EN 14254:2004

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

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

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.

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

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.

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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