ISO 7864 Sterile Hypodermic Needles for Single Use - Requirements and Test Methods

A European standard, "ISO 7864 Sterile hypodermic needles for single use - Requirements and test methods", describes the requirements for sterile hypodermic needles for single use in specified metric sizes from 0,18 mm to 1,2 mm. Devices that are within the scope of their own standards, such as dental needles and pen needles, are outside the scope of this standard.

For the purposes of this standard, the following terms and definitions apply:

• A gauge corresponds to a specified metric dimension that defines the limits for outside diameters.
• Unit packaging refers to the packaging of a single device designed to maintain its sterility.
• User packaging refers to packaging containing one or more unit packaging elements designed to provide labeling information to the user.
• A needle cap is a cover designed to physically protect the needle tube before use.
• A tapered needle is a needle with a tapered needle tube having an outside diameter encompassing at least two consecutive specified metric dimensions.

The requirements in this standard are specified as follows:

• General: Testing of finished products should be done on sterilized products.
• Statistics and repeatability of test methods: Any suitable test system can be used as long as the required accuracy (calibration) and precision (measurement repeatability) can be achieved.
• Cleanliness: When examined with normal or corrected-to-normal vision without magnification under illumination of 300 lx to 700 lx, the surface of the hypodermic needle tube should appear free of particles and foreign matter. When examined under 2,5x magnification, the hub (fluid pathway surface) should appear free of particles and foreign matter.
• Limits of acidity or alkalinity: When determined using a laboratory pH meter and a general-purpose electrode, the pH of an extract prepared in accordance with the annex of this standard should be within one unit of the pH of the control liquid.
• Limits for extractable metals: When tested by a recognised microanalytical method, e.g. the atomic absorption method, an extract prepared in accordance with this annex shall not contain more than 5 mg/l of lead, tin, zinc and iron in total, when corrected for the metal content of the control fluid. The cadmium content of the extract shall be less than 0,1 mg/l, when corrected for the cadmium content of the control fluid.
• Size definition - Tube needle: The size of the hypodermic needle is defined as:
  • The specified metric size of the needle tube can also be expressed in millimeters. Considering the regional distribution of products, the needle size is optionally expressed as the gauge size.
  • The nominal length of the needle tube is expressed in millimeters.
  • Optionally, the wall thickness of the needle is expressed as normal wall, thin wall, extra thin wall or ultra thin wall.
• Dimension description - Tapered needle: Details required for the user to identify the needle, including the specified metric size, shall be provided in accordance with the expression: tip/hub) × L. Where tip is the specified metric size of the needle tube at the first full diameter from the tip, expressed in millimetres. Hub is the specified metric size of the needle tube at the hub side, measured at the first full diameter from the top of the hub or the top of the mating medium, if used, and expressed in millimetres. L is the nominal length of the needle tube, expressed in millimetres.
• Colour coding: The designated metric size of hypodermic tubular needles or the first full diameter from the tip of a tapered needle is identified by colour coding in accordance with ISO standard 6009 applied to the unit packaging or to a part of the needle assembly such as the needle hub or needle cap.
• Needle hub: The conical socket of the hypodermic needle hub shall meet the requirements of ISO 80369-1, ISO 594-1 and ISO 594-2. The 80369-7 standard replaces ISO 594-1 and ISO 594-2. The hub shall be made of pigmented or unpigmented material. If pigmented, the colour shall be in accordance with ISO 6009.
• Needle cap: If a separate needle cap is provided, it must be made of pigmented or non-pigmented material. If pigmented, the colour must be in accordance with ISO 6009.
• Needle tube: According to the tube needle definition, needles must comply with the ISO 9626 standard. For tapered needles, manufacturers must define how to perform functional tests, in particular hardness and resistance to breakage, based on a specific risk assessment conducted in accordance with the ISO 14971 standard. The actual length of the needle tube must be equal to the nominal length within the tolerances given in the table. The external surface of the tube must be smooth and free from defects when examined with normal or corrected-normal vision without magnification under illumination of 300 lx to 700 lx. If the hypodermic needle tube is lubricated, the lubricant should not be visible as liquid droplets on the external or internal surfaces of the needle tube under normal or corrected vision. The amount of lubricant used should not exceed 0,25 mg/cm2 of the lubricated surface area of ​​the needle tube.

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