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1、BRITISH STANDARD BS EN ISO 22870:2006 Point-of-care testing (POCT) Requirements for quality and competence The European Standard EN ISO 22870:2006 has the status of a British Standard ICS 03.120.10; 11.100.01 ? Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 11:03:06 GMT+00:00 2006, Uncontrol
2、led Copy, (c) BSI BS EN ISO 22870:2006 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 March 2006 BSI 2006 ISBN 0 580 48059 3 National foreword This British Standard is the official English language version of EN ISO 22870:2006. It is iden
3、tical with ISO 22870:2006. The UK participation in its preparation was entrusted to Technical Committee CH/212, IVDs, which has the responsibility to: A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which imple
4、ment international or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. This publication doe
5、s not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible international/Europea
6、n committee any enquiries on the interpretation, or proposals for change, and keep UK interests informed; monitor related international and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the EN ISO title page, the E
7、N ISO foreword page, the ISO title page, pages ii to v, a blank page, pages 1 to 11 and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. DateComments Licensed Copy: sheffieldun sheffieldun, na,
8、 Wed Nov 15 11:03:06 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 22870 February 2006 ICS 03.120.10; 11.100.01 English Version Point-of-care testing (POCT) - Requirements for quality and competence (ISO 22870:2006) Analyses de biologie dlocalise
9、s (ADBD) - Exigences concernant la qualit et la comptence (ISO 22870:2006) Patientennahe Untersuchungen (point-of-care testing, POCT) - Anforderungen an Qualitt und Kompetenz (ISO 22870:2006) This European Standard was approved by CEN on 23 January 2006. CEN members are bound to comply with the CEN/
10、CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to a
11、ny CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official versions.
12、CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Sw
13、itzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2006 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref.
14、 No. EN ISO 22870:2006: E Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 11:03:06 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Foreword This document (EN ISO 22870:2006) has been prepared by Technical Committee ISO/TC 212 “Clinical laboratory testing and in vitro diagnostic test systems“ in co
15、llaboration with Technical Committee CEN/TC 140 “In vitro diagnostic medical devices“, the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by August 2006, and con
16、flicting national standards shall be withdrawn at the latest by August 2006. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, F
17、inland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Endorsement notice The text of ISO 22870:2006 has been approved by CEN as EN ISO
18、 22870:2006 without any modifications. EN ISO 22870:2006 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 11:03:06 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Reference number ISO 22870:2006(E) INTERNATIONAL STANDARD ISO 22870 First edition 2006-02-01 Point-of-care testing (POCT) Requirements f
19、or quality and competence Analyses de biologie dlocalises (ADBD) Exigences concernant la qualit et la comptence EN ISO 22870:2006 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 11:03:06 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 11:03
20、:06 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iii Contents Page Foreword iv Introduction v 1 Scope 1 2 Normative references1 3 Terms and definitions .1 4 Management requirements.1 5 Technical requirements 6 Bibliography11 EN ISO 22870:2006 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 11:0
21、3:06 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iv 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. Eac
22、h 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 non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the Internation
23、al 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 Standard
24、s 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 o
25、f patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 22870 was prepared by Technical Committee ISO/TC TC 212, Clinical laboratory testing and in vitro diagnostic test systems. EN ISO 22870:2006 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 11
26、:03:06 GMT+00:00 2006, Uncontrolled Copy, (c) BSI v Introduction Traditional examinations of a patients body fluids, excreta and tissues are carried out generally in the controlled and regulated environment of a recognized medical laboratory. The introduction of quality management systems and accred
27、itation of these laboratories are gaining increasing interest. Advances in technology have resulted in compact, easy-to-use in vitro diagnostic (IVD) medical devices that make it possible to carry out some examinations at, or close to, the location of the patient. Point-of-care/near- patient testing
28、 may benefit the patient as well as healthcare facilities. Risk to the patient and to the facility can be managed by a well-designed, fully implemented quality management system that facilitates: ? evaluation of new or alternative POCT instruments and systems, ? evaluation and approval of end-user p
29、roposals and protocols, ? purchase and installation of equipment, ? maintenance of consumable supplies and reagents, ? training, certification and recertification of POCT system operators, ? quality control and quality assurance. Bodies that recognise the competence of POCT facilities may use this I
