ISO 7864 Single-Use Sterile Hypodermic Needles

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ISO 7864 Single-Use Sterile Hypodermic Needles

ISO 7864 specifies the following requirements for needles of nominal outside diameters 0.3 mm and 1.2 mm: nomenclature for components, cleanliness, limits for acidity and alkalinity, size designation, color coding, needle hub, sheath, needle tube, needle point, performance, packaging, labeling, storage container, transport wrapping.

What test machine requirements are needed per ISO 7864?

  • Drag Force Test (ISO 7864 Annex D) the needle pierces a substrate at a constant test speed while measuring force peak and friction force
    • Constant speed of 100 mm/min (4 ipm)
    • Report peak force and drag force
  • Bonding strength test (ISO 7864 Annex E) measures the strength of the bond between the needle tube and needle hub
    • Maximum load 500 N (110 lb)
    • Constant speed of 50 mm/min (2 ipm)