ASTM E1093-1991(2012) 6250 Standard Specification for Glass Prothrombin Pipet Disposable《一次性的凝血酶原玻璃吸管的标准规范》.pdf

1、Designation: E1093 91 (Reapproved 2012)Standard Specification forGlass Prothrombin Pipet, Disposable1This standard is issued under the fixed designation E1093; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revisi

2、on. 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 a glass disposable Prothrombinpipet suitable for use in micro techniques for estimation ofProthrombin t

3、ime.1.2 The values stated in SI units are to be regarded asstandard. No other units of measurement are included in thisstandard.1.3 This precautionary statement pertains only to the testmethod portion, Section 8, of this specification. This standarddoes not purport to address all of the safety conce

4、rns, if any,associated with its use. It is the responsibility of the user of thisstandard to establish appropriate safety and health practicesand determine the applicability of regulatory limitations priorto use.2. Referenced Documents2.1 ASTM Standards:2E438 Specification for Glasses in Laboratory

5、Apparatus2.2 ISO Standard:31769 Laboratory GlasswarePipettesColor Coding3. Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 accuracythe expected distribution of mean volumesaround the stated volume.3.1.2 coeffcient of variationthe expected distribution ofindividual volumes around

6、the mean volume.3.1.3 disposableProthrombin pipets which are intended tobe used once only and then discarded.NOTE 1Such pipets will only be expected to provide their specifiedperformance during the original operation.4. Classification4.1 This specification covers only one glass pipet as illus-trated

7、 in Fig. X1.1.5. Materials and Manufacture5.1 The pipet shall be made of borosilicate glass, Type 1;Class B, or soda lime glass, Type 2, in accordance withSpecification E438.6. Physical Properties6.1 DesignThe Prothrombin pipet shall be made of onepiece construction glass tubing that is straight and

8、 with uniformbore and lightly firepolished on both ends. The pipet shall bemade to the dimensions as specified in Fig. X1.1.6.2 DimensionsThe pipet shall be made of tubing with aminimum outside diameter (o.d.) of 2.3 mm with an insidediameter (i.d.) of 1.7 mm. The uniformity of the bore shall be60.0

9、5 mm throughout the straight portion of the pipet. Thepipet shall be a minimum of 160 mm long.6.3 CapacityThe pipet shall be calibrated “to deliver”(T.D.) 0.1 and 0.2 mL at 20C. Marking shall be as specified in6.5.6.3.1 Accuracy (see 3.1.1)The accuracy from stated vol-ume shall be 62.0 % for the 0.1

10、 and 0.2-mL capacity and shallbe determined as specified in 8.1.6.3.2 Coeffcient of Variation (see 3.1.2)The coefficient ofvariation from stated volume for the 0.1 and 0.2-mL capacityshall not exceed 2.0 % and shall be determined as specified in8.1.6.4 Graduation LinesThe pipet shall be calibrated a

11、ndmarked with graduation lines at 0.1 and 0.2 mL from the tip ofthe pipet. The graduation lines shall be 0.3 6 0.1 mm and shallcompletely encircle the tube.6.5 Pipet NomenclatureThe pipet shall be marked with0.1 and 0.2-mL markings slightly above the graduation lines.The pipet may be marked with the

12、 inscription T.D. 20C, or themanufacturers or vendors name or trademark, or both.6.6 Blow-out DeliveryThe Prothrombin pipet is designedas a dual delivery system for the determinations of coagulationassays. When utilizing the 0.2 mL calibration line, the tip of thepipet should contact the wall of the

13、 receiving vessel and allowthe pipet to drain freely. The remaining quantity of liquid is to1This specification is under the jurisdiction of ASTM Committee E41 onLaboratory Apparatus and is the direct responsibility of Subcommittee E41.01 onApparatus.Current edition approved Nov. 1, 2012. Published

14、November 2012. Originallyapproved in 1986. Last previous edition approved in 2005 as E1093 91 (2005).DOI: 10.1520/E1093-91R12.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information,

15、 refer to the standards Document Summary page onthe ASTM website.3Available from ISO, 1 Rue de Varembe, Case Postal 56, Crt 1221, Geneva 20,Switzerland.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States1be blown out into the center of th

16、e receiving vessel. Whenutilizing the 0.1 mL calibration line the contents are to bevigorously blown out into the center of the receiving vesselwith one quick effort. Either one band or two narrow bandsshall encircle the top end of the pipet to signify the contentsmust be blown out as shown in Fig.

