Texas Specification No. 475-82-02
Effective Date: July 30, 1971
Reformatted: December 19, 1995
NEEDLES, HYPODERMIC, STERILE, SINGLE INJECTION, DISPOSABLE
1. SCOPE: This specification establishes the minimum requirements for sterile, single injection, disposable stainless steel hypodermic needles with plastic or metal hubs, for use with glass or plastic syringes equipped with either a plain slip tip (glass, plastic or metal) or Luer lock tip. The needle assembly (canula, hub and canula protector) 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 hypodermic needles furnished under this specification shall meet the following minimum requirements:
4.1. SIZE AND GAUGE: The size and gauge shall conform to Table 1, Dimensions and Gauge of Canula. The size and gauge shall be as specified in the Invitation for Bids.
DIMENSIONS and GAUGE of CANULA
|Gauge||Length in Inches||Outside Diameter
(Maximum in Inches)
|Outside Diameter (Minimum in Inches)||Minimum Diameter of Lumen in Inches|
|21.00||1, 1-1/4, 1-1/2||.0325||.0315||.0195|
4.2. POINT STYLES: The beveled canula tip shall be ground in such a manner as to enhance the keenness of the tip and cutting edge of the bevel. Canulae shall have one of the following point styles, whichever is specified in the Invitation for Bids:
4.2.1. Style "A": Regular (long bevel) point (for subcutaneous and intramuscular injections.
4.2.2. Style "B": Short bevel point (for intravenous injections).
4.2.3. Style "C": Very short bevel point (for intradermal injections).
4.3. HUB: The Luer hub and hub cavity shall be formed in accordance with Figure 2 (female end) of ANSI Standard Z70.1-1955 / UDC.615.47. the hub cavity shall be of such design as to form a mechanically stable fluid tight connection with a hypodermic syringe Luer tip. Style "C" syringe (Texas Specification No. 475-82-01A) is equipped with a permanently affixed needle assembly which cannot be removed expect by breaking.
4.4. MATERIALS: All material shall comply with the requirements of the Federal Food, Drug and Cosmetic Act. The portion of the unit that comes into contact with the fluid to be injected shall be compatible with the United States Pharmacopoeia Drugs.
4.4.1. Canula: The canula shall be a seamless drawn or welded and drawn tube of 18-8 Chrome-Nickel (AISI 304) corrosion resistant steel having the composition identified in Table 2, Canula Composition.
|Chromium||18.0 to 20.0 %|
|Nickel||8.0 to 12.0 %|
|Carbon||0.06 % Maximum|
|Silicon||1.00 % Maximum|
|Sulfur||0.030 % Maximum|
|Phosphorus||0.045 % Maximum|
|Manganese||2.00 % Maximum|
4.4.2. HUB: The hub shall be fabricated from one of the following materials, but the choice of composition of the hub is the prerogative of the manufacturer:
126.96.36.199. Plastic: The plastic shall be a rigid autoclavable polypropylene that is non-pyrogenic, and contains to toxic extrudable materials.
188.8.131.52. Aluminum: Aluminum alloy hubs shall be degreased and anodized or etched and passivated to produce a matte, non-tinted finish.
184.108.40.206. Plated Brass: Brass hubs shall be nickel plated or chromium plated over nickel plate. If the canula is equipped with a brass housing that fits into the hub, the brass must be nickel plated or chromium plated over the nickel plate.
4.4.3. Protector for Canula: The canula is to be encased in a rigid autoclavable polypropylene cartridge shaped protector up to and including two-thirds of the hub, which enables the needle to be attached and detached from the syringe without touching the needle by hand. The protector shall be so designed that it will not fall of or work loose during shipment.
4.4.4. Silicone: Silicone, used to coat the canula, must be inert, non-toxic, pharmaceutical grade and comply with the requirements of the Federal Food, Drug and Cosmetic Act.
4.4.5. Resin: Epoxy resin employed as a cement for attaching the canula to the hub, the hub to the barrel tip (Style "C", Texas Specification No. 475-82-01A), or as a housing on the proximal end of the canula, must be chemically inert to the United State Pharmacopoeia Drugs and must be sterile, non-toxic and autoclavable.
4.4.6. 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 needle assembly (Refer to Paragraphs 1, 4.4.7., and 9). the sealed (sterile) container or package must be so designed as to permit ready dispensing of needles by sterile techniques.
4.4.7. Sterility: Each needle assembly shall be completely sterilized, non-toxic, free from pyrogens and individually and securely packaged in a suitable container to maintain sterility. Each individual 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.).
4.4.8. Workmanship: Workmanship shall be first class throughout. Needles shall be free from defects which detract from their appearance or may impair their serviceability. The canula shall show a smooth finished outer surface free from pits and tool marks, and inner surface free from scale, deep pits, deep furrows, or die marks; the lumen of the canula and the hub cavity shall be free from chips, dirt, or other foreign matter. Needles shall be sharp and straight, not blunt or bent, and points shall be free of feathered edges, burrs, or other defects, when examined under seven (7) power magnification.
