His International: Standard. specifies. requirements testimothods for evacuated and’ norrevecuated 8 Venous blood’ specimen containers. ‘hot specify requirernents’ fot blbéd = OF néedie elders. ‘This International Standard replaces the require ‘on-evecuated containers previously #22, Single. use. blood specimen. containers up to ‘capac, which has been withdrawn, ‘The following Standards contain: provisions: which ‘through reference in this text, constitute: provisions cf this International ‘Standard. At the time of publk “cation, the editions indicated ware valid All standards: ‘fe. subject to revision, and parties’ to agreoments based on this Intemnstional Staridard ere encoureged ‘o investigate th possibilty of applying the most re- Cent editions of the: standards incicated below. Menibérs’ of 1EC and ISO msintain registers of cur tently valid International Standards, | 150.891-1:1006, Conical ftngwth a 6 96 (Len te "ger for syringes, needles and certain other medical | Squpment — Part 1: General requirements, + 150 369611307, Water for anaiytical inboratory uso — " Scecificetion and test methods: © #30 7000:1989, Graphical symbéis for use’ on ‘equip- = Index and synopsis. Purposes of this Internationel Standard, the: ving definitions apply. 3.1. container: Vessel to contain a blood specimen, with closure in place: 3.2 evacuated container: Container intended for blood collection by means of evacuation either already induced by the manufacturer (Le, pre-evacusted con teiners} oF induced by the user before blood is taken, 3:3: tube: That part of the container, without the closure, that contains the specimen. ‘314 * closure: Cortponent by: which the conitalhbr ts closed, 3.5 primary pack: Smallest package of containers, 3.6 container interior: Inside surface of the con- tainer, 3.7 additive: Any ‘substanios (other than inside sur face treatments desigried to be imemovable) that is Placed in the container in order to ellow the intended analysis to be performed. 3.8 nominal capacity: Volume of whole blood with ‘which the contsiner is intended to be filled. 3.9. free space: Extra capacity, or head space, which is provided to allow adequate mixing of the contents ofa container, as determined by. the minimum free space tests laid down in annexes And 8. 3.10 fill line: Line marked on @ tube or its label to indicate the:nominal capacity of a container. ‘3.11. ‘draw volume: Nominal capacity of an evacu- ‘ted container, 3.12. expiry date: Deto after which the manufac turer does not claim that a container complies with the requirements of this International Standard.180 6710:1995(E) 3.13 closing torque: Twisting force, specified by the manufacturer, that is required to tighten a closure sufficiently by means of a torque wrench to effect the sealing of a container, 3.14 visual inspection: inspection by en observer with normal: or corrected-tonermal vision without ™egnificetion under @ uniform illuminance: between $300 bk end 750 be. i 4 Materials 4.1 The tube shall be made of material which allows 4 clear view of the contents when subjected to visual inspection. {t is recommended that the ‘inner surfaces of glass tubes intended to receive ‘specimens for blood co- agulation studies should not allow contact activation (see [1]). 4:2 If a container is intended specifically for the de- ‘termination ofa certain substance, the maximiurn level of container interior contamination with that sub-— ‘stance and the analytical method employed shall be stated by the manufacturer in accompanying literature ‘8F on the label or packaging (see also 10.4), For the determination of specified metals and other ‘specified substences, the formulstion of the closure ‘material should be suchas not to interfere with the determination thereby affecting the results, NOTE2 For highly sensitive determinations (for exemple those using fluorimetry) of litlecised tests, limits of inter- ‘ference may not have been agreed on. In such cases the User is recommended to consult the manufacturer. 4.3 Containats "with ‘mierobe-supporting: additives Suich as. trisodium citrate of citrate. phosphate: dextrose adenine solution shall have been ‘subjected 10 a validated process to’ eliminate microbial ‘contami nation from the additive and the container interior, NOTES Validation of the process Is thé responsibilty-of the misnufecturer. This Intemational. Standard does. not ‘Spétify 4: validation: procedure but international Standords ‘on this subject are being prepared. 