DIN EN ISO 22870-2017 Point-of-care testing (POCT) - Requirements for quality and competence (ISO 22870 2016) German version EN ISO 22870 2016《护理点试验(POCT) 质量和能力要求(ISO 22870-2016) 德.pdf

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1、April 2017 English price group 12No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 03.120.10; 11.100.01!%c8“2649921ww

2、w.din.deDIN EN ISO 22870Pointofcare testing (POCT) Requirements for quality and competence (ISO 22870:2016);English version EN ISO 22870:2016,English translation of DIN EN ISO 22870:2017-04Patientennahe Untersuchungen (pointofcare testing, POCT) Anforderungen an Qualitt und Kompetenz (ISO 22870:2016

3、);Englische Fassung EN ISO 22870:2016,Englische bersetzung von DIN EN ISO 22870:2017-04Examens de biologie mdicale dlocalise (EBMD) Exigences concernant la qualit et la comptence (ISO 22870:2016);Version anglaise EN ISO 22870:2016,Traduction anglaise de DIN EN ISO 22870:2017-04SupersedesDIN EN ISO 2

4、2870:200606www.beuth.deDocument comprises 20 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.04.17 DIN EN ISO 22870:2017-04 2 A comma is used as the decimal marker. National foreword This document (EN ISO 22870:2016) has been p

5、repared by Technical Committee ISO/TC 212 “Clinical laboratory testing and in vitro diagnostic test systems” (Secretariat: ANSI, USA) in collaboration with Technical Committee CEN/TC 140 “In vitro diagnostic medical devices” (Secretariat: DIN, Germany) with the active participation of German experts

6、. The responsible German body involved in its preparation was DIN-Normenausschuss Medizin (DIN Standards Committee Medicine), Working Committee NA 063-03-11 AA “Point-of-Care-Testing (POCT)”. The DIN Standards corresponding to the International Standards referred to in this document are as follows:

7、ISO 15189:2012 DIN EN ISO 15189:2014-11 ISO/IEC 17043:2010 DIN EN ISO/IEC 17043:2010-05 ISO 18113-4 DIN EN ISO 18113-4 ISO 18113-5 DIN EN ISO 18113-5 Amendments This standard differs from DIN EN ISO 22870:2006-06 as follows: a) cross-references to the applicable clauses of ISO 15189:2012 have been u

8、pdated; b) reference to ISO/IEC Guide 43-1 has been replaced by reference to ISO/IEC 17043:2010; c) the Bibliography has been updated. Previous editions DIN EN ISO 22870: 2006-06 DIN EN ISO 22870:2017-04 3 National Annex NA (informative) Bibliography DIN EN ISO 15189:2014-11, Medical laboratories Re

9、quirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15) DIN EN ISO/IEC 17043:2010-05, Conformity assessment General requirements for proficiency testing (ISO/IEC 17043:2010) DIN EN ISO 18113-4, In vitro diagnostic medical devices Information supplied by the manufacturer

10、(labelling) Part 4: In vitro diagnostic reagents for self-testing DIN EN ISO 18113-5, In vitro diagnostic medical devices Information supplied by the manufacturer (labelling) Part 5: In vitro diagnostic instruments for self-testing DIN EN ISO 22870:2017-04 4 This page is intentionally blank EUROPEAN

11、 STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 22870 November 2016 ICS 03.120.10; 11.100.01 Supersedes EN ISO 22870:2006English Version Point-of-care testing (POCT) - Requirements for quality and competence (ISO 22870:2016) Examens de biologie mdicale dlocalise (EBMD) - Exigences concernant la qua

12、lit et la comptence(ISO 22870:2016) Patientennahe Untersuchungen (point-of-care testing, POCT) - Anforderungen an Qualitt und Kompetenz (ISO 22870:2016) This European Standard was approved by CEN on 14 October 2016. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stip

13、ulate 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 CEN-CENELEC Management Centre or to any CEN member. This European

14、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 CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the

15、 national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania

16、, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2016 CEN All rights of exploitation in any form and by an

17、y means reserved worldwide for CEN national Members. Ref. No. EN ISO 22870:2016 EEuropean foreword .3Introduction 51 Scope . 62 Normative references 63 Terms and definitions . 64 Management requirements . 64.1 Organization and management 64.2 Quality management system . 74.3 Document control . 94.4

18、Service agreements . 94.5 Examination by referral laboratories 94.6 External services and supplies 94.7 Advisory services 94.8 Resolution of complaints 94.9 Identification and control of nonconformities 94.10 Corrective action 104.11 Preventive action 104.12 Continual improvement . 104.13 Quality an

