EN ISO 7885:2010 PDF

Name: EN ISO 7885:2010 — Dentistry - Sterile injection needles for single use (ISO 7885:2010)
SKU: EN ISO 7885:2010
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Dentistry - Sterile injection needles for single use (ISO 7885:2010)

Название (английский):

EN ISO 7885:2010

Dentistry - Sterile injection needles for single use (ISO 7885:2010)

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 14
Дата публикации:: 15 февраля 2010 г.
Издание:: CEN EN 7885 edition 2 version 1
ICS:: 11.040.20

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Описание (английский):

ISO 7885:2010 gives dimensional and performance requirements for sterile injection needles for single use which are used in dental cartridge syringes complying with ISO 9997 for injection of dental local anaesthetics. It further specifies requirements with respect to their packaging, labelling and colour coding. It does not cover needles for special applications or techniques. Only the materials used for the construction of the needle tubing are specified.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

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.

EN ISO 7885:2010 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Applications and users

Related standards

Технические детали

ISO 7885:2010

Dentistry — Sterile injection needles for single use

SIST EN ISO 9997:2020

Dentistry - Cartridge syringes (ISO 9997:2020)

SIST EN ISO 9626:2016

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SIST EN ISO 6009:2016

Hypodermic needles for single use - Colour coding for identification (ISO 6009:2016)

ISO 8601-1:2019/Amd 1:2022

Date and time — Representations for information interchange — Part 1: Basic rules — Amendment 1: Technical co…

SIST EN ISO 7864:2016

Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016)

SIST EN ISO 15223-1:2021/A1:2026

Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General re…

ISO 10993-11:1993

Biological evaluation of medical devices — Part 11: Tests for systemic toxicity