ISO 7886-4:2018 PDF

Sterile hypodermic syringes for single use — Part 4: Syringes with re-use prevention feature

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Title (English):

ISO 7886-4:2018

Sterile hypodermic syringes for single use — Part 4: Syringes with re-use prevention feature

Document status:: Active
Format:: Electronic (PDF)
Number of pages:: 10
Publication date:: November 15, 2018
Edition:: ISO IS 7886 edition 2 version 1
ICS:: 11.040.25

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Description (English):

This document specifies requirements for sterile single-use hypodermic syringes made of plastic and rubber materials with or without needle, and intended for the aspiration of fluids or for the injection of fluids immediately after filling and of design such that the syringe can be rendered unusable after use. This document is not applicable to syringes made of glass [specified in ISO 595 (withdrawn)], auto-disable syringes for fixed dose immunization (ISO 7886‑3) and syringes designed to be pre-filled. It does not address compatibility with injection fluids. Other standards can be applicable when syringes are used for any other intended purpose than those specified in this document. NOTE Syringes designed to reduce the risk of needle-stick injuries can also comply with this document with regard to their re-use prevention properties, but it is stressed that anti-needle-stick properties of syringes are not in themselves addressed in this document.

Technical details

Technical committee: ISO/TC 84 - Devices for administration of medicinal products and catheters
SKU: ISO 7886-4:2018

Abstract

Overview

ISO 7886-4:2018 - "Sterile hypodermic syringes for single use - Part 4: Syringes with re‑use prevention feature" specifies requirements for sterile, single‑use plastic and rubber hypodermic syringes (with or without needle) designed to be rendered unusable after one use. The standard targets syringes intended for aspiration or immediate injection and focuses on preventing intentional or accidental reuse to reduce transmission of blood‑borne pathogens. It is the second edition (2018) and aligns terminology and testing with other ISO 7886 parts.

Key topics and technical requirements

This part of ISO 7886 covers technical and performance aspects relevant to re‑use prevention and general syringe safety:

Scope and exclusions: applies to single‑use plastic/rubber syringes; excludes glass syringes, ISO 7886‑3 auto‑disable syringes for fixed‑dose immunization, and pre‑filled syringes. It does not address compatibility with injection fluids or needle‑stick protection per se.
Types and function: classification of syringes by type of re‑use prevention feature (including automatic or activation‑based mechanisms) and intended clinical applications.
Materials and cleanliness: requirements on extraneous matter, extractables (metals), and lubricants to ensure sterility and safety.
Design and dimensions: specifications for graduated scale, barrel and flange dimensions, plunger/stoppers, nozzle and needle interfaces.
Performance tests: dead space, leakage (air and liquid), resistance to reuse, and post‑shipping performance. Annex B provides a normative test method for the re‑use prevention feature; Annex A covers extract preparation.
Packaging and labeling: unit and multiple‑unit packaging, user packaging, storage and transport wrapping, and detailed information to be supplied by the manufacturer.
Normative references: cross‑references to related standards (e.g., ISO 7886‑1, ISO 7864, ISO 8537) and relevant test methods.

Applications and users

ISO 7886‑4 is intended for:

Medical device manufacturers designing and producing single‑use syringes with built‑in re‑use prevention features.
Quality assurance and regulatory teams responsible for device conformity, testing and documentation.
Procurement and healthcare organizations selecting syringes to minimize reuse and infection risk.
Testing laboratories performing performance and extraction tests according to the Annexes.

Practical benefits include improved infection control, clear conformity criteria for safety‑engineered syringes, and harmonized test methods for product acceptance.

Related standards

ISO 7886‑1:2017 – Syringes for manual use (general requirements)
ISO 7886‑3 – Auto‑disable syringes for fixed‑dose immunization
ISO 7864:2016 – Sterile hypodermic needles for single use
ISO 8537:2016, ISO 3696, ISO 9626 and relevant ASTM shipping/drop test methods

For implementation or certification, consult the full ISO 7886‑4:2018 text available from ISO or your national standards body.

Related standards

Standards mentioned in the description

Abstract

Overview

Key topics and technical requirements

This part of ISO 7886 covers technical and performance aspects relevant to re‑use prevention and general syringe safety:

Scope and exclusions: applies to single‑use plastic/rubber syringes; excludes glass syringes, ISO 7886‑3 auto‑disable syringes for fixed‑dose immunization, and pre‑filled syringes. It does not address compatibility with injection fluids or needle‑stick protection per se.
Types and function: classification of syringes by type of re‑use prevention feature (including automatic or activation‑based mechanisms) and intended clinical applications.
Materials and cleanliness: requirements on extraneous matter, extractables (metals), and lubricants to ensure sterility and safety.
Design and dimensions: specifications for graduated scale, barrel and flange dimensions, plunger/stoppers, nozzle and needle interfaces.
Performance tests: dead space, leakage (air and liquid), resistance to reuse, and post‑shipping performance. Annex B provides a normative test method for the re‑use prevention feature; Annex A covers extract preparation.
Packaging and labeling: unit and multiple‑unit packaging, user packaging, storage and transport wrapping, and detailed information to be supplied by the manufacturer.
Normative references: cross‑references to related standards (e.g., ISO 7886‑1, ISO 7864, ISO 8537) and relevant test methods.

Applications and users

ISO 7886‑4 is intended for:

Medical device manufacturers designing and producing single‑use syringes with built‑in re‑use prevention features.
Quality assurance and regulatory teams responsible for device conformity, testing and documentation.
Procurement and healthcare organizations selecting syringes to minimize reuse and infection risk.
Testing laboratories performing performance and extraction tests according to the Annexes.

Practical benefits include improved infection control, clear conformity criteria for safety‑engineered syringes, and harmonized test methods for product acceptance.

Related standards

ISO 7886‑1:2017 – Syringes for manual use (general requirements)
ISO 7886‑3 – Auto‑disable syringes for fixed‑dose immunization
ISO 7864:2016 – Sterile hypodermic needles for single use
ISO 8537:2016, ISO 3696, ISO 9626 and relevant ASTM shipping/drop test methods

For implementation or certification, consult the full ISO 7886‑4:2018 text available from ISO or your national standards body.

ISO 7886-4:2018 PDF

Technical details

Abstract

Overview

Key topics and technical requirements

Applications and users

Related standards

Related standards

Abstract

Overview

Key topics and technical requirements

Applications and users

Related standards

Related standards

Sterile hypodermic syringes for single use — Part 1: Syringes for manual use

Sterile hypodermic needles for single use — Requirements and test methods

Sterile single-use syringes, with or without needle, for insulin

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Sterile hypodermic syringes for single use - Part 3: Auto-disabled syringes for fixed-dose immunization (ISO…

Sterile hypodermic syringes for single use - Part 1: Syringes for manual use (ISO 7886-1:2017, Corrected vers…

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

Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016)