EN ISO 22870:2016
(Main)Point-of-care testing (POCT) - Requirements for quality and competence (ISO 22870:2016)
Point-of-care testing (POCT) - Requirements for quality and competence (ISO 22870:2016)
ISO 22870:2016 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 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 setting is excluded, but elements of this document can be applicable.
Patientennahe Untersuchungen (point-of-care testing, POCT) - Anforderungen an Qualität und Kompetenz (ISO 22870:2016)
Dieses Dokument legt besondere Anforderungen fest, die für patientennahe Untersuchungen gelten, und ist zur Anwendung im Zusammenhang mit ISO 15189 vorgesehen. Die Anforderungen dieses Dokumentes gelten, wenn POCT in einem Krankenhaus oder einer Klinik erfolgen, und dürfen auch in einer Pflegeorganisation angewendet werden, die ambulante Patientenversorgung durchführt. Dieses Dokument kann für transkutane Messungen, die Analyse der Ausatemluft und die In vivo Überwachung physiologischer Parameter angewendet werden.
Die Selbstuntersuchung von Patienten in deren Heim oder in einer Gemeinschaftseinrichtung fällt nicht unter dieses Dokument, aber bestimmte seiner Elemente können dafür gelten.
ANMERKUNG Örtliche, regionale und nationale Bestimmungen sind zu berücksichtigen.
Examens de biologie médicale délocalisée (EBMD) - Exigences concernant la qualité et la compétence (ISO 22870:2016)
ISO 22870:2016 fournit des exigences spécifiques des examens de biologie médicale délocalisée et est destiné à être utilisé conjointement avec l'ISO 15189. Les exigences du présent document s'appliquent lorsque les EBMD sont réalisées dans un hôpital ou une clinique et par un organisme de santé prodiguant des soins ambulatoires. Le présent document peut s'appliquer à des mesurages transcutanés, à l'analyse de l'air expiré et à la surveillance in vivo de paramètres physiologiques.
L'auto-test par les patients à domicile ou dans un dispensaire est exclu- mais certains éléments du présent document peuvent s'appliquer.
Testiranje ob pacientu (POCT) - Zahteve za kakovost in kompetentnost (ISO 22870:2016)
Ta dokument podaja posebne zahteve, ki se uporabljajo za preskušanje ob preiskovancu (POCT), in se uporablja skupaj s standardom ISO 15189. Zahteve tega dokumenta se uporabljajo, kadar se preskušanje ob preiskovancu izvaja v bolnišnici, kliniki ali zdravstveni organizaciji, ki zagotavlja ambulantno nego. Ta dokument se lahko uporablja za transkutane meritve, analizo izdihnjenega zraka ter spremljanje fizioloških parametrov in vivo.
Preskušanje, ki ga bolnik izvaja sam doma ali v skupnem okolju, ni vključeno, vendar se lahko uporabijo nekateri deli tega dokumenta.
OPOMBA: Treba je upoštevati lokalne, regionalne in nacionalne predpise.
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SLOVENSKI STANDARD
01-februar-2017
1DGRPHãþD
SIST EN ISO 22870:2006
Testiranje ob pacientu (POCT) - Zahteve za kakovost in kompetentnost (ISO
22870:2016)
Point-of-care testing (POCT) - Requirements for quality and competence (ISO
22870:2016)
Patientennahe Untersuchungen (point-of-care testing, POCT) - Anforderungen an
Qualität und Kompetenz (ISO 22870:2016)
Analyse de biologie délocalisée (ADBD) - Exigences en matière de qualité et de
compétences (ISO 22870:2016)
Ta slovenski standard je istoveten z: EN ISO 22870:2016
ICS:
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
11.100.01 Laboratorijska medicina na Laboratory medicine in
splošno general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 22870
EUROPEAN STANDARD
NORME EUROPÉENNE
November 2016
EUROPÄISCHE NORM
ICS 03.120.10; 11.100.01 Supersedes EN ISO 22870:2006
English Version
Point-of-care testing (POCT) - Requirements for quality
and competence (ISO 22870:2016)
Examens de biologie médicale délocalisée (EBMD) - Patientennahe Untersuchungen (point-of-care testing,
Exigences concernant la qualité et la compétence (ISO POCT) - Anforderungen an Qualität und Kompetenz
22870:2016) (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 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 CEN-CENELEC Management Centre or to any 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 CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the 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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 22870:2016 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 22870:2016) has been prepared by Technical Committee ISO/TC 212 "Clinical
laboratory testing and in vitro diagnostic 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 latest 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 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, 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, Latvia, 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.