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. Corrosion Resistance:
220.127.116.11. Canula: The canula shall withstand immersion in ten percent (10%) citric acid at room temperature for five (5) hours and after removal from the acid, boiling for 30 minutes in distilled water at room temperature for 48 hours, without showing appreciable corrosion after frying by evaporation. A glass vessel shall be used for the test.
18.104.22.168. Hub: The hub shall stand boiling for 30 minutes and remain immersed for 24 hours in distilled water without showing appreciable corrosion, or other signs of deterioration. Test to be made in a glass vessel.
6.1.2. Security of Canula in Hub: The security of the canula in the hub shall be such that the canula will stand for one (1) minute without pulling out of the hub when the number of pounds pull indicated in Table 3, Tests, Column 8, is applied to the canula.
6.1.3. Stiffness of Canula: The stiffness shall be such that the canula lying across test edges, separated by distances (in inches) indicated in Table 3, Tests, Column 4, and subjected to bending loads (in ounces) applied in the middle of the span, as shown in Table 3, Tests, Column 2, shall not bend more than the distance (in inches) indicated in Table 3, Tests, Column 3.
6.1.4. Elasticity of Canula: The elasticity shall be such that with the distal end of the canula in a fixed position, the canula (with the contact point located as in Table 3, Tests, Column 6) after bending a fixed number of degrees to one side as in Table 3, Tests, Column 5 and after being released, shall show no permanent set, i.e., shall return fully to its original shape with no evidence of distortion.
6.1.5. Resistance of Canula to Breakage: The resistance to breakage shall be such that with the distal end of the canula in a fixed position, the canula (with the contact point located as in Table 3, Tests, Column 6), shall not break when bent 20 times at the number of degrees from vertical indicated in Table 3, Tests, Column 2.
6.1.6. Sterility: The sterility test shall be performed under Sterility Tests in the current edition of United State Pharmacopoeia.
6.1.7. Freedom from Pyrogen: Place ten (10) needles in a sterile, pyrogen-free flask, pour 250 mls of sterile, pyrogen-free saline test solution (U.S.P.) into the flask and heat at not less than 85 °C for one (1) hour. The resulting saline extract shall be submitted to the "Pyrogen Test" as described in the current edition of United States Pharmacopoeia.
6.1.8. Safety Tests:
22.214.171.124. Needles with Plastic Hubs: Cover 20 needles with 30 mls of sterile, pyrogen-free saline test solution (U.S.P.) and heat at not less than 85 °C for one (1) hour. Decant the saline solution, inject 1.0 ml. of the eluate intravenously into each of 10 non-fasted, healthy, 28 to 32 gram mice. Observe the animals at 4, 24, and 72 hours after injection for any deaths or discernible symptoms of acute toxicity.
126.96.36.199. Needles with Metal Hubs: Cover 10 needles with 50 ml. of the saline test solution and boil for four (4) hours, then proceed as outline in the previous test, 188.8.131.52.
6.1.9. Resistance to Autoclaving: The needle assembly and protector shall be subject to autoclave sterilization for 20 minutes at 250 °F, under steam pressure. At the end of such time, there shall be no indications of deterioration or distortion of the canula protector or hub, or loosening of the canula within the hub.
6.1.10. Cleanliness of Inside Diameter: Visual examination of the hub with a hand lens shall not reveal any foreign matter, chips or burrs. The hub shall be cleaned with a dry cotton swab and shall be examined with a hand lens (seven (7) magnification) for burrs or foreign matter.
6.1.11. Silicone Test: Canula is pushed through a thin rubber diaphragm and evidence of the coating shall be apparent by the reduction in drag with compared with an uncoated needle.
|Gauge||Stiffness:||Stiffness:||Stiffness:||Elasticity:||Contact:||Breakage:||Security of Canula Hub:|
|Separation of test edges
|Shall bend without permanent set (degrees)||Distance from distal end of Canula (inch)||Shall bend 20 times without bending, no. of degrees both sides of vertical||Pull to be applied for one minute
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 needle assembly shall be individually and securely packaged (See Paragraph 4.4.6.) in a suitable container to maintain sterility of the 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 needle assembly and/or container or package shall be marked or labeled with the applicable commercial description including gauge and length of needle, lot or control number, manufacturer's name or trademark and the following three terms: (1) Sterile; (2) Non-Pyrogenic or Pyrogen-Free; and (3) Disposable or equivalent to denote one time use only. These three 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 (475-82-02A).
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:
11.1. The number of this specification (475-82-02).
11.2. Quantity of each:
11.2.1. Gauge (See Paragraph 4.1.).
11.2.2. Length (See Paragraph 4.1.).
11.2.3. Point Style (See Paragraph 4.2.).
Note: Unit of measure for quantity desired must be stated as each. Do not specify cartons or cases containing given quantities.
12. AVAILABILITY OF SPECIFICATIONS: Copies of this specification may be obtained by calling or writing:
Texas Procurement and Support Services
Austin, TX 78711-3047