SIST EN 14820:2005
(Main)Single-use containers for human venous blood specimen collection
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 a usage unique pour prélevements de sang veineux humain
La présente norme spécifie les exigences et méthodes d'essai relatives aux récipients a usage unique destinés par le fabricant aux prélevements 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 a usage unique prévus pour le prélevement d'échantillons autres que le sang.
Kontejnerji (epruvete s podtlakom) za zbiranje venske krvi ob enkratni uporabi
General Information
Relations
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.12 Annex B (normative)
Tests for draw volume for evacuated receptacles.13 B.1 Reagents and apparatus.13 B.2 Test conditions.13 B.3 Test procedure.13 Annex C (normative)
Test for leakage from the closure of a receptacle.14 C.1 Reagents and apparatus.14 C.2 Test procedure for non-evacuated container.14 C.3 Test procedure for evacuated receptacles.14 Annex D (normative)
Test for the robustness of a receptacle that is intended for centrifugations.16 D.1 Reagents and apparatus.16 D.2 Test conditions.16 D.3 Test procedure.16 Annex ZA (informative)
Relationship between this
European
Standard and the Essential Requirements
of EU Directive 98/79/EC.17 Bibliography.19
EN 14820:2004 (E) 3 Foreword This document (EN 14820:2004) has been prepared by 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 March 2005, and conflicting national standards shall be withdrawn at the latest by March 2005. 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 EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document. 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, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EN 14820:2004 (E) 4 Introduction This document provides requirements relevant to specimen receptacles for venous blood. Revision of ISO 6710:1995 was proposed by a number of countries, mainly in Europe, due to technical changes made in the manufacture of these receptacles. A number of countries strongly require colour coding of receptacles for their perceived safety of patients. Two well-established colour codes are in common use. Furthermore, it is suggested that bespoke colour coding of these products is an increasing trend. Any changes by manufacturers increase the cost of production and as a consequence the price of receptacles to users. It has not therefore been possible to make any agreed international recommendations on colour codes of receptacles and so this document has been prepared without a recommended colour codes as the only possible means of obtaining consensus by Standards bodies.
EN 14820:2004 (E) 5 1 Scope 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. 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 (including any amendments) applies. EN 20594-1, Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements (ISO 594-1:1986) EN ISO 3696, Water for analytical laboratory use - Specification and test methods (ISO 3696:1987) 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 additive substance, other than surface treatments designed to be irremovable, that is placed inside the receptacle to facilitate the preservation of the specimen, or is intended to react with the specimen, in order to allow the intended analysis to be performed 3.2 blood collection system all the components required for the collection of a specimen of blood 3.3 closing torque twisting force, specified by the manufacturer, that is required to tighten a screw threaded closure sufficiently, by means of a torque wrench, to effect the sealing of a receptacle 3.4 closure component by which the container is closed 3.5 container part of the receptacle without the closure, and without any accessory, that contains the specimen NOTE Depending on the intended application, the part of the receptacle, without the closure, that contains a blood specimen may also be known as a "tube", "bottle", "vial" or similar name. 3.6 draw volume quantity of liquid specimen drawn into an evacuated receptacle
EN 14820:2004 (E) 6 3.7 evacuated receptacle receptacle intended for specimen collection by means of evacuation, either already induced by the manufacturer (i.e. pre-evacuated receptacle), or induced by the user immediately before a liquid specimen is taken 3.8 expiry date date after which the receptacle shall not be used 3.9 filling capacity volume of a liquid specimen needed to achieve the required additive to blood ratio 3.10 free space extra capacity, or headspace, which is provided to allow adequate mixing of the contents of a receptacle
3.11 graduation mark mark on a container, or its label, to enable an estimation to be made of the volume of the specimen 3.12 gravimetric analysis method of determining the volume of a liquid by weighing and correcting for the mass density of the liquid NOTE For the purposes of this document 1,000 ml of water is considered to have a mass equal to 1,000 g. 3.13 maximum fill line mark on a container or its label, to indicate the maximum volume of specimen permitted to ensure that the in vitro diagnostic test for which the specimen is intended, will give accurate results 3.14 minimum fill line mark on a container, or its label, to indicate the minimum volume of specimen required to ensure that the in vitro diagnostic test, for which the specimen is intended, will give accurate results 3.15 needle and holder assembly device that is intended to be attached to an evacuated receptacle to enable venous puncture and subsequent blood collection to be performed 3.16 nominal liquid capacity volume of specimen with which the receptacle is intended to be filled plus the volume of any additive NOTE This volume is stated on the label and/or instructions for use. 3.17 nominal fill line mark on a container, or its label, to indicate the nominal liquid capacity of a receptacle 3.18 primary pack smallest pack of receptacles