INTERNATIONAL ISO
STANDARD 22870
Second edition
2016-11-01
Point-of-care testing (POCT) —
Requirements for quality and
competence
Examens de biologie médicale délocalisée (EBMD) — Exigences
concernant la qualité et la compétence
Reference number
ISO 22870:2016(E)
©
ISO 2016
ISO 22870:2016(E)
© ISO 2016, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2016 – All rights reserved
ISO 22870:2016(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Management requirements . 1
4.1 Organization and management . 1
4.2 Quality management system . 2
4.3 Document control . 4
4.4 Service agreements . 4
4.5 Examination by referral laboratories . 4
4.6 External services and supplies . 4
4.7 Advisory services . 4
4.8 Resolution of complaints . 4
4.9 Identification and control of nonconformities . 4
4.10 Corrective action . 5
4.11 Preventive action . 5
4.12 Continual improvement . 5
4.13 Quality and technical records . 5
4.14 Internal audits . 6
4.15 Management review . 6
5 Technical requirements . 6
5.1 Personnel . 6
5.2 Accommodation and environmental conditions . 8
5.3 Equipment . 8
5.4 Pre-examination procedures . 8
5.5 Examination procedures . 8
5.6 Assuring the quality of examination procedures . 9
5.7 Post-examination procedure . . 9
5.8 Reporting of results .10
Bibliography .11
ISO 22870:2016(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 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.
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 documents 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 for 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 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 ISO’s adherence to the World Trade Organization (WTO) principles in the
Technical Barriers to Trade (TBT) 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 changes compared to the previous edition are as follows:
— inclusion of cross-references to the applicable clauses in ISO 15189:2012.
iv © ISO 2016 – All rights reserved
SIST EN ISO 2
...
SLOVENSKI SIST EN ISO 22870
STANDARD februar 2017
Testiranje ob pacientu (POCT) – Zahteve za kakovost in kompetentnost (ISO
22870:2016)
Point-of-care testing (POCT) – Requirements for quality and competence (ISO
22870:2016)
Patientennahe Untersuchungen (point-of-care testing, POCT) – Anforderungen an
Qualität und Kompetenz (ISO 22870:2016)
Examens de biologie médicale délocalisée (EBMD) – Exigences concernant la
qualité et la compétence (ISO 22870:2016)
Referenčna oznaka
ICS 03.120.10; 11.100.01 SIST EN ISO 22870 : 2017 (sl)
Nadaljevanje na strani II in od 1 do 21
© 2020-06: Slovenski inštitut za standardizacijo. Razmnoževanje ali kopiranje celote ali delov tega dokumenta ni dovoljeno.
SIST EN ISO 22870 : 2017
NACIONALNI UVOD
Standard SIST EN ISO 22870 (sl), Testiranje ob pacientu (POCT) – Zahteve za kakovost in
kompetentnost (ISO 22870:2016), 2017, ima status slovenskega standarda in je enakovreden
evropskemu standardu EN ISO 22870 (en), Point-of-care testing (POCT) – Requirements for quality
and competence (ISO 22870:2016), 2016.
Ta standard nadomešča SIST EN ISO 22870:2006.
NACIONALNI PREDGOVOR
Evropski standard EN ISO 22870:2016 je pripravil tehnični odbor Evropskega komiteja za
standardizacijo CEN/TC 140 Diagnostični sistemi in vitro (In vitro diagnostic systems). Slovenski
standard SIST EN ISO 22870:2017 je prevod evropskega standarda EN ISO 22870:2016. V primeru
spora glede besedila slovenskega prevoda v tem standardu je odločilen izvirni evropski standard v enem
izmed treh uradnih jezikov CEN. Slovensko izdajo standarda je pripravil tehnični odbor SIST/TC VAZ
Varovanje zdravja.
