1、BRITISH STANDARD BS EN 14254:2004 In vitro diagnostic medical devices Single-use receptacles for the collection of specimens, other than blood, from humans The European Standard EN 14254:2004 has the status of a British Standard ICS 11.100 BS EN 14254:2004 This British Standard was published under t
2、he authority of the Standards Policy and Strategy Committee on 06 July 2004 BSI 6 July 2004 ISBN 0 580 44020 6 National foreword This British Standard is the official English language version of EN 14254:2004. The UK participation in its preparation was entrusted to Technical Committee CH/212, IVDs,
3、 which has the responsibility to: A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue under the
4、section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct applicatio
5、n. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor
6、 related international and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 18, an inside back cover and a back cover. The BSI copyright notice displayed in this document indicates when t
7、he document was last issued. Amendments issued since publication Amd. No. Date CommentsEUROPEANSTANDARD NORMEEUROPENNE EUROPISCHENORM EN14254 June2004 ICS11.100 Englishversion InvitrodiagnosticmedicaldevicesSingleusereceptaclesfor thecollectionofspecimens,otherthanblood,fromhumans Dispositifsmdicaux
8、dediagnosticinvitroRcipients usageuniquepourprlvementhumainsnonsanguins InvitroDiagnostikaEinmalgefefrUntersuchungsgut vomMenschenmitAusnahmevonBlutproben ThisEuropeanStandardwasapprovedbyCENon23April2004. CENmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforg
9、ivingthisEurope an Standardthestatusofanationalstandardwithoutanyalteration.Uptodatelistsandbibliographicalreferencesconcernings uchnational standardsmaybeobtainedonapplicationtotheCentralSecretariatortoanyCENmember. ThisEuropeanStandardexistsinthreeofficialversions(English,French,German).Aversionin
10、anyotherlanguagemadebytra nslation undertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheCentralSecretariathasthesamestatusast heofficial versions. CENmembersarethenationalstandardsbodiesofAustria,Belgium,Cyprus,CzechRepublic,Denmark,Estonia,Finland,France, Germany,Greece,Hungary,Icela
11、nd,Ireland,Italy,Latvia,Lithuania,Luxembourg,Malta,Netherlands,Norway,Poland,Portugal, Slovakia, Slovenia,Spain,Sweden,SwitzerlandandUnitedKingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG ManagementCentre:ruedeStassart,36B1050Brussels 2004CEN Allri
12、ghtsofexploitationinanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.EN14254:2004:EEN 14254:2004 (E) 2 Contents Foreword3 1 Scope4 2 Normative references4 3 Terms and definitions .4 4 Materials.6 5 Nominal liquid capacity.6 6 Graduation and fill lines7 6.1 Graduation lines.7 6.2 M
13、inimum fill line.7 6.3 Maximum fill line7 7 Design.7 8 Construction.7 9 Sterility and special microbiological states8 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 recep
14、tacles up to and including 30 ml nominal capacity10 A.1 Reagents and apparatus.10 A.2 Test Conditions10 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 capacity11 B.1 R
15、eagents and apparatus.11 B.2 Test conditions11 B.3 Test procedures.11 Annex C (normative) Tests for draw volume and minimum free space for evacuated receptacles12 C.1 Reagents and apparatus.12 C.2 Test conditions12 C.3 Test procedure.12 Annex D (normative) Test for leakage from the closure of a rece
16、ptacle13 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 robust
17、ness of a receptacle that is intended for centrifugation 15 E.1 Reagents and apparatus.15 E.2 Test conditions15 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 For
18、eword 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 endorsemen
19、t, 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 Directiv
20、e(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 Eu
21、ropean 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 14254:20
22、04 (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 v
23、itro 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 bein
24、g 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
25、 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 revision
26、s 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 metho
27、ds (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
28、 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
29、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 compo
30、nent 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 h
31、older 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 recep
32、tacle 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 perf
33、ormed 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 provid
34、ed 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
35、 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 wh
36、ich 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
37、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
38、 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 weigh
39、ing 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 int
40、ended 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 analyt
41、ical 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 receptacles specifically intended use is the responsibility of the manufacturer. NOTE 1 This standard does n
42、ot 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 cl
43、ear 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
44、 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
45、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
46、 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
47、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 recept
48、acles 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, wi
