ISO 7886-4-2018 PDF

Full title and description

ISO 7886-4:2018 — Sterile hypodermic syringes for single use — Part 4: Syringes with re‑use prevention feature. This International Standard specifies requirements and test methods for sterile single‑use hypodermic syringes (plastic and rubber, with or without needle) that are designed to be rendered unusable after a single use to prevent reuse and reduce the risk of blood‑borne pathogen transmission.

Abstract

Defines design, material, performance, packaging and information requirements for syringes incorporating a re‑use prevention mechanism. The document excludes glass syringes, auto‑disable syringes for fixed‑dose immunization and pre‑filled syringes, and does not address fluid compatibility or needle‑stick protection as primary topics. Normative and informative test methods for the re‑use prevention feature and extract preparation are included.

General information

• Status: Published.
• Publication date: November 2018 (Edition 2; published 2018‑11).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.25 (Syringes, needles and catheters).
• Edition / version: 2 (2018).
• Number of pages: 10.

Scope

Applies to sterile single‑use hypodermic syringes made of plastic and rubber materials, with or without an attached needle, intended for aspiration or for injection immediately after filling and designed to be rendered unusable after one use. Excludes syringes made of glass, auto‑disable syringes for fixed‑dose immunization (covered by ISO 7886‑3) and syringes designed to be pre‑filled; compatibility with injection fluids is not addressed.

Key topics and requirements

• Classification and types of re‑use prevention mechanisms (designs that prevent re‑use either automatically or by activation on first use).
• Material, cleanliness and extractables requirements (limits on extraneous matter and extractable metals; extract preparation described in an annex).
• Design and dimensional requirements for barrel, plunger/stopper, graduations and nozzle/needle interfaces.
• Performance tests including dead space, air and liquid leakage, resistance and verification of the re‑use prevention feature (normative test methods provided).
• Packaging, labelling and information supplied by the manufacturer (unit packaging, storage/transport considerations and required markings).
• Normative references and cross‑references to related syringe and needle standards for complementary requirements and testing.

Typical use and users

Used by medical device manufacturers (design and quality teams) developing single‑use syringes with built‑in re‑use prevention; by test laboratories performing performance and extract testing; by regulatory and conformity assessment bodies reviewing device documentation; and by healthcare procurement and infection control teams selecting devices to reduce reuse risk in clinical settings.

Related standards

ISO 7886 is a multi‑part series. Closely related parts and documents include ISO 7886‑1 (syringes for manual use), ISO 7886‑2 (syringes for use with power‑driven syringe pumps) and ISO 7886‑3 (auto‑disable syringes for fixed‑dose immunization). Other related standards address needles, insulin syringes and sterilization/test methods referenced in normative clauses. The ISO standard has also been adopted as EN ISO 7886‑4 (European adoption / BSI national publication).

Keywords

hypodermic syringe, single‑use syringe, re‑use prevention, auto‑disable, syringe performance, extractables, leakage test, medical device standard, ISO 7886.

FAQ

Q: What is this standard?

A: ISO 7886‑4:2018 is the ISO International Standard specifying requirements and test methods for sterile single‑use hypodermic syringes that include a built‑in re‑use prevention feature to ensure the syringe becomes unusable after one use.

Q: What does it cover?

A: It covers design, materials, cleanliness, dimensional and performance requirements, tests for leakage and dead space, verification of the re‑use prevention mechanism, packaging and labelling requirements, and normative references; it does not cover glass syringes, pre‑filled syringes or auto‑disable immunization syringes (ISO 7886‑3).

Q: Who typically uses it?

A: Manufacturers, quality and regulatory teams, test laboratories, procurement and infection control professionals, and conformity assessment bodies involved with single‑use syringe products.

Q: Is it current or superseded?

A: The 2018 second edition (ISO 7886‑4:2018) is the current published edition; the previous 2006 edition was withdrawn and replaced by the 2018 edition. The ISO record indicates the 2018 edition is published and confirmed in the ISO lifecycle.

Q: Is it part of a series?

A: Yes — ISO 7886 is a multipart series covering different syringe types and uses (for example ISO 7886‑1, ‑2 and ‑3); ISO 7886‑4 specifically addresses syringes with a re‑use prevention feature.

Q: What are the key keywords?

A: Re‑use prevention, single‑use syringe, hypodermic syringe, performance tests, extractables, leakage, ISO 7886.