Odločitev za izdajo tega standarda je dne 20. decembra 2016 sprejel SIST/TC VAZ Varovanje zdravja.
ZVEZE S STANDARDI
S privzemom tega evropskega standarda veljajo za omejeni namen referenčnih standardov vsi
standardi, navedeni v izvirniku, razen tistih, ki so že sprejeti v nacionalno standardizacijo:
SIST EN ISO 15189:2013 Medicinski laboratoriji – Zahteve za kakovost in kompetentnost
OSNOVA ZA IZDAJO STANDARDA
– privzem standarda EN ISO 22870:2016
PREDHODNA IZDAJA
– standard SIST EN ISO 22870:2006
OPOMBE
– Povsod, kjer se v besedilu standarda uporablja izraz “evropski standard”, v SIST EN ISO 22870:2017
to pomeni “slovenski standard”.
– Uvod in nacionalni predgovor nista sestavni del standarda.
– Ta nacionalni dokument je istoveten EN ISO 22870:2016 in je objavljen z dovoljenjem
Upravni center
CEN-CENELEC
Avenue Marnix 17
B-1000 Bruselj
This national document is identical with EN ISO 22870:2016 and is published with the
permission of
CEN-CENELEC
Management Centre
Avenue Marnix 17
B-1000 Brussels
II
EVROPSKI STANDARD EN ISO 22870
EUROPEAN STANDARD
NORME EUROPÉENNE
november 2016
EUROPÄISCHE NORM
ICS 03.120.10; 11.100.01 Nadomešča EN ISO 22870:2006
Slovenska izdaja
Testiranje ob pacientu (POCT) – Zahteve za kakovost in kompetentnost
(ISO 22870:2016)
Point-of-care testing (POCT) – Examens de biologie médicale Patientennahe Untersuchungen
Requirements for quality and délocalisée (EBMD) – (point-of-care testing, POCT) –
competence (ISO 22870:2016) Exigences concernant la qualité Anforderungen an Qualität und
et la compétence (ISO Kompetenz (ISO 22870:2016)
22870:2016)
Ta evropski standard je CEN sprejel 14. oktobra 2016.
Člani CEN morajo izpolnjevati notranje predpise CEN/CENELEC, s katerimi je predpisano, da mora biti ta
evropski standard brez kakršnih koli sprememb sprejet kot nacionalni standard. Najnovejši seznami teh
nacionalnih standardov z njihovimi bibliografskimi podatki se na zahtevo lahko dobijo pri Upravnem centru
CEN-CENELEC ali pri katerem koli članu CEN.
Ta evropski standard obstaja v treh uradnih izdajah (angleški, francoski in nemški). Izdaje v drugih jezikih, ki
jih člani CEN na lastno odgovornost prevedejo in izdajo ter prijavijo pri Upravnem centru CEN-CENELEC,
veljajo kot uradne izdaje.
Člani CEN so nacionalni organi za standarde Avstrije, Belgije, Bolgarije, Cipra, Češke republike, Danske,
Estonije, Finske, Francije, Grčije, Hrvaške, Irske, Islandije, Italije, Latvije, Litve, Luksemburga, Madžarske,
Malte, Nekdanje jugoslovanske republike Makedonije, Nemčije, Nizozemske, Norveške, Poljske,
Portugalske, Romunije, Slovaške, Slovenije, Španije, Švedske, Švice, Turčije in Združenega kraljestva.