17、X1.1.6.7 Color CodingThe pipet shall be color coded forcapacity as specified in ISO Standard 1769 with an “orange”color band that is 6 6 2 mm wide and located 16 6 2 mm fromthe top of the pipet as shown in Fig. X1.1.6.8 Marking PermanencyGraduation lines, inscriptions,and numerical markings on the p

18、ipet (other than the color codeband) shall be black in color. All markings may not be ofpermanent nature but must possess sufficient stability to endurenormal transportation and its expected one-time use and mustmeet the test requirements as specified in 8.5.6.9 Lot ControlA lot or control number sh

19、all be indicatedon the pipet container package. This lot or control number shallbe traceable to the origin and purchase order of raw materialglass tubing.7. Workmanship, Finish, and Appearance7.1 The pipet shall be as free as possible of visible defectswhich would detract from its appearance or impa

20、ir its service-ability when viewed by the human eye under normal roomlighting.8. Test Method8.1 Capacity:8.1.1 Weighing Volume, Using WaterAllow a small vessel(5-mL beaker) and a container of distilled water to stand atroom temperature of 20 to 25C for 2 h. Weigh the dry vesseland record the weight.

21、 Fill the pipet with water and adjust tothe calibration line. Deliver the contents of the pipet in theprescribed manner into the vessel. Reweigh the vessel withwater content and record the weight. Record the room tem-perature. Subtract the recorded weight of the dry vessel fromthe recorded weight of

22、 the water-containing vessel to obtain theapparent mass of the contained water. Calculate the volume, V,in accordance with the appendix.NOTE 2To accurately perform this test method, the reliability of theweighing instrument used should be confirmed against a known standardand the weighing instrument

23、 should possess a minimum sensitivity of0.01 mg.8.2 CalculationCalculate the volume, V, of a micropipetfrom the weighings, in air, as follows:V 5 W 3Z (1)where:W = apparent mass of liquid (water), weighed in air, andZ = apparent specific volume of liquid (water).Values of Z for water are given in th

24、e appendix.8.3 Capacity Deviation (single pipet)In accordance withthe methods outlined, capacity deviation is the differencebetween the stated capacity and the observed capacity of thepipet as follows:Capacity deviations, % 5 Vc2 V1! 3100/V1(2)Vc5 Vt/11at 2 20C! (3)where:Vt= observed volumetric capa

25、city at tC, uL,Vc= corrected volumetric capacity at 20C, uL,a = coefficient of cubical expansion of pipet glass equals0.000010/C for Type 1, Class A (borosilicate);0.000015/C for Type 1, Class B (noncorrosiveborosilicate); and 0.000025/C for Type 2 (soda-lime),V1= stated capacity of pipet, uL, andt

26、= temperature, C.8.4 Capacity Deviation (number of pipets)Test a mini-mum of 30 pipets taken at random from a completed manu-factured production lot. Calculate the volumetric deviation forthe 30 pipets as follows:8.4.1 Accuracy:Accuracy, % 5 100x 2 V1!/V1where:x = mean of sample measurements, andV1=

27、 stated capacity of pipet.8.4.2 Coeffcient of Variation:Coefficent of variation, % 5 100s/x s 5 =x 2 x!2n 2 1 (4)where:x = individual sample measurement,x = mean of sample measurements, andn = number of pipets measured.8.5 Pipet Marking Permanency TestImmerse the tube indistilled water for 30 s. Usi

28、ng a soft paper tissue, wipe themarked portion of the pipet lightly with ten complete strokes(five up and five down). When judged by the naked eye undernormal room lighting the pipet markings should appear asbefore the test with only possible lightening of the markings orminor removal of the marking

29、s, or both, that would not effectthe pipets serviceability.E1093 91 (2012)29. Keywords9.1 disposable; glass; pipet; ProthrombinAPPENDIX(Nonmandatory Information)X1. See Table X1.1 and Fig. X1.1.ASTM International takes no position respecting the validity of any patent rights asserted in connection w

30、ith any item mentionedin this standard. Users of this standard are expressly advised that determination 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 tec

31、hnical committee and must be reviewed every five years andif not revised, either reapproved or withdrawn. 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 considera

32、tion 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 copyrighted by ASTM International, 100 Barr H

33、arbor 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(w

34、ww.astm.org). Permission rights to photocopy the standard may also be secured from the ASTM website (www.astm.org/COPYRIGHT/).TABLE X1.1 Density and Z Factor for WaterTemperature,CDensity,g/cm3Z,cm3/g20 0.99820 1.002921 0.99799 1.003122 0.99777 1.003323 0.99754 1.003524 0.99729 1.003725 0.99704 1.004026 0.99678 1.004227 0.99651 1.004528 0.99623 1.004729 0.99594 1.005130 0.99564 1.0054FIG. X1.1 Glass Prothrombin Pipet, DisposableE1093 91 (2012)3