Single-use containers for human venous blood specimen collection

This document specifies requirements and test methods for single-use receptacles, intended by their manufacturer, for the collection of venous blood specimens derived from the human body, for the purposes of in vitro diagnostic examination. This document also applies to receptacles containing media for blood culture.
This document does not specify requirements for capillary blood specimen receptacles or arterial blood specimen receptacles. This document does not specify requirements and test methods for single-use receptacles intended for the collection of specimens, other than blood.

Gefäße zur einmaligen Verwendung für die venöse Blutentnahme beim Menschen

Dieses Dokument legt Anforderungen an und Prüfungen für Gefäße zur einmaligen Verwendung fest, die von ihrem Hersteller zur Entnahme von Venenblut aus dem menschlichen Körper für eine in-vitro-diagnostische Untersuchung bestimmt sind. Dieses Dokument gilt auch für Gefäße, die Nährmedien für Blutkulturen enthalten.
Dieses Dokument legt keine Anforderungen an Gefäße zur Blutentnahme aus Kapillaren oder Arterien fest. Sie legt auch keine Anforderungen an und Prüfverfahren für Gefäße zur einmaligen Verwendung fest, die zur Aufnahme anderer Proben als Blut bestimmt sind.

Récipients à usage unique pour prélèvements de sang veineux humain

La présente norme spécifie les exigences et méthodes d'essai relatives aux récipients à usage unique destinés par le fabricant aux prélèvements de sang veineux humain dans le but d'examens diagnostiques in vitro. La présente norme s'applique également aux récipients contenant des milieux pour hémoculture.
La présente norme ne spécifie pas d'exigences relatives aux récipients d'échantillons sanguins capillaires, ni aux récipients d'échantillons sanguins artériels. La présente norme ne spécifie pas d'exigences ni de méthodes d'essai relatives aux récipients à usage unique prévus pour le prélèvement d'échantillons autres que le sang.

Kontejnerji (epruvete s podtlakom) za zbiranje venske krvi ob enkratni uporabi

General Information

Status
Withdrawn
Publication Date
31-Aug-2004
Withdrawal Date
05-Sep-2017
Current Stage
9960 - Withdrawal effective - Withdrawal
Completion Date
06-Sep-2017

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Standard
EN 14820:2005
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Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Single-use containers for human venous blood specimen collectionKontejnerji (epruvete s podtlakom) za zbiranje venske krvi ob enkratni uporabiRécipients a usage unique pour prélevements de sang veineux humainGefäße zur einmaligen Verwendung für die venöse Blutentnahme beim MenschenTa slovenski standard je istoveten z:EN 14820:2004SIST EN 14820:2005en11.040.20Transfuzijska, infuzijska in injekcijska opremaTransfusion, infusion and injection equipmentICS:SLOVENSKI
STANDARDSIST EN 14820:200501-marec-2005







EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 14820September 2004ICS 11.040.20 English versionSingle-use containers for human venous blood specimencollectionRécipients à usage unique pour prélèvements de sangveineux humainGefäße zur einmaligen Verwendung für die venöseBlutentnahme beim MenschenThis European Standard was approved by CEN on 27 May 2004.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the Central Secretariat or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the officialversions.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, Slovakia,Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2004 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 14820:2004: E



EN 14820:2004 (E) 2 Contents Page Foreword.3 Introduction.4 1 Scope.5 2 Normative references.5 3 Terms and definitions.5 4 Materials.7 5 Nominal liquid capacity.8 6 Graduation and fill lines.8 7 Design.8 8 Construction.8 9 Sterility and special microbiological states.9 10 Additives.9 11 Information supplied by the manufacturer.9 12 Receptacle and additive identification.10 Annex A (normative)
Test for nominal liquid capacity and graduation marks, for non-evacuated blood specimen receptacles.12 A.1 Reagents and apparatus.12 A.2 Test conditions.12 A.3 Test procedure.
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