CEN
Evropski komite za standardizacijo
European committee for standardization
Comité européen de normalisation
Europäisches komitee für normung
Upravni center CEN-CENELEC: Avenue Marnix 17, B-1000 Bruselj
© 2016 CEN Lastnice avtorskih pravic so vse države članice CEN. Ref. oznaka EN ISO 22870:2016 E
SIST EN ISO 22870 : 2017
VSEBINA Stran CONTENTS Page
Evropski predgovor . 3 European foreword . 3
Predgovor . 4 Foreword . 4
Uvod . 5 Introduction . 5
1 Področje uporabe . 6 1 Scope . 6
2 Zveza z drugimi standardi . 6 2 Normative references . 6
3 Izrazi in definicije . 6 3 Terms and definitions . 6
4 Zahteve za vodenje . 7 4 Management requirements . 7
4.1 Organizacija in vodenje . 7 4.1 Organization and management . 7
4.2 Sistem vodenja kakovosti . 8 4.2 Quality management system . 8
4.3 Obvladovanje dokumentov . 10 4.3 Document control . 10
4.4 Storitvene pogodbe . 10 4.4 Service agreements . 10
4.5 Preiskava, ki jo opravijo prejemni 4.5 Examination by referral laboratories . 10
laboratoriji . 10
4.6 Zunanje storitve in nabava materialnih 4.6 External services and supplies . 10
sredstev . 10
4.7 Svetovanje . 10 4.7 Advisory services . 10
4.8 Reševanje pritožb . 10 4.8 Resolution of complaints . 10
4.9 Identifikacija in obvladovanje 4.9 Identification and control of
neskladnosti . 10 nonconformities . 10
4.10 Korektivni ukrepi . 11 4.10 Corrective action . 11
4.11 Preventivni ukrepi . 12 4.11 Preventive action . 12
4.12 Nenehno izboljševanje . 12 4.12 Continual improvement . 12
4.13 Zapisi o kakovosti in strokovni zapisi . 12 4.13 Quality and technical records . 12
4.14 Notranje presoje . 13 4.14 Internal audits . 13
4.15 Vodstveni pregled . 13 4.15 Management review . 13
5 Tehnične zahteve . 14 5 Technical requirements . 14
5.1 Osebje . 14 5.1 Personnel . 14
5.2 Prostori in okoljske razmere . 15 5.2 Accommodation and environmental
conditions . 15
5.3 Oprema . 16 5.3 Equipment . 16
5.4 Predpreiskovalni postopki . 16 5.4 Pre-examination procedures . 16
5.5 Preiskovalni postopki . 17 5.5 Examination procedures . 17
5.6 Zagotavljanje kakovosti preiskovalnih 5.6 Assuring the quality of examination
postopkov . 17 procedures . 17
5.7 Popreiskovalni postopki . 18 5.7 Post-examination procedure . 18
5.8 Poročanje o rezultatih . 19 5.8 Reporting of results . 19
Literatura . 20 Bibliography . 20
SIST EN ISO 22870 : 2017
Evropski predgovor European foreword
Ta dokument (EN ISO 22870:2016) je pripravil This document (EN ISO 22870:2016) has been
tehnični odbor ISO/TC 212 "Preskušanje kliničnih prepared by Technical Committee ISO/TC 212
laboratorijev ter diagnostični sistemi in vitro" v "Clinical laboratory testing and in vitro diagnostic
sodelovanju s tehničnim odborom CEN/TC 140 test systems" in collaboration with Technical
"Diagnostični medicinski pripomočki in vitro", Committee CEN/TC 140 "In vitro diagnostic
katerega sekretariat vodi DIN. medical devices" the secretariat of which is held
by DIN.
Ta evropski standard mora dobiti status This European Standard shall be given the status
nacionalnega standarda bodisi z objavo of a national standard, either by publication of an
istovetnega besedila ali z razglasitvijo najpozneje identical text or by endorsement, at the latest by
maja 2017, nasprotujoče nacionalne standarde May 2017, and conflicting national standards shall
pa je treba razveljaviti najpozneje novembra be withdrawn at the latest by November 2019.
2019.
Opozoriti je treba na možnost, da je lahko nekaj Attention is drawn to the possibility that some of
elementov tega dokumenta predmet patentnih the elements of this document may be the subject
pravic. CEN (in/ali CENELEC) ne prevzema of patent rights. CEN [and/or CENELEC] shall not
odgovornosti za identifikacijo posameznih ali be held responsible for identifying any or all such
vseh takih patentnih pravic. patent rights.
