no clear direction other than that the standard should be easily extended to include one or more of these transport technologies as long as they provide reliable connection-oriented communications. This document replaces the first approved edition, POCT1-A, which was published in 2001.
49、Several changes have been made in this edition; chief among them is the addition of a new section related to RF Wireless Networking Technologies (see Section 12 in Appendix A). Another significant change in this document is the conversion of each message prefix from “NCCLS” to “CLSI.” This change has been made to reflect the organizational name change that has occurred since the original publication of this standard. In the case of manufacturers with existing or distributed implementations that used the “NCCLS
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