4,4 The container: shall be'free fromforeign matter when subjected to visual inspection. ~e1s¢ 5 Capacity 5.1 When tested in accordance with’ the methods Specified in annexes-A and B, the volume of water added from or drawn from the burette shall be within £10 % of the nominal capacity: 8.2 . For containers with aft additive, there shall bs sufficient free-space, when tested’ in accordance with, ths methods specified in'annexes.A and 8, to allow adequate mixing by mechanical or manual means. The minimutn free space shall be as'specified in table 1 “Allowance shall be tmade'tor the fact that the avellable- free space for mixing the contents of a container is bounded by ‘the: underside of the closure: and’ the Tiquid: meniscus. Table 1 — Minimum ffee space to enable adequate mixing 208 mi and'<6 mi 2omi 6 Design cs 8.1 The closure shall not become loose during mie ing when tasted for leakage in accordance’ with the methods specified in annex C. 6.2. Where. closure is intended to be removed to gain éccess'to the contents of the container, It shall bbe. designed 0: thet it cen te remaved by gripping with the fingers and/orby methenical means without that part of the closure which: thay be: contamineted by contact with the specimen: ‘being touched by the fingers. NOTE 4 Some instrumentationy-e.9. blood call. counters, {s designed to enable espiration of the contents of 3 blotd ‘specimen container without the: need to retove' the clos- ure, : : 8.3 When the conteiner is tested for leakage in ac- cordance with the method specified in annex C, no fluorescence shall be detectable inthe water in which the container has been immersed;The. container holding the’ specimen, when centtifuged, shall withstand an acceleration of 3 000g ina longitudinal axis when tested in accordance with the method specified in annex:D, NOTES ” 2, = 9,606 65 m/s? 7.2 When subjected 46 Vista! inspection, ‘the ‘com tainer Shall not‘have.a ‘sharp edge, ‘projection or sur- face roughness capable of accidentally cutting, Puneturing or abreding'the skin of the user. 8 Sterility 8.1 [fa manufacturer claims that & producti sterile, the’ container interior and any ‘contents shall have been subjected to @ validated process designed to. ‘ensure’ that theunopened and’ unused container Ine terior snd any contents of the ‘conteinet are sterile: NOTES. Validation of the etflcaey of the process & the esponsibility of the manufacturer. Tis intemelional Stare 8 4 Validation. procedure but Inter t methods of eontrating and validating _Stetlization processes’ ata. being prepared. In the absence. pf Intetetional Standards, its reeammerided that reference © Should:be made to eny national requirements that exist, : tional requifements exist, reference should be during: blood cor. ry wih Be y’ possibility of direct Contact ba i the ‘container interior*and the’ patient's blood Z paillth one exception se8 9.2) assay methods are fed Flea photometric essays are recommended “Contain sodium, potassium:or lithium. it i assays re carried out with an sccuracy =t9 with the limit of error implied in ennex €. If , lame photon m ahd potessiim salts of EDTA it is reo- er Keentiication test be cared out, 2 liquid additive: ita container ed gravimetrically with @ correction rthe specific gravity of the liquid, 10 ‘Marking ’and tabellin ‘10:1 “Labels shall not completely encircle the tubes. 10.2 The marking end labeling ‘on. the container shall temain “adherent after exposure in air at 421) °C fornotless than 48 h, : NOTES This: subclause ‘specifies. the sequement for . Products under normal conditions, However, when products: ‘te stored o Used under esaremie conditions (ag, extreme tefmipsrature or humidity, or abnormal ‘transportation of ‘storage for long patiods) the ‘requirement may be inad~ ‘equate, A manufacturer is responsibié for @ claim thet e product suitable! for storage or use under extrame or ab / Normal conditions. " 410.3. Each primary peck shell be Ibe on the ‘outside with the following information: 2) the manufacturer's or supp ira lame "“OF trade- ‘bY the batch number: “@) the expiry date; ‘| 2 description of the contents; which shall include — the nominal capacity, = all tube coatings (e.g, or additives, hon‘coitect activation) = the natne of any: additive: or its’ foribletion ‘andor the letter code as given in teble2, — the word “sterilo” it the meniifacturer cla that the unopened container interior and any Contents of the container ere stele, _— the Words “singletuse only" or the ‘graphical ‘symbol according to ISO 7000-1081, = storage requirements. 