EN 14820-2004 en Single-use containers for human venous blood specimen collection《人类静脉血样品采集用一次性容器》.pdf

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1、BRITISH STANDARD BS EN 14820:2004 Single-use containers for human venous blood specimen collection The European Standard EN 14820:2004 has the status of a British Standard ICS 11.040.20 BS EN 14820:2004 This British Standard was published under the authority of the Standards Policy and Strategy Comm

2、ittee on 8 September 2004 BSI 8 September 2004 ISBN 0 580 44421 X National foreword This British Standard is the official English language version of EN 14820:2004. It supersedes BS ISO 6710:1995 which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee CH/212,

3、 IVDs, 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 unde

4、r the 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 appl

5、ication. 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; m

6、onitor 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 19 and a back cover. The BSI copyright notice displayed in this document indicates when the document was

7、last issued. Amendments issued since publication Amd. No. Date CommentsEUROPEANSTANDARD NORMEEUROPENNE EUROPISCHENORM EN14820 September2004 ICS11.040.20 Englishversion Singleusecontainersforhumanvenousbloodspecimen collection Rcipientsusageuniquepourprlvementsdesang veineuxhumain GefezureinmaligenVe

8、rwendungfrdievense BlutentnahmebeimMenschen ThisEuropeanStandardwasapprovedbyCENon27May2004. CENmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEurope an Standardthestatusofanationalstandardwithoutanyalteration.Uptodatelistsandbibliographicalrefere

9、ncesconcernings uchnational standardsmaybeobtainedonapplicationtotheCentralSecretariatortoanyCENmember. ThisEuropeanStandardexistsinthreeofficialversions(English,French,German).Aversioninanyotherlanguagemadebytra nslation undertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheCentralSec

10、retariathasthesamestatusast heofficial versions. CENmembersarethenationalstandardsbodiesofAustria,Belgium,Cyprus,CzechRepublic,Denmark,Estonia,Finland,France, Germany,Greece,Hungary,Iceland,Ireland,Italy,Latvia,Lithuania,Luxembourg,Malta,Netherlands,Norway,Poland,Portugal, Slovakia, Slovenia,Spain,S

11、weden,SwitzerlandandUnitedKingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG ManagementCentre:ruedeStassart,36B1050Brussels 2004CEN Allrightsofexploitationinanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.EN14820:2004:EEN 14820:20

12、04 (E) 2 Contents Page Foreword3 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 lines8 7 Design .8 8 Construction.8 9 Sterility and special microbiological states9 10 Additives.9 11 Information supplied b

13、y 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

14、 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 evacuate

15、d 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 D

16、irective 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

17、, 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 Associat

18、ion, 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 im

19、plement 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 Kingd

20、om. 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

21、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 an

22、d 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 Stan

23、dards 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 als

24、o 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 collectio

25、n 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) a

26、pplies. 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 purp

27、oses 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 in

28、tended 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 effec

29、t 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 conta

30、ins 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

31、 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 fr

32、ee 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 l

33、iquid 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

34、 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 r

35、esults 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

36、 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 evacuate

37、d 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

38、 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 accessor

39、y 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 ill

40、umination 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 examinat

41、ion, 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 receptacles specifically

42、 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 manuf

43、acturer. 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

44、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 v

45、alidated 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 Nomin

46、al 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, provi

47、sion 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 ad

48、equate 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 Anne