19、d technical records 104.14 Internal audits 114.15 Management review 115 Technical requirements . 115.1 Personnel 115.2 Accommodation and environmental conditions 135.3 Equipment 135.4 Pre-examination procedures . 135.5 Examination procedures . 135.6 Assuring the quality of examination procedures . 1

20、45.7 Post-examination procedure 145.8 Reporting of results . 15Bibliography .16Contents PageDIN EN ISO 22870:2017-04 EN ISO 22870:2016 (E) 2Foreword 4European foreword This document (EN ISO 22870:2016) has been prepared by Technical Committee ISO/TC 212 “Clinical laboratory testing and in vitro diag

21、nostic test systems“ in collaboration 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 lates

22、t by May 2017, and conflicting national standards shall be withdrawn at the latest by November 2019. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such

23、patent rights. This document supersedes EN ISO 22870:2006. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EC Regulation 765/2008. According to the CEN-CENELEC Internal Regulations

24、, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, L

25、atvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 22870:2016 has been approved by CEN as EN ISO 22870:2016 without any modification. DIN EN ISO 22870:2

26、017-04 EN ISO 22870:2016 (E) 3 ForewordISO (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 interes

27、ted 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 International Electrotechnical C

28、ommission (IEC) on all matters of electrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO document

29、s should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).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 f

30、or identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).Any trade name used in this document is information given for the

31、convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT)

32、see the following URL: www.iso.org/iso/foreword.html.The committee responsible for this document is ISO/TC 212, Clinical laboratory testing and in vitro diagnostic test systems.This second edition cancels and replaces the first edition (ISO 22870:2006), of which it constitutes a minor revision.The c

33、hanges compared to the previous edition are as follows: inclusion of cross-references to the applicable clauses in ISO 15189:2012.DIN EN ISO 22870:2017-04 EN ISO 22870:2016 (E) 4 IntroductionTraditional examinations of a patients body fluids, excreta and tissues are carried out generally in the cont

34、rolled and regulated environment of a recognized medical laboratory. The introduction of quality management systems and accreditation 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

35、 it possible to carry out some examinations at, or close to, the location of the patient. Point-of-care/near-patient testing 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

36、 that facilitates evaluation of new or alternative POCT instruments and systems, evaluation and approval of end-user proposals and protocols, purchase, installation and maintenance of equipment, maintenance of consumable supplies and reagents, training, certification and recertification of POCT syst

37、em operators, and quality control and quality assurance.Bodies that recognize the competence of POCT facilities may use this document 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 opera

38、tes in a manner which takes into account the special requirements of POCT.DIN EN ISO 22870:2017-04 EN ISO 22870:2016 (E) 5 1 ScopeThis document gives specific requirements applicable to point-of-care testing and is intended to be used in conjunction with ISO 15189. The requirements of this document

39、apply when POCT is carried out in a hospital, clinic and by a healthcare organization providing ambulatory care. This document 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 se

40、tting is excluded, but elements of this document can be applicable.NOTE Local, regional and national regulations are to be taken into consideration.2 Normative referencesThe following documents are referred to in the text in such a way that some or all of their content constitutes requirements of th

41、is document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 15189:2012, Medical laboratories Requirements for quality and competence3 Terms and definitionsFor the purposes of this docu

42、ment, the following terms and definitions apply.ISO and IEC maintain terminological databases for use in standardization at the following addresses: IEC Electropedia: available at http:/www.electropedia.org/ ISO Online browsing platform: available at http:/www.iso.org/obp 3.1point-of-care testingPOC

43、Tnear-patient testingtesting that is performed near or at the site of a patient with the result leading to possible change in the care of the patient4 Management requirements4.1 Organization and management4.1.1 ISO 15189:2012, 4.1.1.2, 4.1.1.3 and the following apply.The management of laboratory ser

44、vices shall plan and develop the processes needed for POCT.The following shall be considered, as appropriate:a) quality objectives and requirements for POCT;DIN EN ISO 22870:2017-04 EN ISO 22870:2016 (E) 6 b) the need to establish processes and documents, and provide resources specific to POCT;c) re

45、quired 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 measures are in place to monitor the

46、 accuracy and quality of POCT conducted within the healthcare organization.4.1.2 ISO 15189:2012, 4.1.2.2, and the following subclauses apply.4.1.2.1 A health professional grouping (e.g. Medical Advisory Committee) shall be responsible to the governing body for defining the scope of POCT to be made a

47、vailable. 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 multidisciplinary POCT management group with representation f

48、rom 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.4.1.2.4 The management group shall assist in evaluating and selecting POCT devices and systems. Performance criteria for POCT devices should include consideration of trueness, precision, detectio