Texas Specification No. 475-82-01
Effective Date: July 30, 1971
Reformatted: December 18, 1995
SYRINGES, HYPODERMIC, STERILE, SINGLE INJECTION, DISPOSABLE
1. SCOPE: This specification establishes the minimum requirements for disposable, autoclavable, hypodermic syringes with or without assembled needles, and intended for single injections of parenteral solutions. The syringe assembly (barrel, plunger, plunger gasket, needle assembly in Style "B" and Style "C" syringes, and lubricant) must be autoclavable. The individual protective container or package does not need to be autoclavable.
2. APPLICABLE SPECIFICATIONS AND STANDARDS: References to specifications, standards and test methods shall be to the issues in effect on the date of the Invitation for Bids.
3. DEFINITIONS: Terminology used in this specification is intended to be generic in nature and consistent with meanings that have been defined through general use and/or accepted trade practices. Where variant meanings may exist, the applicable interpretation shall be determined by the Texas Procurement and Support Services (TPASS).
3.1. COMMISSION: Texas Procurement and Support Services (TPASS).
4. REQUIREMENTS: Disposable syringes furnished under this specification shall meet or exceed the following minimum requirements:
4.1. STYLE: Must be specified on the Invitation for Bids.
4.1.1. Style "A": Shall be the type wherein the needle and needle hub is detachable from the barrel. These syringes are to be furnished without needles.
4.1.2. Style "B": Shall be the same syringe as Style "A", except it is to be furnished with a detachable disposable needle assembly that conforms with Texas Specification No. 475-82-02A.
4.1.3. Style "C": Shall be the type wherein the needle hub is securely swaged, crimped or otherwise permanently affixed to the barrel tip and is not detachable other than by breaking. The needle assembly must conform with Texas Specification No. 475-82-02A.
4.2.1. Syringe Sizes: Syringe sizes shall be designated by specific size numbers that correspond to the following capacities in cubic centimeters. The size numbers furnished shall be as specified in the Invitation for Bids.
4.2.2. Needle Sizes: The needle sizes (length and gauge), point and hub styles are specified in Texas Specification No. 475-82-02A. The needle requirements shall be specified in the Invitation for Bids. (See Texas Specification No. 475-82-02A for ordering information.)
|Syringe Size||Syringe Capacity|
|Size 1||1 through 1-1/2 cc.|
|Size 2||2 through 3 cc.|
|Size 3||5 through 6 cc.|
|Size 4||10 through 12 cc.|
|Size 5||20 through 25 cc.|
|Size 6||20 through 35 cc.|
|Size 7||50 through 60 cc.|
4.3. Material: All material shall comply with the requirements of the Federal Food, Drug and Cosmetic Act. The portions of the unit that comes into contact with the fluid to be injected shall be compatible with the United State Pharmacopoeia Drugs.
4.3.1. Barrel: The syringe barrel shall be transparent, sterile, non-pyrogenic and autoclavable. The choice of composition of the barrel shall be the prerogative of the manufacturer, but shall be one of the following:
220.127.116.11. Plastic: Shall be virgin, non-toxic, high-grade throughout, and shall be free from reground or reclaimed material. The plastic shall be a rigid polypropylene, that will not produce harmful or deleterious effects or reactions on the known parenteral medicants being handled.
18.104.22.168. Glass: Shall be a high-grade, corrosion resistant, borosilicate glass.
4.3.2. Plunger: The plunger shall be made of rigid autoclavable polypropylene plastic.
4.3.3. Plunger Gasket: The plunger gasket shall be made of fresh-stock, pharmaceutical grade, high-grade natural rubber or neoprene combinations processed for this application. The gasket material shall be inert, sterile, non-blooming, non-leaching, non-toxic, autoclavable and age resistant.
4.3.4. Needle Assembly: Shall conform to Texas Specification No. 475-82-02A.
4.3.5. Lubricant - Barrel and plunger Gasket Coating: This shall be an inert, non-toxic, silicone suitable for the specific use. It shall serve as a siliconizing coating on all interior surfaces of the syringes that may come in contact with the liquid content. The silicone must be a high pharmaceutical grade.
