SIST EN 14254:2005

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 and apparatus.10 A.2 Test Conditions.10 A.3 Test procedure.10 Annex B (normative)
Tests for nominal capacity, graduation lines and minimum free space, for non-evacuated specimen receptacles of greater than 30 ml nominal capacity.11 B.1 Reagents and apparatus.11 B.2 Test conditions.11 B.3 Test procedures.11 Annex C (normative)
Tests for draw volume and minimum free space for evacuated receptacles.12 C.1 Reagents and apparatus.12 C.2 Test conditions.12 C.3 Test procedure.12 Annex D (normative)
Test for leakage from the closure of a receptacle.13 D.1 Reagents and apparatus.13 D.2 Test procedure for non-evacuated receptacles intended for storage above 0 °C.13 D.3 Test procedure for non-evacuated receptacles intended for storage at 0 °C or below.13 D.4 Test procedure for evacuated receptacles.14 Annex E (normative)
Test for the robustness of a receptacle that is intended for centrifugation.15 E.1 Reagents and apparatus.15 E.2 Test conditions.15 E.3 Test procedure.15 Annex ZA (informative)
Relationship between this
European
Standard and the Essential Requirements
of EU Directive 98/79/EC.16 Bibliography.18



EN 14254:2004 (E) 3 Foreword This document (EN 14254:2004) 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 December 2004, and conflicting national standards shall be withdrawn at the latest by December 2004. 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. Annexes A, B, C, D and E are normative. 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 14254:2004 (E) 4 1 Scope 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 EN 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. 2 Normative references This European Standard incorporates by dated or undated reference provisions from other publications. These normative references are cited at the appropriate places in the text and the publications are listed hereafter. For dated references, subsequent amendments to or revisions of any of these publications apply to this European Standard only when incorporated in it by amendment or revision. For undated references the latest edition of the publication referred to applies (including amendments). EN ISO 3696, Water for analytical laboratory use — Specification and test methods (ISO 3696:1987) ISO 4788, Laboratory glassware — Graduated measuring cylinders 3 Terms and definitions For the purposes of this European Standard, the following terms and definitions apply. 3.1 receptacle vessel, whether evacuated or not, intended to contain a specimen, together with any receptacle accessory and additive, with closure in place 3.2 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 3.3 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 specimen, may also be known as a “tube”, “bottle”, “vial”, or similar name. 3.4 closure component by which the container is closed 3.5 receptacle accessory component inside the receptacle which
is intended by the manufacturer to assist in the collection or mixing, or separation, of the specimen EXAMPLE
Sampling spoons intended for the collection of solid specimens.



EN 14254:2004 (E) 5 3.6 holder and suction tip assembly device that is intended to be attached to an evacuated receptacle to enable liquid sample collection to be performed 3.7 primary pack smallest pack of receptacles 3.8 receptacle interior inside surface of the container receptacle or closure and the surface of any receptacle accessory exposed to the specimen 3.9 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 EXAMPLE
Solid culture media. 3.10 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 the instructions for use. 3.11 free space extra capacity, or headspace, which is provided to allow adequate mixing of the contents of a receptacle NOTE This volume is determined by the minimum free space tests described in annexes A, B and C. 3.12 nominal fill line mark on a container, or its label, to indicate the nominal liquid capacity of a container. NOTE A container can be marked with more than one fill line. 3.13 filling capacity volume of a liquid specimen needed to achieve the required additive to specimen ratio 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, can give accurate results 3.15 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, can give accurate results 3.16
graduation line mark on a container, or its label, to enable an estimate of the volume of a liquid specimen
NOTE A container can be marked by more than one graduation line. 3.17 draw volume quantity of liquid specimen drawn into an evacuated receptacle