10.4 if'a container is provided speciticely for the determination of a certain: substance, the meximum {evel of contamination with that substance shel! be ‘stated on the label or the’ primary pack. 10.5 Containers shall have the folowing information marked directly onto'the tube Or on the label: 2)" the manufecturer’s or supplier's name or trade- mark; . b) the batct number;180 6710:1996(e) @ tthe letter code (seo: clouse = etintion of the contents 11) and/or a de- @) the exciry date; @) ‘then inal capacity: A a fil ine where necessary, Le., for non-avacuated Containers; 9) ‘the word “sterile” if the manufacturer claims that the unopened end unused container intetior and ‘any contants of the container are sterile. Hf glyoarol is used in the manufacture of a container, {his shculd be stated on the label and on the packeg- ing. 11 Container identification Containers shell be identifiod by means of tha letio ode and/or a description for the ‘adcitives civen teble 2. Where there are additives other then thoss table2, containers shall be identified by means ‘descrintion of the additive, NOTES 8 At present there is no international eqreoment on eclou coding 10 colour coding is also used, the colours in tabla? an recommended. 11. If colour coding is eiso used, it is recommended the the colour of the closure is similar to that on tha tugs cr bel. Table 2 — Letter codes and recommended calour codes for identifying additives Additive Letter code Recommended colour coda EDTAN dipotassium. K2E ‘Lavender | sat | tipotassium Kae Lavender | salt | dso sate Na Lavend | Tisodum cite a enc Ligh bue | Tisodium civste 4 anc Baek | Fleridvoxiae K Grey | Fluoride/EOTA, Fe Grey I Fucrderopacn fH Green Uthium heparin ur Green Seciurn heparin NH Green Ciretashosshate dextrose adoring PDA Yetow Nero) z es 1)_EDTA is the abbreviation for ethylenediaminetettat Correet systematic name, i. (ethylenedinitileletreacetic a Of cittsto solution). 3) tis -ecommended olour cove, together with a description of the sddtive. ie ecid which by established custom is used in proferenca to the id. 3 cxenats the fae between the intended volumes of bood and quid entiooaglent (6.9.8 veumes ot ocd fo yum | Ta despa With a blosdcleting accelerator may be coded withthe latter code 2 ant hove 3 cedAnnex A ~ (normative): Asa Pattee ihr ABA “Continue: cing ‘in water from the burette z until it is levet with the mouth of the tube end read , 50 mi capaci off the Volume’deliverad to an eéduracy of + 0,1 ml. pacity, (accurate to: ot 0,1 mah mh tap at the " AA Test criteria nditions A “The container shall pass the fominal capacity test if the volume ‘of water delivered is within sts ‘shall be “caitied but ih ambient. + 10 % of the nominal capacity. ‘A.A.2°° The ‘container shall pass the tinimiutn free oe if, after alowancs for theft that 18 availabl ee y for mixing the-contents of @ ntainer bby the underside of the closure and the: aie meniscus, the:available free space is fot less that thet specified in table for:the:type of container tested. ea ee eee ae oars blood contact side of ‘ay extend spprecsbly ‘measurement, of he plug par of to cosut, 6 of text valu Pro. vided by @ concave feature.1SO 6710:1995(E) B.1 Reagents and apparatus B, 25°C. ‘Water, complying witli ISO 3696, ot 20 “C10 B.1.2 Burette, 50 mi capacity, graduated in 0,1 ml jnerements (acourate to + 0,1 mi) with @ tap at the bottom or side, B.1.3Clear'éilicone rubber tubing (short length) fitted with a spring clip at-one end and attached to the burette tap at the other-end, B.1.4 Blood collection needles as recommended by the manufacturer of the specimen container. B:15 Holder-as recommended by the menufec- ‘turer-of the specimen container. B.2. Draw volume test B21. Test conditions B.2.1.1 The tests shall be carried out jn. amblent conditions of 101 KPa and 20 °C; make corrections. if other conditions are used. B.2.1.2 The container to be tested:shall be unused: B22 Test procedure readyassembled, and fit the blood collection needle {nto the holder in eccordancs with the manufacturer's: instructions. 