4.3.6. Individual Protective Container or Package: The shape and type of container or package is the prerogative of the manufacturer; however, the container or package must be tamper-proof so as to retain the sterility of the enclosed syringe assembly (Refer to Paragraphs 1, 4.3., and 9). The sealed (sterile) container or package must be so designed as to permit ready dispensing of syringes by sterile techniques.
4.4. DESIGN AND CONSTRUCTION:
4.4.1. Syringe: The syringe shall consist of a barrel, plunger, plunger gasket or piston, and protective container (Style "B" and Style "C" syringes include needle assembly and protective sheath) assembled ready for use.
4.4.2. Barrel: The plastic or glass barrel shall be a tube closed at one end, except for an effluent and open at the other end. It shall provide good visibility of medicants and be constructed within the dimensions specified in Table 1, Barrel Dimensions. At the closed end, a Luer tip shall be formed for attachment of the syringe needle. The wall at the open end (proximal end) shall be thickened and extended radially outward to form a flange to prevent slipping of the barrel through the fingers. The inside surface of the barrel shall be a very fine uniform surface, free from pits, grind marks, or open air line. The inside of the barrel shall be lightly coated with silicone lubricant as specified in Paragraph 4.3.5.
|Syringe Size||Capacity (In cubic centimeters)||Overall Length Including Tip||Inside Diameter||Sub Graduations||Main Graduations||Pressure Test Minimum Pressures for Tests in Paragraphs 6a & 6b|
|1.00||1 through 1-1/2 cc||2.45 - 3.40||0.165 - 0.255||0.01||0.1 3||45.00|
|2.00||2 through 3 cc||2.10 - 3.10||0.330 - 0.420||0.1||0.5||50.00|
|3.00||5 through 6 cc||2.75 - 3.50||0.450 - 0.600||0.2||1.0||45|
|4.00||10 through 12||3.50 - 4.30||0.550 - 0.700||0.2||1.0||40.00|
|5.00||20 through 25||3.80 - 5.00||0.650 - 0.880||1.0||5.0||35.00|
|6.00||30 through 35||4.35 - 5.40||0.846 - 1.000||1.0||5.0||30.00|
|7.00||50 through 60||5.00 - 6.25||1.024 -1.250||1.0 or 5.0||5.0 or 10.0||20.00|
4.2.3. Flange: The form and dimensions of the flange shall be appropriate to the size of the barrel; in all cases it shall extend outward from the wall sufficient to give ample finger hold and lengthwise of the barrel to give strength and durability. Opposite segments of the flange shall be removed to provide straight parallel side of ample length to prevent rolling.
4.2.4. Tip: the tip shall be formed concentric to the axis of the barrel and shall make a mechanically stable, fluid tight connection (Paragraphs 6.1.1. and 6.1.2.) with a hypodermic needle having a Luer hub with hub cavity in accordance with Figure 2 (female end) of ANSI Standard Z70.1-1955/UDC 615.47.
4.2.5. Graduations and Other Markings: The phrase, "Discard After Use", or similar legend denoting one time use shall be marked on the outside of the barrel and/or the syringe container. The graduation scale, specified in Table 1, Barrel Dimensions, shall be marked on the outside of the barrel. The graduations shall be applied to the barrel in such a manner that they are approximately in line with one flattened side of the flange. Main graduation marks shall be at least 33-1/3 percent longer than the sub-graduation marks; and the "O" mark of the scale shall register precisely with the extreme distal end of the plunger gasket when the plunger is pushed to the bottom of the barrel. Barrel markings shall be red, black or other dark color, clear and legible, and of a type ink or pigment that is resistant to abrasion and will not easily rub or be marred during use or shipment. The marking pigment or ink shall withstand the tests required in Paragraph 6.1.4.
4.2.6. Plunger: Plungers shall be either hollow, solid, or of a structural shape designed to provide adequate plunger strength. The distal end of the plunger shall be shaped to permit attachment of a plunger gasket. The proximal end of the plunger shall extend well out of the barrel and be shaped to form a button type knob of a thickness and diameter appropriate to the size of the syringe or shaped to form a hood over the outside of the barrel.
