ASTM E734-1980(2005) Standard Specification for Disposable Glass Blood Sample Capillary Tube (Microhematocrit)《一次性血液样品毛细玻璃试管(血球容量计)的标准规范》.pdf

1、Designation: E 734 80 (Reapproved 2005)Standard Specification forDisposable Glass Blood Sample Capillary Tube(Microhematocrit)1This standard is issued under the fixed designation E 734; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revisio

2、n, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) 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 proc

3、edures.2. Referenced Documents2.1 ASTM Standards:2E 438 Specification for Glasses in Laboratory Apparatus2.2 Other Standard:USP XIX United States Pharmacopeia3. Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 disposable capillary tubesin accordance with thisspecification and the

4、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 tube must bear full responsibility for its safetyand effectiveness.4. Classification4.1 This specification covers two diff

5、erent disposable glasssample capillary tubes as follows:Type ICoated with heparin.Type IIUncoated.5. Materials5.1 GlassThe pipets made to this specification shall befabricated from borosilicate glass, Type I, Class B, or soda-lime glass, Type II, in accordance with Specification E 438.5.2 HeparinHep

6、arin 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 equal to at least 60 United StatesPharmacopeia (USP) units. Dry or wet heparin may be appliedto the tube.6. Physical Requir

7、ements 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 tube shall beuniform and not vary in excess of 0.025 mm in 75 mm.6.2 DimensionsType I and Type II ca

8、pillary 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 shall be free ofdefects that noticeably detract from their appearance or impairtheir serviceability. T

9、he 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 not be cracked orhave jagged ends or chips that enter the bore of the tubing.6.4 Color CodingEach cap

10、illary 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 red or blue bandshall be as specified in Fig. 1.6.5 CapillarityThe capillary tube shall be capable o

11、fdrawing 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 human whole blood shall not be evident whenviewed under normal room lighting and tested as specified

12、 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 number1This specification is under the jurisdiction of ASTM Committee E41 onLaboratory Apparatus and is the direct responsi

13、bility of Subcommittee E41.01 onApparatus.Current edition approved May 1, 2005. Published October 2005. Originallyapproved in 1980. Last previous edition approved in 1999 as E 73480 (1999)e1.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serv

14、iceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.shall be traceable to the origin (raw material purchase

15、s) of themanufacturing record.6.8 Resistance to Centrifugal Force Resistance to capil-lary tube centrifugal force shall be such that no breakageresults when the tubes 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 e

16、venly 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 units of heparin and an expirationdate may be claimed by the manufacturer. This option may beexpressed on the label.7. Test Methods7.1 Capil

17、lary 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 timeinterval.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 l

18、eakage.7.2 FluidityTest capillary tubes for fluidity by one of thefollowing methods:FIG. 1 Type I and Type II Capillary TubesE 734 80 (2005)27.2.1 Sheep Plasma TestConduct the test initially bypreparing recalcified sheep plasma by the following process:7.2.1.1 Prepare sheep plasma in acordance with

19、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 ControlsUse samples of both the plain sheep plasmaand recalcified sheep plasma as controls

20、 in accordance with thefollowing:7.2.2.1 Positive ControlFill a plain (that is, nonheparin-ized) capillary tube with recalcified sheep plasma.7.2.2.2 Negative ControlFill a heparinized capillary tubewith plain sheep plasma. Immediately after the preparation ofthe recalcified sheep plasma, fill the c

21、apillary 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 tubes 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

22、of coagulation by carefullysnapping off segments of tubing, in approximately 25-mmlengths, and place on a flat surface. (Use a black background tofacilitate observation and comparing with the control sample.)Coagulation has occurred if the sheep plasma becomes opaqueor if a fine fribin thread is not

23、ed.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 known donor thatdoes not have clotting mechanism deficiencies as a control.7.3 Heparin Potency AssayDetermine heparin potency bythe test pro

24、cedure outlined in the latest edition of the UnitedStates Pharmacopeia (USP) or other acceptable methodologythat will correlate and provide equivalent test results.7.4 Resistance to Centrifugal Force TestFill the capillaryto capacity with distilled water or whole human blood and sealand suspend in a

25、 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 stopwithout using the brake.7.5 Heparin Content TestDetermine the heparin contentin the capillary tube by the method for assaying sodium hep

26、arinspecified in the latest edition of the United States Pharma-copeia (USP), or other acceptable methodology that willcorrelate and provide equivalent test results. The resultsobtained shall represent the heparin content on the innersurfaces of the tubes. No heparin from the outside of the tubessur

27、face shall enter the test sample.8. Keywords8.1 blood; capillary; disposable; glass; tubesASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin this standard. Users of this standard are expressly advised that determination

28、of the validity of any such patent rights, and the riskof infringement of such rights, are entirely their own responsibility.This standard is subject to revision at any time by the responsible technical committee and must be reviewed every five years andif not revised, either reapproved or withdrawn

29、. Your comments are invited either for revision of this standard or for additional standardsand should be addressed to ASTM International Headquarters. Your comments will receive careful consideration at a meeting of theresponsible technical committee, which you may attend. If you feel that your com

30、ments 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 copyrighted 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).E 734 80 (2005)3