EN 14820:2004 (E) 7 3.19 receptacle vessel, whether evacuated or not, intended to contain a specimen, together with any receptacle accessory and additive, with closure in place 3.20 receptacle accessory component inside the receptacle which is intended by the manufacturer to assist in the collection, or mixing, or separation, of the specimen NOTE Examples of receptacle accessories are small plastic inert balls or a separate gel found in a serum or plasma receptacle, designed to separate the serum or plasma from the cells after centrifugation. 3.21 receptacle interior inside surface of the receptacle or closure and the surface of any receptacle accessory exposed to the specimen 3.22 specimen biological material (e.g. venous blood) which is obtained in order to detect properties or to measure one or more properties 3.23 visual inspection inspection by an observer with normal, or corrected-to-normal, vision without magnification, under a uniform illumination in the range from 300 lx to 750 lx
4 Materials 4.1 If a receptacle is intended to contain a specimen for a specific examination, where the material of the closure, or container, or the interior coating, or the additive, or accessory, if present, may affect the final results of the examination, then the maximum level of the contamination with that substance, and the analytical method employed, shall be stated by the manufacturer in accompanying literature, or on the label, or packaging (see also 11.3). Validation of the suitability of material with regard to a receptacle's specifically intended use is the responsibility of the manufacturer. NOTE 1 This document does not specify a validation procedure for material suitability. NOTE 2 For certain infrequently performed examinations, limits of interference may not have been determined and the user is recommended to consult the manufacturer. NOTE 3 A container should be manufactured from a material which allows a clear view of its contents when subjected to visual inspection (see 3.22) unless exposure to ultra-violet light, or visible light would degrade the contents. NOTE 4 If the container is not made of material that allows a clear view of the contents, the closure may be removed, to facilitate the examination of the contents. 4.2 When subjected to visual inspection the material of the receptacle shall be free from foreign matter. 4.3 Receptacles containing a microbe-supporting additive shall have been subjected to a validated process to eliminate microbial contamination from the additive and the receptacle interior. Validation of the process is the responsibility of the manufacturer.
NOTE For the validation and routine control of sterilization procedures see EN 550, EN 552 and EN 554.
EN 14820:2004 (E) 8 5 Nominal liquid capacity 5.1 When tested in accordance with the methods specified in either Annex A or B, the volume of water added from, or drawn from, the burette, plus the volume of any additive present, shall be between 90% and 110 % of the nominal capacity. 5.2 For receptacles with an additive, provision shall be made for mixing by using the free space bubble to facilitate agitation, or by some other physical means.
5.3 Where free space is intended to facilitate mixing there shall be sufficient free space to allow mixing by mechanical or manual means. 5.4 The manufacturer shall validate that adequate mixing of the blood specimen, with any additive present, can be achieved. NOTE This document does not specify a validation procedure for adequate mixing of the blood specimen. 6 Graduation and fill lines Evacuated receptacles that have a fill line on the container, or container label, shall fill such that the meniscus of the liquid does not exceed or fall below the position of the line by more than 10% when tested in accordance with the method specified in Annex B. When non-evacuated receptacles that have graduation marks are tested in accordance with methods specified in Annex A, the volume of the water shall be between 90% and 110% of the indicated volume. NOTE see Annex A, A.3.6 7 Design 7.1 The closure shall not become loose when tested for leakage in accordance with the method specified in Annex C. The receptacle shall pass the test for leakage if no fluorescence is observed. 7.2 Where a closure is intended to be removed, to gain access to the contents of the receptacle, it shall be designed, as far as is reasonable and practical to do, so that it can be removed by gripping with the fingers, and/or by mechanical means, without that part of the closure which may become contaminated by contact with the specimen, being touched by the fingers, or the mechanical removal device. NOTE It is desirable that specimen receptacles should be designed to avoid spontaneous discharge of the contents, when being opened. This document does not specify a test procedure for this because it has not been possible to devise an objective and reproducible test. 7.3 When the receptacle is tested for leakage in accordance with the method specified in Annex C, no fluorescence shall be detectable in the water in which the receptacle has been immersed. 8 Construction 8.1 Receptacles shall withstand 4 cycles of removal and replacement of the closure in accordance with
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