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1、BRITISH STANDARD BS ISO 11073-90101: 2008 Health informatics Point-of-care medical device communication Part 90101: Analytical instruments Point-of-care test ICS 35.240.80 ? Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boeing Co/59107700
2、01 Not for Resale, 08/14/2008 22:10:57 MDTNo reproduction or networking permitted without license from IHS -,-,- BS ISO 11073-90101:2008 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 29 February 2008 BSI 2008 ISBN 978 0 580 53679 3 National
3、 foreword This British Standard is the UK implementation 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 publicati
4、on does not purport to include all the necessary provisions 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 publication DateComments Copyright British Standards Inst
5、itution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boeing Co/5910770001 Not for Resale, 08/14/2008 22:10:57 MDTNo reproduction or networking permitted without license from IHS -,-,- Reference number ISO 11073-90101:2008(E) INTERNATIONAL STANDARD ISO 11073-90101 First edition
6、 2008-01-15 Health 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 11073-90101:2008
7、 Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boeing Co/5910770001 Not for Resale, 08/14/2008 22:10:57 MDTNo reproduction or networking permitted without license from IHS -,-,- ii Copyright British Standards Institution Provided by IHS u
8、nder license with BSI - Uncontrolled Copy Licensee=Boeing Co/5910770001 Not for Resale, 08/14/2008 22:10:57 MDTNo reproduction or networking permitted without license from IHS -,-,- iii Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards
9、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 organizat
10、ions, 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 matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in th
11、e 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
12、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 Standar
13、ds 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. BS ISO 11073-90101:2008 Copyright British Standards Institution Provided by IHS under license with BSI -
14、Uncontrolled Copy Licensee=Boeing Co/5910770001 Not for Resale, 08/14/2008 22:10:57 MDTNo reproduction or networking permitted without license from IHS -,-,- blank Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boeing Co/5910770001 Not for
15、 Resale, 08/14/2008 22:10:57 MDTNo reproduction or networking permitted without license from IHS -,-,- POCT1-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 statio
16、ns, 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 I
17、nstitute consensus process. (Formerly NCCLS) BS ISO 11073-90101:2008 Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boeing Co/5910770001 Not for Resale, 08/14/2008 22:10:57 MDTNo reproduction or networking permitted without license from IH
18、S -,-,- Clinical 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 u
19、se 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 t
20、hat 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
21、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 stan
22、dard 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 user
23、 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 o
24、f 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
25、 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
26、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.,
27、 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
28、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
29、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
30、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
31、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
32、cipation. BS ISO 11073-90101:2008 Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boeing Co/5910770001 Not for Resale, 08/14/2008 22:10:57 MDTNo reproduction or networking permitted without license from IHS -,-,- POCT1-A2 ISBN 1-56238-616-6
33、 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 Abstract Clinical and Laboratory Standards Institute document PO
34、CT1-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 information systems in healthcare facilities. This document incorpor
35、ates 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 interoperability between point-of-care devices, data managers,
36、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 Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19
37、087-1898 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. Users should expect revised editions of any given document. Be
38、cause 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 CLSI catalog, which is distributed to member organizations, and
39、 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.clsi.org BS ISO 11073-90101:2008 Copyright British Standards In
40、stitution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boeing Co/5910770001 Not for Resale, 08/14/2008 22:10:57 MDTNo reproduction or networking permitted without license from IHS -,-,- Number 28 POCT1-A2 ii This publication is protected by copyright. No part of it may be repr
41、oduced, stored in a retrieval system, transmitted, or made available in any form or by any means (electronic, mechanical, photocopying, recording, or otherwise) without prior written permission from Clinical and Laboratory Standards Institute, except as stated below. Clinical and Laboratory Standard
42、s 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 educational programs provided that multiple copies of such reproduction shall include the following notice, be distrib
43、uted 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 StandardSecond Edition (ISBN 1-56238-616-6). Copies of the current edition may be obtained from Clinical and Laboratory S
44、tandards 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 exceeds the exemptions granted here or under the Copyright Law must be obtained from Clinical and Laboratory Standards Insti
45、tute 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, Wayne, Pennsylvania 19087-1898, USA. Copyright 2006. Clinical and Laboratory Standards Institute. Suggested Citation
46、(Clinical and Laboratory Standards Institute. Point-of-Care Connectivity; Approved StandardSecond Edition. CLSI document POCT1-A2 ISBN 1-56238-616-6. Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2006.) Proposed Standard May 2001 A
47、pproved Standard December 2001 Approved StandardSecond Edition July 2006 ISBN 1-56238-616-6 ISSN 0273-3099 BS ISO 11073-90101:2008 Copyright British Standards Institution Provided by IHS under license with BSI - Uncontrolled Copy Licensee=Boeing Co/5910770001 Not for Resale, 08/14/2008 22:10:57 MDTNo reproduction or networking permitted without license from IHS -,-,- Volume 26 POCT1-A2 iii Committee Membership Area Committee on Point-of-Care Testing Louis J. Dunka, Jr, PhD Chairholder LifeScan, Inc. Milpitas, California James H. Nichols, PhD, DABCC, FACB Vice Chairholder Baystate Me