ISO 7864 – Single Use Sterile Hypodermic Needles

Description

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

It 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 this ISO Standard  ?

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)

*** Before conducting this ISO standard  , it is important to read the entire specification. Standards can be obtained from appropriate standard authorities.

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  that are accurate and repeatable

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