ASTM E734-1980(2015) 4504 Standard Specification for Disposable Glass Blood Sample Capillary Tube (Microhematocrit)《一次性玻璃血样毛细管 (微量血细胞比容) 的标准规格》.pdf

1、Designation: E734 80 (Reapproved 2015)Standard Specification forDisposable Glass Blood Sample Capillary Tube(Microhematocrit)1This standard is issued under the fixed designation E734; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision,

2、 the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This specification covers disposable glass blood samplecapillary tubes for use in microhematocrit procedu

3、res.1.2 The values stated in SI units are to be regarded asstandard. No other units of measurement are included in thisstandard.2. Referenced Documents2.1 ASTM Standards:2E438 Specification for Glasses in Laboratory Apparatus2.2 Other Standard:USP XIX United States Pharmacopeia3. Terminology3.1 Defi

4、nitions of Terms Specific to This Standard:3.1.1 disposable capillary tubes, nin accordance with thisspecification and the expected product performance expressedin this standard, those capillary tubes which are to be used onetime only. Any institution or individual who reuses a dispos-able capillary

5、 tube must bear full responsibility for its safetyand effectiveness.4. Classification4.1 This specification covers two different disposable glasssample capillary tubes as follows:Type ICoated with heparin.Type IIUncoated.5. Materials5.1 GlassThe pipets made to this specification shall befabricated f

6、rom borosilicate glass, Type I, Class B, or soda-lime glass, Type II, in accordance with Specification E438.5.2 HeparinHeparin shall be of ammonium salt isolatedfrom the lungs or intestinal mucosa of beef or pork origin. Theheparin potency shall be 1 mg of ammonium heparin com-pound which shall be e

7、qual to at least 60 United StatesPharmacopeia (USP) units. Dry or wet heparin may be appliedto the tube.6. Physical Requirements6.1 DesignThe capillary tubes shall be straight and openat both ends without lip or constriction. The capillary tube maybe lightly firepolished on one end. The bore of the

8、tube shall beuniform and not vary in excess of 0.025 mm in 75 mm.6.2 DimensionsType I and Type II capillary tubes shallhave a length of 75 6 0.5 mm. Inside diameter shall be from1.07 to 1.24 mm. Wall thickness shall be 0.20 + 0.03, 0.02mm, as specified in Fig. 1.6.3 WorkmanshipThe capillary tubes sh

9、all be free ofdefects that noticeably detract from their appearance or impairtheir serviceability. The capillary tube shall be free of lint, orsignificant foreign matter, loose or embedded, when viewedunder normal room lighting. The tube ends shall be cutapproximately 90 to the tube axis and shall n

10、ot be cracked orhave jagged ends or chips that enter the bore of the tubing.6.4 Color CodingEach capillary tube shall be color codedto identify the tube as coated with heparin or uncoated. Type I,heparin coated, shall have a red band and Type II, uncoated,shall have a blue band. The location of the

11、red or blue bandshall be as specified in Fig. 1.6.5 CapillarityThe capillary tube shall be capable ofdrawing sheep plasma or human whole blood to a level within20 mm from the far end of the tube when tested as specified in7.1.6.6 Fluidity (Type I, Heparinized, only)Coagulation of thesheep plasma or

12、human whole blood shall not be evident whenviewed under normal room lighting and tested as specified in7.2.6.7 Lot or Control NumberA lot or control number shallbe indicated on the capillary tube unit container and on theintermediate package of containers. This lot or control numbershall be traceabl

13、e to the origin (raw material purchases) of themanufacturing record.1This specification is under the jurisdiction of ASTM Committee E41 onLaboratory Apparatus and is the direct responsibility of Subcommittee E41.01 onLaboratory Ware and Supplies.Current edition approved June 1, 2015. Published July

14、2015. Originally approvedin 1980. Last previous edition approved in 2010 as E734 80 (2010). DOI:10.1520/E0734-80R15.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to

15、the standards Document Summary page onthe ASTM website.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States16.8 Resistance to Centrifugal ForceResistance to capil-lary tube centrifugal force shall be such that no breakageresults when the t

