ASTM E734-80(R2021) pdf free download

ASTM E734-80(R2021) pdf free download.Standard Specification for Disposable Glass Blood Sample Capillary Tube (Microhematocrit)
6. Physical Requirements
6.1 Design—The capillary tubes shall be straight and open at both ends without lip or constriction. The capillary tube may be lightly firepolished on one end. The bore ofthe tube shall be uniform and not vary in excess of 0.025 mm in 75 mm. 6.2 Dimensions—Type I and Type II capillary tubes shall have a length of 75 6 0.5 mm. Inside diameter shall be from 1.07 to 1.24 mm. Wall thickness shall be 0.20 + 0.03, − 0.02 mm, as specified in Fig. 1. 6.3 Workmanship—The capillary tubes shall be free of defects that noticeably detract from their appearance or impair their serviceability. The capillary tube shall be free of lint, or significant foreign matter, loose or embedded, when viewed under normal room lighting. The tube ends shall be cut approximately 90° to the tube axis and shall not be cracked or have jagged ends or chips that enter the bore of the tubing. 6.4 Color Coding—Each capillary tube shall be color coded to 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 band shall be as specified in Fig. 1. 6.5 Capillarity—The capillary tube shall be capable of drawing sheep plasma or human whole blood to a level within 20 mm from the far end of the tube when tested as specified in 7.1.6.6 Fluidity (Type I, Heparinized, only)—Coagulation ofthe sheep plasma or human whole blood shall not be evident when viewed under normal room lighting and tested as specified in 7.2. 6.7 Lot or Control Number—A lot or control number shall be indicated on the capillary tube unit container and on the intermediate package of containers. This lot or control number shall be traceable to the origin (raw material purchases) of the manufacturing record. 6.8 Resistance to Centrifugal Force—Resistance to capil- lary tube centrifugal force shall be such that no breakage results 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 evenly coated with ammonium heparin. A minimum of 2.0 units of heparin activity shall be present in the tube when tested as specified in 7.3. A statement on expected units ofheparin and an expiration date may be claimed by the manufacturer. This option may be expressed on the label.
7. Test Methods
7.1 Capillary Test—Test sample capillary tubes for capillar- ity when held at a horizontal level. The tube shall fill with sheep plasma or human whole blood within a 15-s time interval. 7.1.1 When using a sealant, the tube may not be filled completely to allow for dry space to be occupied by the sealant and avoid leakage. 7.2 Fluidity—Test capillary tubes for fluidity by one of the following methods: 7.2.1 Sheep Plasma Test—Conduct the test initially by preparing recalcified sheep plasma by the following process:7.2.1.1 Prepare sheep plasma in accordance with USP assay for sodium heparin. 7.2.1.2 Add 10 mL of the prepared sheep plasma to 2.0 mL of the 1.0 % calcium chloride solution used in the heparin assay. Mix the sheep plasma and calcium chloride solution well. 7.2.2 Controls—Use samples ofboth the plain sheep plasma and recalcified sheep plasma as controls in accordance with the following: 7.2.2.1 Positive Control—Fill a plain (that is, nonheparin- ized) capillary tube with recalcified sheep plasma. 7.2.2.2 Negative Control—Fill a heparinized capillary tube with plain sheep plasma. Immediately after the preparation of the recalcified sheep plasma, fill the capillary tubes by immers- ing the tips in the recalcified sheep plasma and holding the tubes at such an angle as to facilitate quick filling. Fill the capillary tubes to within 5 mm from the other end and place in a horizontal position. At the end of 1 h, inspect the tubes containing plasma for evidence of coagulation by carefully snapping off segments of tubing, in approximately 25 mm lengths, and place on a flat surface. (Use a black background to facilitate observation and comparing with the control sample.) Coagulation has occurred if the sheep plasma becomes opaque or if a fine fribin thread is noted.