BS EN ISO 7886-4-2019 PDF

Full title and description

BS EN ISO 7886-4:2019 — Sterile hypodermic syringes for single use. Part 4: Syringes with re‑use prevention feature. This British/European adoption of the international standard specifies requirements and test methods for single‑use plastic/rubber hypodermic syringes that are designed to be rendered unusable after a single use to prevent reuse.

Abstract

This standard sets out the essential design, materials and performance requirements, and specific test methods, for sterile single‑use hypodermic syringes incorporating a re‑use prevention (RUP) feature. It applies to syringes with or without needles intended for aspiration or injection immediately after filling and defines tests to verify that the device becomes unusable after normal use. It excludes glass syringes, pre‑filled syringes, and certain auto‑disable syringes covered by other parts of ISO 7886.

General information

• Status: Current / published
• Publication date: 15 May 2019 (EN adoption of ISO 7886‑4:2018)
• Publisher: British Standards Institution (BSI) — identical to EN ISO 7886‑4:2019 and ISO 7886‑4:2018
• ICS / categories: 11.040.25 (Syringes, needles and catheters)
• Edition / version: BS EN ISO 7886‑4:2019 (corresponds to ISO 7886‑4:2018, 2nd edition)
• Number of pages: ~20 pages (publication varies slightly by publisher)

Scope

This document specifies requirements for sterile single‑use hypodermic syringes made of plastic and rubber materials, with or without needle, intended for aspiration of fluids or for injection of fluids immediately after filling, and having a design such that the syringe can be rendered unusable after use (re‑use prevention). It does not apply to syringes made of glass, to syringes designed to be pre‑filled, nor to auto‑disable syringes intended for fixed‑dose immunization covered by ISO 7886‑3. The standard does not address compatibility with injectable fluids or the broader safety requirements aimed solely at reducing needle‑stick injuries (unless those devices also incorporate RUP functionality covered here).

Key topics and requirements

• Definitions and classification of syringes incorporating re‑use prevention (RUP) features.
• Material and construction requirements for plastic and rubber components used in RUP syringes.
• Design criteria that ensure the device becomes unusable after a single normal use (mechanical/functional disablement).
• Dimensional and marking requirements where applicable (capacity, graduations, identification).
• Performance tests and acceptance criteria, including tests for leakage, plunger performance, dead space, and verification of the RUP mechanism.
• Labelling and instructions for use required to identify single‑use and RUP properties, and to give safe handling instructions.
• Exclusions and normative references to other parts of ISO 7886 and relevant standards for needles, fittings, and sterilization.

Typical use and users

Manufacturers and designers of single‑use syringes with re‑use prevention mechanisms use this standard to design, test and demonstrate compliance of products for markets that adopt EN/ISO standards. Regulatory bodies, notified bodies and conformity assessment laboratories use it when assessing medical device compliance. Procurement teams in healthcare providers and international health programmes may reference it when specifying disposable syringes intended to prevent reuse. Test laboratories perform the specified tests to verify performance.

Related standards

Key related documents include other parts of the ISO 7886 series (for example ISO 7886‑1 — general requirements and test methods; ISO 7886‑2 — graduated syringes; ISO 7886‑3 — auto‑disable syringes for fixed‑dose immunization), and standards covering needles, luer fittings and device sterility/packaging. National implementations and EN adoptions mirror the ISO text as EN ISO 7886‑4:2019.

Keywords

hypodermic syringe, single‑use syringe, re‑use prevention, RUP, auto‑disable, medical device, injection, aspiration, performance tests, syringes standard, ISO 7886

FAQ

Q: What is this standard?

A: BS EN ISO 7886‑4:2019 is the British/European adoption of the ISO standard that specifies requirements and test methods for sterile single‑use hypodermic syringes equipped with a mechanism to prevent reuse after initial use.

Q: What does it cover?

A: It covers design, material and performance requirements and test methods to verify that a plastic/rubber syringe (with or without needle) is rendered unusable after normal use. It also covers labelling and marking requirements related to single‑use and RUP features.

Q: Who typically uses it?

A: Syringe manufacturers and product designers, conformity assessment and test laboratories, regulatory reviewers, and healthcare procurement teams who need to specify or assess syringes with re‑use prevention features.

Q: Is it current or superseded?

A: The document is the EN adoption of ISO 7886‑4 published in 2018 (EN/BS publication in 2019). Users should check national publication catalogs for any later confirmations or revisions, but BS EN ISO 7886‑4:2019 is the current published edition of this part of the series.

Q: Is it part of a series?

A: Yes. It is one part of the ISO 7886 series on sterile hypodermic syringes for single use. Other parts address general requirements and test methods, graduated syringes, and auto‑disable syringes for immunization programmes.

Q: What are the key keywords?

A: Hypodermic syringe, single‑use, re‑use prevention, auto‑disable, medical device testing, syringe performance, ISO 7886.