EUROLAB laboratory provides testing and compliance services within the scope of EN ISO 7864 standard. This International Standard covers disposable sterile hypodermic needles designed primarily for injecting or withdrawing fluids from the human body.
The plastic materials to be used in making the needles are not specified, as their selection will depend to some extent on the design, manufacturing process and sterilization method used by the individual manufacturers. The hypodermic needles specified in this International Standard are designed for use with syringes with a 80369% Luer taper connection as specified in ISO 1-80369 in conjunction with ISO 20-80369 and ISO 7-6.
EN ISO 7864 Standard Scope
This International Standard specifies requirements for sterile hypodermic needles for single use of metric sizes specified from 0,18 mm to 1,2 mm. It does not apply to devices covered by its own standard, such as dental needles and pen needles.
EN ISO 7864 for disposable hypodermic needles and cleaning, acidity and alkalinity limits, limits for removable metals, size definition, length tolerances, imperfections, lubricants, needle point, bond between hub and needle tube, lumen clearance, primary and secondary container packaging handles tests.
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EUROLABreporting and certification activities, United Accreditation Foundation (UAF), Turkish Accreditation Agency (TÜRKAK) ve Enterprise Accreditation Foundation (EAF) based on the accreditation provided by the accreditation body. The Enterprise Accreditation Foundation (EAF) accreditation body is also a signatory of the United Nations (UN GLOBAL COMPACT) organization.