4.2.7. Plunger Gasket or Piston: The plunger gasket or piston shall fit the barrel accurately so as to permit the syringe to successfully stand the applicable pressure and leak test prescribed in Paragraphs 6.1.1. and 6.1.2., and yet permit the plunger gasket to move freely and smoothly throughout its excursion of the barrel. Plunger gasket or piston shall not become loose from plunger after being moistened with medication, and shall be properly treated with a silicone lubricant, to allow it to draw and move freely and smoothly. An excess of lubricant that detracts from the appearance or can by hydraulically washed out with the medicant being used, is cause for rejection. The distal end of the plunger gasket shall be of such design that substantially all of the medication fluid shall be removed from syringe barrel when plunger gasket is at zero dosage mark. The plunger gasket shall be of a permanently dark color so that the first ring at the plunger gasket distal end, touching the sides of the barrel, shall be clearly visible and accurately indicated through the barrel wall.
4.2.8. Needle: Shall conform to the requirements for canula, point, hub and needle protector in Texas Specification No. 475-82-02A.
4.2.9. Workmanship: Workmanship shall be first class in every respect, free from any defect affecting appearance, safety, or use for which it is intended. The fluid path of the syringe (and needle in Style "B" and Style "C" syringes) shall be free from lint, dirt, or other particulate matter.
4.3. STERILITY: Each syringe shall be completely sterilized, non-toxic, free from pyrogens and individually and securely packaged in a suitable container to maintain sterility. Each individual protective container or package shall bear a sterility, non-pyrogenic and non-toxicity certification or its equivalent. (See Paragraphs 6.1.6., 6.1.7., and 6.1.8.)
5. SAMPLES: Unless otherwise specified in the Invitation for Bids, no prepurchase samples shall be required. Samples tested shall be taken from regular orders.
6. TESTING: Testing shall be done by or at the direction of, the Commission and/or the receiving State agency. Tests shall be performed on products from shipments to ordering agencies. In the event products tested fail to meet or exceed all conditions and requirements of this specification, the cost of the samples used and the cost of testing shall be borne by the supplier.
6.1. TESTS: The product furnished under this specification shall be tested by the following methods or approved equally applicable procedures:
6.1.1. Pressure Test: When tested on a water pressure testing machine, the minimum test pressure that the different capacity syringes must withstand are shown in Column 7, Table 1.
6.1.2. Leakage Test: Pressures used shall be as specified in Column 7, Table 1. The water used as a testing fluid shall be let in through the needle until the pressure is raised to the value specified in Column 7, Table 1. The plunger shall be drawn to a point half of the distance of the graduations where it shall be allowed to remain for ten (10) seconds. The plunger shall then be drawn back to midway between the first position and the top graduation mark where it shall be allowed to remain for a similar length of time. The syringe shall be tested in a horizontal position. During each test, there shall not be enough water pass the connection of the canula with the hub, the connection of the hub with the syringe tip, or connection of the canula with syringe tip where no hub is used, or plunger gasket, to produce a falling drop. After each successive test, any water that may have passed shall be wiped away and the next test applied.
6.1.3. Needle Test: Needle assembly testing shall be performed in accordance with the tests described in Texas Specification No. 475-82-02A.
6.1.4. Test for Permanency of Pigment: Syringes shall be soaked in water for three (3) hours without removing pigment. Pigment should not show appreciable fading when exposed to direct sunlight for twenty-four (24) hours.
6.1.5. Cleanliness Test: The syringe shall be first visually examined for obvious foreign matter and then shall be submitted to the following test:
22.214.171.124. Test Material: Shall be a high viscosity, soft, smooth-textured white substance or paste. Before testing syringe and needle, the test material shall be examined closely under 10 power magnification for foreign matter or coloring. Any dark gray or black specks, spots or streaks shall indicate foreign particles and new test material shall be selected, sampled and examined until suitable. A representative sample shall be retained for comparison and control purposes with test specimen.
126.96.36.199. Test: A quantity of the test material sufficient to perform the test but not less than one (1) cubic centimeter shall be filled into each of the sample syringes with the plungers withdrawn. The plunger is carefully inserted and test material slowly forced through each syringe. Test specimens shall be the first deposit forced through each syringe. This deposit shall be spread on white bond paper and examined for presence of foreign matter. The examination shall consist of a comparison with the original test material, both under 10 power magnification and without magnification, using ordinary laboratory lighting.
6.1.6. Sterility Test: The sterility test shall be performed under Sterility Tests in the current edition of the United States Pharmacopoeia.