16、ubes are tested as specified in 7.4.6.9 Heparin Coating (Type I, Heparinized, only)The in-ner surface of Type I capillary tubes shall be evenly coatedwith ammonium heparin. A minimum of 2.0 units of heparinactivity shall be present in the tube when tested as specified in7.3.Astatement on expected un

17、its of heparin and an expirationdate may be claimed by the manufacturer. This option may beexpressed on the label.7. Test Methods7.1 Capillary TestTest sample capillary tubes for capillar-ity when held at a horizontal level. The tube shall fill withsheep plasma or human whole blood within a 15-s tim

18、einterval.7.1.1 When using a sealant, the tube may not be filledcompletely to allow for dry space to be occupied by the sealantand avoid leakage.7.2 FluidityTest capillary tubes for fluidity by one of thefollowing methods:7.2.1 Sheep Plasma TestConduct the test initially bypreparing recalcified shee

19、p plasma by the following process:7.2.1.1 Prepare sheep plasma in accordance with USP assayfor sodium heparin.7.2.1.2 Add 10 mL of the prepared sheep plasma to 2.0 mLof the 1.0 % calcium chloride solution used in the heparinassay. Mix the sheep plasma and calcium chloride solutionwell.7.2.2 Controls

20、Use samples of both the plain sheep plasmaand recalcified sheep plasma as controls in accordance with thefollowing:FIG. 1 Type I and Type II Capillary TubesE734 80 (2015)27.2.2.1 Positive ControlFill a plain (that is, nonheparin-ized) capillary tube with recalcified sheep plasma.7.2.2.2 Negative Con

21、trolFill a heparinized capillary tubewith plain sheep plasma. Immediately after the preparation ofthe recalcified sheep plasma, fill the capillary tubes by immers-ing the tips in the recalcified sheep plasma and holding thetubes at such an angle as to facilitate quick filling. Fill thecapillary tube

22、s to within 5 mm from the other end and place ina horizontal position. At the end of 1 h, inspect the tubescontaining plasma for evidence of coagulation by carefullysnapping off segments of tubing, in approximately 25-mmlengths, and place on a flat surface. (Use a black background tofacilitate obser

23、vation and comparing with the control sample.)Coagulation has occurred if the sheep plasma becomes opaqueor if a fine fribin thread is noted.7.2.3 Human Whole Blood TestHuman whole blood maybe used instead of sheep plasma by following the steps outlinedin 7.2.1. The testing laboratory shall use a kn

24、own donor thatdoes not have clotting mechanism deficiencies as a control.7.3 Heparin Potency AssayDetermine heparin potency bythe test procedure outlined in the latest edition of the UnitedStates Pharmacopeia (USP) or other acceptable methodologythat will correlate and provide equivalent test result

25、s.7.4 Resistance to Centrifugal Force TestFill the capillaryto capacity with distilled water or whole human blood and sealand suspend in a centrifuge. Accelerate the centrifuge gradu-ally to a speed of 12 000 rpm. Allow the centrifuge to run at12 000 rpm for 4 min only; then shut off and allow to st

26、opwithout using the brake.7.5 Heparin Content TestDetermine the heparin content inthe capillary tube by the method for assaying sodium heparinspecified in the latest edition of the United States Pharmaco-peia (USP), or other acceptable methodology that will correlateand provide equivalent test resul

27、ts. The results obtained shallrepresent the heparin content on the inner surfaces of the tubes.No heparin from the outside of the tubes surface shall enter thetest sample.8. Keywords8.1 blood; capillary; disposable; glass ; tubesASTM International takes no position respecting the validity of any pat

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30、ents will receive careful consideration at a meeting of theresponsible technical committee, which you may attend. If you feel that your comments have not received a fair hearing you shouldmake your views known to the ASTM Committee on Standards, at the address shown below.This standard is copyrighte

31、d by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,United States. Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org). Permission rights to photocopy the standard may also be secured from the Copyright Clearance Center, 222Rosewood Drive, Danvers, MA 01923, Tel: (978) 646-2600; http:/ 80 (2015)3