EN 14254:2004

In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans

This standard specifies requirements and test methods for single-use evacuated and non evacuated receptacles, intended by their manufacturers, for the primary containment and preservation of specimens, other than blood specimens, derived from the human body, for the purposes of in vitro diagnostic examination.
NOTE 1   Requirements and test methods for evacuated and non evacuated single use venous blood specimen containers are specified in prEN 14820.
NOTE 2   While it is desirable that specimen receptacles should be designed to avoid spontaneous discharge of the contents, when being opened, this standard does not specify a test procedure for this because it has not been possible to devise an objective and reproducible test.
This standard does not specify requirements for collection needles or needle holders or other accessories used in conjunction with specimen receptacles.

In-vitro-Diagnostika - Einmalgefäße für Untersuchungsgut vom Menschen mit Ausnahme von Blutproben

Diese Europäische Norm legt sowohl zusätzliche Anforderungen an die chemische Zusammensetzung von Aluminium und Aluminiumlegierungen fest, die für die Herstellung von Verpackungen und Verpackungskomponenten vorgesehen sind, als auch besondere Technische Lieferbedingungen. Der Anwendungsbereich dieser Norm wird vollständig durch die Endverwendung festgelegt.
ANMERKUNG   Einige in der vorliegenden Norm aufgeführte Produkte können Gegenstand von einem Patent oder Patentanmeldungen sein. Ihre Auflistung in dieser Norm bedeutet aber keinesfalls, dass dadurch eine Lizenzübertragung unter diesem Patentrecht erfolgt.
CEN/TC 132 bekräftigt seine Vorgehensweise, dass in dem Fall, wenn ein Patentinhaber sich weigert, für genormte Produkte Lizenzen unter angemessenen und nicht diskriminierenden Bedingungen zu erteilen, dieses Produkt aus der entsprechenden Norm zu entfernen ist.

Dispositifs médicaux de diagnostic in vitro - Récipients à usage unique pour prélèvement humains non sanguins

Cette Norme européenne spécifie les exigences complémentaires sur la composition chimique des produits destinés à la fabrication des emballages et des composants d'emballage, ainsi que les conditions techniques de contrôle et de livraison particulières qui s'y appliquent. Le domaine d'application de cette norme est complètement défini par la destination finale du produit, et par le fait que le produit est réalisé en aluminium ou alliage d'aluminium.
NOTE   Des produits cités dans la présente norme peuvent faire l'objet de brevet ou de demandes de brevets, et leur inclusion dans la présente norme ne doit être en aucune façon considérée comme l'attribution d'une licence au regard des droits attachés à de tels brevets.
Le CEN/TC 132 confirme que dans le cas où le détenteur d'un brevet refuse de céder des licences sur les produits normalisés sous des conditions raisonnables et non discriminatoires, alors ce produit serait éliminé de la norme correspondante.

Diagnostični medicinski pripomočki in vitro – Posode za zbiranje vzorcev človeškega tkiva in drugih vzorcev, razen krvi, za enkratno uporabo

General Information

• Status: Withdrawn
• Publication Date: 29-Jun-2004
• Withdrawal Date: 07-Sep-2021
• ICS: 11.100 - Laboratory medicine
• Technical Committee: CEN/TC 140 - In vitro diagnostic systems
• Drafting Committee: CEN/TC 140 - In vitro diagnostic systems
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 08-Sep-2021
• Directive: 98/79/EC - Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
• Mandate: M/252 - Standardization Mandate to CEN/CENELEC concerning the development of European standards relating to in vitro diagnostic medical devices
• Ref Project: SIST EN 14254:2005 - In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans

Relations

• Replaced By: EN ISO 6717:2021 - In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood (ISO 6717:2021)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humansY]RUFHYERDispositifs médicaux de diagnostic in vitro - Récipients a usage unique pour prélevement humains non sanguinsIn-vitro-Diagnostika - Einmalgefäße für Untersuchungsgut vom Menschen mit Ausnahme von BlutprobenTa slovenski standard je istoveten z:EN 14254:2004SIST EN 14254:2005en,fr,de11.100.10In vitro diagnostic test systemsICS:SLOVENSKI
STANDARDSIST EN 14254:200501-januar-2005







EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 14254June 2004ICS 11.100English versionIn vitro diagnostic medical devices - Single-use receptacles forthe collection of specimens, other than blood, from humansDispositifs médicaux de diagnostic in vitro - Récipients àusage unique pour prélèvement humains non sanguinsIn-vitro-Diagnostika - Einmalgefäße für Untersuchungsgutvom Menschen mit Ausnahme von BlutprobenThis European Standard was approved by CEN on 23 April 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 14254:2004: E



EN 14254:2004 (E) 2 Contents Foreword.3 1 Scope.4 2 Normative references.4 3 Terms and definitions.4 4 Materials.6 5 Nominal liquid capacity.6 6 Graduation and fill lines.7 6.1 Graduation lines.7 6.2 Minimum fill line.7 6.3 Maximum fill line.7 7 Design.7 8 Construction.7 9 Sterility and special microbiological states.8 10 Additives.8 11 Information supplied by the manufacturer.8 Annex A (normative)
Tests for nominal capacity, graduation lines and minimum free space for non-evacuated specimen receptacles up to and including 30 ml nominal capacity.10 A.1 Reagents
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