SIST EN ISO 7885:2010 PDF

Overview

EN ISO 7885:2010 (ISO 7885:2010) defines requirements for sterile injection needles for single use used with dental cartridge syringes (see ISO 9997) for delivery of local anaesthetics. The standard covers dimensional and performance requirements, packaging, labelling and colour coding for routine dental injection needles. It does not cover needles for special techniques. Only the materials used for the needle tubing are specified.

Key topics and technical requirements

• Needle tubing material: must comply with ISO 9626 (stainless steel needle tubing).
• Nominal outside diameter: between 0.2 mm and 0.5 mm (sizes designated in mm, e.g. 0.4 mm × 34 mm).
• Effective needle length: manufacturer-stated length ±10%.
• Butt end: angle 15°–55°; butt-end length 9.0–14.0 mm.
• Needle tip quality: pointed and, at ×2.5 magnification, free from feather edges, burrs or hooks; primary bevel angle within 2° of manufacturer’s specification.
• Hub and union strength: hub–needle union must not break under ≥22 N applied along the needle axis. Socket depth of hub ≥ 5 mm. Threaded hubs must fit metric M6 × 0.75; unthreaded hubs must attach securely to ISO 9997 cartridge syringes. Imperial thread guidance is provided in an informative annex.
• Colour coding: nominal diameters identified per ISO 6009 - 0.2 black, 0.25 white, 0.3 yellow, 0.4 medium grey, 0.5 orange. Colour may appear on primary container or hub.
• Packaging (primary container): must maintain sterility, show evidence of opening, and allow the effective needle sheath to assist attachment without touching the needle (hardpack or softpack designs).
• Sterility and labelling: needles must undergo a validated sterilization process. Labels must include manufacturer, size, thread type, “Sterile injection needle for single-use”, single-use symbol, expiry/use-by date (ISO 8601), sterilization method, lot number and unit counts.

Applications and users

• Intended for dental clinicians, dental product manufacturers, quality and regulatory teams, procurement officers, and test laboratories involved with dental injection needles and cartridge syringe systems.
• Used to ensure compatibility, safety and traceability for single‑use dental needles in routine local anaesthesia. Also informs design, manufacturing controls, packaging and labelling for CE/ISO compliance.

Related standards

• ISO 9997 (dental cartridge syringes)
• ISO 9626 (stainless steel needle tubing)
• ISO 6009 (colour coding for hypodermic needles)
• ISO 7864 (sterile hypodermic needles for single use)
• ISO 15223-1, ISO 10993-1/11 and ISO 7405 (labelling and biocompatibility guidance)
• ISO sterilization standards (ISO 11135, ISO 11137, ISO 17665)

Keywords: EN ISO 7885, ISO 7885:2010, dentistry sterile injection needles single use, dental cartridge syringes, needle dimensions, hub compatibility, packaging labelling colour coding.