EN 14254:2004 (E) 6 3.18
expiry date date after which the receptacle shall not be used 3.19 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 3.20 gravimetric analysis method of determining the volume of a liquid by weighing and correcting for the mass density of the liquid 3.21 volumetric analysis method of determining the volume of a liquid by using a burette 3.22 specimen biological material which is obtained in order to detect properties or to measure one or more quantities 4 Materials 4.1 If a receptacle is intended to collect 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 11.7). Validation of the suitability of material with regard to a receptacle's specifically intended use is the responsibility of the manufacturer. NOTE 1 This standard 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 the contents when subjected to visual inspection by an observer with normal, or corrected-to-normal, vision without magnification, under a uniform illumination between 300 lx and 750 lx unless exposure to UV 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. 5 Nominal liquid capacity 5.1 For non-evacuated receptacles with a nominal liquid capacity up to and including 30 ml, and all evacuated receptacles, when tested in accordance with the methods specified in either annex A or C, the volume of water added plus the volume of any additive present shall be within ± 10 % of the nominal capacity. 5.2 For non-evacuated receptacles with a nominal liquid capacity greater than 30 ml, the volume of water added shall be within ± 10 % of the nominal capacity when tested as specified in annex B.



EN 14254:2004 (E) 7 5.3 For receptacles with an additive or for receptacles intended for the collection of liquid suspensions that may settle out upon standing, provision shall be made for mixing. Where free space is intended to facilitate mixing there shall be sufficient free space to allow mixing by mechanical or manual means when tested in accordance with annexes A, B and C. Validation of claims for the adequacy of mixing is the responsibility of the manufacturer. NOTE This standard does not specify a validation procedure. 6 Graduation and fill lines 6.1 Graduation lines When non-evacuated receptacles, of any capacity, with graduation lines are tested in accordance with the methods specified in either annex A or B, the volume of water shall be from 90 % to 110 % of the volume indicated by the graduation lines. 6.2 Minimum fill line Evacuated receptacles that have a minimum fill line on the container, or container label, shall fill such that the meniscus of the liquid reaches, or exceeds, the position of the line when tested in accordance with the method specified in annex C. 6.3 Maximum fill line Evacuated receptacles that have a maximum fill line on the container, or container label, shall fill such that the meniscus of the liquid reaches but not exceeds the position of the line when tested in accordance with the method specified in annex C. 7 Design 7.1 The closure shall not become loose when tested for leakage in accordance with the method specified in annex D. The receptacle shall pass the test for leakage if no fluorescence is observed. NOTE This standard does not specify a test procedure for receptacles intended by the manufacturer for storage in liquid nitrogen. 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 reasonably and practical to do, so that it can be removed by gripping with the fingers, and/or 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. 7.3 Visibility of the specimen shall not be completely obscured by any label, print or mark. 7.4 The unused and dry label shall be suitable for marking with a writing implement as specified by the manufacturer. 7.5 The marking and the label on the receptacle shall remain adherent and legible after exposure in air at (4 ± 1) °C for not less than 72 h. 7.6 If the manufacturer claims that the receptacle is suitable for storage at temperatures outside the normal ambient range, the label, the adhesive if used and marking shall remain in place, in a dry state, and be legible at the extremes of the temperature range, specified by the manufacturer, for a minimum of 72 h at each stated extreme. 8 Construction 8.1 Receptacles shall withstand 4 cycles of removal and replacement of the closure in accordance with the manufacturers instructions, without breaks, collapse, cracks, or other visible damage, and when tested according to



EN 14254:2004 (E) 8 the annexes A, B, C and D. Where the initial opening of the receptacle destroys the closure, these requirements shall apply to the subsequent closure. NOTE
It has proved difficult to specify a single test procedure for robustness. The requirements specified above are intended to simulate the mechanical stress that occurs during the normal filling of the receptacle, storage, transportation and removal of the sample. Requirements for the transport of the specimen, in the receptacle, are given in UN 602 [11] and UN 650 [12]. 8.2 Receptacles intended for centrifugation shall withstand a minimum acceleration of 3 00
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