Ta dokument nadomešča EN ISO 22870:2006. This document supersedes EN ISO 22870:2006.
Ta dokument je bil pripravljen v okviru mandata, This document has been prepared under a
ki sta ga Evropska komisija in Evropsko združenje mandate given to CEN by the European
za prosto trgovino dodelila CEN, ter podpira Commission and the European Free Trade
bistvene zahteve Uredbe (ES) 765/2008. Association, and supports essential requirements
of EC Regulation 765/2008.
V skladu z notranjimi predpisi CEN-CENELEC According to the CEN-CENELEC Internal
morajo ta evropski standard obvezno uvesti Regulations, the national standards organizations
nacionalne organizacije za standardizacijo of the following countries are bound to implement
naslednjih držav: Avstrije, Belgije, Bolgarije, this European Standard: Austria, Belgium,
Cipra, Češke republike, Danske, Estonije, Finske, Bulgaria, Croatia, Cyprus, Czech Republic,
Francije, Grčije, Hrvaške, Irske, Islandije, Italije, Denmark, Estonia, Finland, Former Yugoslav
Latvije, Litve, Luksemburga, Madžarske, Malte, Republic of Macedonia, France, Germany,
Nekdanje jugoslovanske republike Makedonije, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Nemčije, Nizozemske, Norveške, Poljske, Lithuania, Luxembourg, Malta, Netherlands,
Portugalske, Romunije, Slovaške, Slovenije, Norway, Poland, Portugal, Romania, Slovakia,
Španije, Švedske, Švice, Turčije in Združenega Slovenia, Spain, Sweden, Switzerland, Turkey
kraljestva. and the United Kingdom.
Razglasitvena objava Endorsement notice
Besedilo standarda ISO 22870:2016 je CEN The text of ISO 22870:2016 has been approved
odobril brez sprememb kot evropski standard EN by CEN as EN ISO 22870:2016 without any
ISO 22870:2016. modification.
SIST EN ISO 22870 : 2017
Predgovor Foreword
ISO (Mednarodna organizacija za ISO (the International Organization for
standardizacijo) je svetovna zveza nacionalnih Standardization) is a worldwide federation of
organov za standarde (članov ISO). Mednarodne national standards bodies (ISO member bodies).
standarde ponavadi pripravljajo tehnični odbori The work of preparing International Standards is
ISO. Vsak član, ki želi delovati na določenem normally carried out through ISO technical
področju, za katero je bil ustanovljen tehnični committees. Each member body interested in a
odbor, ima pravico biti zastopan v tem odboru. Pri subject for which a technical committee has been
delu sodelujejo tudi mednarodne vladne in established has the right to be represented on that
nevladne organizacije, povezane z ISO. V vseh committee. International organizations,
zadevah, ki so povezane s standardizacijo na governmental and non-governmental, in liaison
področju elektrotehnike, ISO tesno sodeluje z with ISO, also take part in the work. ISO
Mednarodno elektrotehniško komisijo (IEC). collaborates closely with the International
Electrotechnical Commission (IEC) on all matters
of electrotechnical standardization.
Postopki, uporabljeni pri pripravi tega The procedures used to develop this document
dokumenta, in predvideni postopki za njegovo and those intended for its further maintenance are
vzdrževanje so opisani v Direktivah ISO/IEC, 1. described in the ISO/IEC Directives, Part 1. In
del. Posebna pozornost naj se nameni različnim particular the different approval criteria needed for
kriterijem odobritve, potrebnim za različne vrste the different types of ISO documents should be
dokumentov ISO. Ta dokument je bil pripravljen noted. This document was drafted in accordance
v skladu z uredniškimi pravili Direktiv ISO/IEC, 2. with the editorial rules of the ISO/IEC Directives,
del (glej www.iso.org/directives). Part 2 (see www.iso.org/directives).
Opozoriti je treba na možnost, da je lahko nekaj Attention
...
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