30、nternational Standard as the basis for their activities. If a healthcare facility seeks accreditation for a part or all of its activities, it should select an accreditation body that operates in a manner which takes into account the special requirements of POCT. EN ISO 22870:2006 Licensed Copy: shef
31、fieldun sheffieldun, na, Wed Nov 15 11:03:06 GMT+00:00 2006, Uncontrolled Copy, (c) BSI blank Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 11:03:06 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 1 Point-of-care testing (POCT) Requirements for quality and competence 1 Scope This International S
32、tandard gives specific requirements applicable to point-of-care testing and is intended to be used in conjunction with ISO 15189. The requirements of this International Standard apply when POCT is carried out in hospital, clinic and by a healthcare organization providing ambulatory care. This Intern
33、ational Standard can be applied to transcutaneous measurements, the analysis of expired air, and in vivo monitoring of physiological parameters. Patient self-testing in a home or community setting is excluded, but elements of this International Standard can be applicable. NOTE Local, regional, and n
34、ational regulations are to be taken into consideration. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (inclu
35、ding any amendments) applies. ISO 15189:2003, Medical laboratories Particular requirements for quality and competence 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 point-of-care testing POCT near-patient testing testing that is performed ne
36、ar or at the site of a patient with the result leading to possible change in the care of the patient 4 Management requirements 4.1 Organization and management 4.1.1 ISO 15189:2003, 4.1.1, and the following apply. The management of laboratory services shall plan and develop the processes needed for P
37、OCT. The following shall be considered, as appropriate: a) quality objectives and requirements for POCT; EN ISO 22870:2006 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 11:03:06 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 2 b) the need to establish processes and documents, and provide resour
38、ces specific to POCT; c) required verification, validation, and monitoring of activities specific to POCT; d) records to provide evidence that POCT processes and procedures meet requirements. The governing body of the organization shall be ultimately responsible for ensuring that appropriate measure
39、s are in place to monitor the accuracy and quality of POCT conducted within the healthcare organization. 4.1.2 ISO 15189:2003, 4.1.2, and the following subclauses 4.1.2.1 to 4.1.2.5 apply. 4.1.2.1 A health professional grouping (e.g. Medical Advisory Committee) shall be responsible to the governing
40、body, for defining the scope of POCT to be made available. This shall take into consideration the clinical need for POCT, its financial implications, technical feasibility, and the ability of the organization to fulfil the need. 4.1.2.2 The laboratory director or designate shall appoint a multidisci
41、plinary POCT management group with representation from the laboratory, administration, and clinical programmes including nursing to advise on the provision of POCT. 4.1.2.3 The management group shall ensure that responsibilities and authorities are defined and communicated within the organization. 4
42、.1.2.4 The management group shall assist in evaluating and selecting POCT devices and systems. Performance criteria for POCT devices should include consideration of trueness, precision, detection limits, use limits, and interferences. Practicability should also be considered. 4.1.2.5 The management
43、group shall consider all proposals to introduce any product, device, or system for POCT. 4.1.3 ISO 15189:2003, 4.1.3 applies. 4.2 Quality management system 4.2.1 ISO 15189:2003, 4.2, and the following subclauses 4.2.2 to 4.2.5 apply. 4.2.2 The management of laboratory services shall establish, docum
44、ent, implement and maintain a quality management system and continually improve its effectiveness. 4.2.2.1 The management of laboratory services shall a) identify the processes needed for the quality management system for POCT throughout the organization, b) determine the sequence and interaction of
45、 these processes, c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective, d) ensure the availability of resources and information necessary to support the operation and monitoring of these processes, e) monitor, measure and analyse the
46、se processes, f) implement actions necessary to achieve planned results and continual improvement of these processes, g) appoint a person with appropriate training and experience, as quality manager responsible for POCT quality, which includes review of the requirements related to POCT. EN ISO 22870
47、:2006 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 11:03:06 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 3 These processes shall be managed by the organization in accordance with the requirements of this International Standard. Processes needed for the quality management system referred to a
48、bove should include processes for management activities, provision of resources, service provisions, and measurement provisions. 4.2.2.2 The management of laboratory services shall plan and implement the monitoring, measurement, analysis, and improvement processes needed to demonstrate conformity of
49、 POCT to the quality system. 4.2.3 The quality management system documentation shall include: a) documented statements of a quality policy and quality objectives; b) quality manual; c) documented procedures required by this International Standard; d) documents needed by the organization to ensure the effective planning, operation, and control of its processes; e) records required by this International Standard. NOTE Within this International Standard, the term “documented procedu