8222 Fil the burette with the water, open the ‘burette tap and bleed through the spring clip to fil the silicone rubber tubing: 2er0 the burette, 8.2.23 Inseit the outer needle of the blood col, lection needlesholder assembly through the wall of the silicone tubing-until the needle is well inside the lumen of the silicone tubing, ‘Annex : {normative} 8.2.2.1 Assemble the: product, “it not supplied e180 ai Tests for draw volunie and minimum free space for evacuated contairiers + B22 Connect the container to the needleymolder assembly in accordance. with the manutecture's,n- ‘structions. . B.2.2.5 Allow the containet to fil for at'feast 1 min or fill as specified by the manufacturer. 8.226 Level the-mehiscus and Yéad‘offthe draw volume with:an ‘accuracy of + 0,1 mi by réference:to ‘the meniscus height in the burette.. B23 Test criteria BSAA Carry out the tests 101 kPa and 20°C; make cortections: if other con- ditions ere used. 2:12 The containers to’be tested shell be unused. B32. Test procedure 1.3.2.1 Remove the aileone tubing for tha delivery jet of the burette with the tepsciosed and top up the burette with the water as necessary. ='B322° Positions tube’ with elds removed ‘under the delivery jet of the burette. 1.32.2 Run‘in water unt fs levet with she mouth of the tube. ‘ B.3.2.4 Read off the voluime of water delivered to an accuracy of 0,1 mi. Determine the minimum free space by subtracting the volume of water drawn inthe draw volume test (see B2) from the volume of water delivered from the burette, -1$0'6710:1995(E)180°6710:1995(E) Annex C (normative) Test for leakage of container CA Reagents C11 Solution’ prepared by dissolving 2.69 of sodium fluorescein urenine; CAS number 618-47-8)" in 100;mi of 0,18 molt sodium chloride (NaCl; CAS ‘number: 7647-14-6) solution containing 60 gf Dextran 70 [CAS number 9004-64-0] or equivalent: €.1.2 Delonized water thet-shows nb sign of flu- ‘orescence when viewed under ultraviolet light (C.2.2) ina: darkened room by en observer with normal or Corrected:to-normal vision without magnification. €.2 Apparatus €.2.1 “Reservoir {for the sodium fluorescein) re- agent) étteched to 8 convenient lenoth of plasties ‘tubing (@ length of 11m hes: been found suitable). When testing an evacusted container, the tubing shall be fitted with a blood collection needle es rec: ‘ommended by the manufacturer: When testing other containers, the tubing shall be fitted with @ hollow tip ‘oF figid material thst terminates ih a conical male ft- ting with a 6% Luer taper which complies: with 1s0 594-1, €.2.2 Long-wave ultraviolet light (UV) souree €.23 Rollertype mixer or other mixer rec: ‘ommended by the manufacturer of the container. €.2.4 Torque wrench (where necessary) 3 Test procedure for non-evacuated container €.3.1" Fill the reservoir with ‘the ‘teagent (C.1.1). €.3.2 Remove thé closure from the tube ‘and fit to its nominal capacity ftom the teservolr, taking care ‘hot fo contaminate the outside of the tube and the tube rim with the reagent. Fit the closure exactly es 1) CAS number means Chemical Abstracts Service Registry Number. ‘Specified by the manufecturer: Tighten semua ‘the manufacturer's: specified ‘closing iene ush pustrin-ceps firmly home into the: mouth of Push shap-on caps firmly home’ over the: irwcth tube: 2 C.3.3 With “inair of eee Mision without magnification, exeminé the’ ‘container in darkened room: to ensiire that there Is no sufece! ‘contaminstion with the reagent. If necessary wash off yntamnination with the water, examining under UV light as before. ©.3.4 Rotate the container on the rollertype mixer ‘or 2 min or mix 8s recommended by the -mantutae- ‘turer of the container. Immerse the container upside ‘down ii'e-vessel'contalning riot fid?@ than 100ml of the water to cover the closure completely. Leave et. between. 187C end 20°C for 60 min. Remove the container fromthe water and. examine. ‘the water under UV fight as described in C.38.: C.4 Test procedure for evacuated container C.4.1. Fill the reservoir with the reagent (C.1.1). C.4.2._Fill:the container to its ‘nominal capacity from. the reservoir fitted with the blood collection needle, taking care ‘not to. contaminate the ‘outside of the ‘container with the reagent. When the container hes been filed, remove it from the needle and wash the outside of the tube and closure free of any contami- Ration with the reagent, examining under UV light 2s described in C33. C.4.3 Follow the procedure described in C34. ©.5. Procedure for containers designed t be filled either by perforation of closur or following removal of closure C.5.1. Fill the reser(oir with the reagent (C.1.1):