6.1.7. Pyrogen Test: Freedom from pyrogen test shall be performed in accordance with the current edition of the United State Pharmacopoeia.
6.1.8. Safety Tests:
188.8.131.52. Toxicity: The plastic syringes and tip protectors shall be tested for toxicity in accordance with the "Suggested Protocol for Biological Testing of Plastics to be Used in Medical Practice", by Guess and Autian. The pertinent portions of this procedure are: Part I, Sections A and B, and Part II, Section A on page 262; and Part III, Section A and B, page 263.
184.108.40.206. Heavy Metals: An acid extraction of the plastic syringes and tip protectors shall show that the extractable heavy metals, such as lead, shall be less than 10 ppm.
6.1.9. Autoclavability Test: Syringe assembly (and needle assembly in Style "B" and Style "C" syringes) shall be subject to autoclave sterilization for 20 minutes at 250 °F under steam pressure. At the end of such time, the plunger shall be freely movable in the barrel. The syringe assembly (and needle assembly in Style "B" and Style "C" syringes) must function properly after autoclaving.
7. INSPECTION: Products furnished under this specification shall be inspected by, or at the direction of the Commission and/or the ordering State agency either at the destination or place of manufacture.
8. PACKING / PACKAGING: Packing for shipment shall be in accordance with the manufacturer's standard practice and in a manner readily accepted by common carriers engaged in interstate commerce. Within the shipping carton, units shall be packed in a manner designed to minimize damage during the shipment because of rough or improper handling.
8.1. PACKING: Each syringe and or needle assembly shall be individually and securely packaged (See Paragraph 4.3.) in a suitable container to maintain sterility of the syringe and/or needle assembly until the container is opened. The marking shall be in accordance with Paragraph 9. Each unit shall be packaged in a standard commercial container; the size and type of package is the option of the vendor.
9. MARKING / LABELING:
9.1. MARKING: Each syringe assembly and/or container or package shall be marked or labeled with the applicable commercial description including capacity of syringe, (gauge and length of needle in Style "B" and Style "C: syringes), lot or control number, manufacturer's name or trademark and the following four terms: (1) Sterile; (2) Non-Pyrogenic or Pyrogen-Free; (3) Non-Toxic; and (4) Disposable or equivalent to denote one time use only. These four terms should be shown in such a manner as to be easily read. Each shipping container shall be clearly marked with the following data:
9.1.1. This specification number (475-82-01A).
9.1.2. Name of contents.
9.1.3. Quantity contained.
9.1.4. Order number or contract number.
9.1.5. Name and address of ordering agency.
9.1.6. Agency requisition number.
9.1.7. Name and address of manufacturer.
10. COMPLIANCE: In order for consideration to be given to the bid on an item under this specification, the bidder must comply with the following:
10.1. PRODUCT IDENTIFICATION: The make, model number, name of the manufacturer, brand or trade name, etc., as applicable, of the item which the vendor proposes to furnish must be stated as part of the bid.
10.2. EXCEPTIONS: Notwithstanding the above, any exception taken by the bidder to the requirements and conditions of this specification must be stated and described in detail as a part of the bid. If no exceptions or deviations are identified in this manner, the items must be furnished exactly as described herein.
10.3. PROOF: The bidder shall bear the burden of proof of compliance with this specification.
11. ORDERING DATA: When ordering products conforming to this specification the requisitioning agency shall specify the following:
14.1. The number of this specification (475-82-01).
14.2. For Style "A" Syringe:
14.2.1. Style of syringe;
14.2.2. Size number of syringe;
14.2.3. Quantity of each; unit of measure for quantity desired must be stated as each. Do not specify cartons or cases containing given quantities.
14.3. For Style "B" and Style "C" syringes:
14.3.1. Style of syringe;
14.3.2. Size number of syringe;
14.3.3. Gauge, length and point style of needle (Refer to Texas Specification No. 475-82-02A);
14.3.4. Quantity of each; unit o measure for quantity desired must be stated as each. Do not specify cartons or cases containing given quantities.
15. AVAILABILITY OF SPECIFICATIONS: Copies of this specification may be obtained by calling or writing:
Texas Procurement and Support Services
Austin, TX 78711-3047