ISO 7886-4:2018
Sterile hypodermic syringes for single use — Part 4: Syringes with re-use prevention feature
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This document is not applicable to syringes made of glass [specified in ISO 595 (withdrawn)], auto-disable syringes for fixed dose immunization (ISO 7886‑3) and syringes designed to be pre-filled.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.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Types of syringe
4.1 General
4.2 Types of re-use prevention feature
4.3 Types of intended use/application
5 Extraneous matter
5.1 General
5.2 Limits for acidity or alkalinity
5.3 Limits for extractable metals
6 Lubricant
7 Tolerance on graduated capacity
8 Graduated scale
8.1 Scale
8.2 Numbering of scale
8.3 Position of scale
8.4 Overall length of scale to nominal capacity line
9 Barrel
9.1 Dimensions
9.2 Barrel flanges
10 Plunger stopper/plunger assembly
10.1 Design
10.2 Fit of plunger stopper/plunger in the barrel
10.3 Fiducial line
11 Syringe nozzle/needle
11.1 Syringe with integrated needle
11.2 Syringe with Luer nozzle
12 Performance
12.1 Dead space
12.2 Freedom from air and liquid leakage
12.3 Re-use prevention feature
12.4 Performance after shipping
13 Packaging
13.1 Unit packaging and self-contained syringe units
13.2 Multiple unit pack
13.3 User packaging
14 Information supplied by the manufacturer
14.1 General
14.2 Syringes
14.2.1 General
14.2.2 Unit packaging
14.3 Multiple unit packs
14.3.1 General
14.3.2 Multiple unit packs with self-contained syringes
14.4 User packaging
14.4.1 General
14.4.2 Storage container
14.5 Transport wrapping
Annex A (normative) Method for preparation of extracts
Annex B (normative) Test method for testing re-use prevention feature
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Types of syringe
4.1 General
4.2 Types of re-use prevention feature
4.3 Types of intended use/application
5 Extraneous matter
5.1 General
5.2 Limits for acidity or alkalinity
5.3 Limits for extractable metals
6 Lubricant
7 Tolerance on graduated capacity
8 Graduated scale
8.1 Scale
8.2 Numbering of scale
8.3 Position of scale
8.4 Overall length of scale to nominal capacity line
9 Barrel
9.1 Dimensions
9.2 Barrel flanges
10 Plunger stopper/plunger assembly
10.1 Design
10.2 Fit of plunger stopper/plunger in the barrel
10.3 Fiducial line
11 Syringe nozzle/needle
11.1 Syringe with integrated needle
11.2 Syringe with Luer nozzle
12 Performance
12.1 Dead space
12.2 Freedom from air and liquid leakage
12.3 Re-use prevention feature
12.4 Performance after shipping
13 Packaging
13.1 Unit packaging and self-contained syringe units
13.2 Multiple unit pack
13.3 User packaging
14 Information supplied by the manufacturer
14.1 General
14.2 Syringes
14.2.1 General
14.2.2 Unit packaging
14.3 Multiple unit packs
14.3.1 General
14.3.2 Multiple unit packs with self-contained syringes
14.4 User packaging
14.4.1 General
14.4.2 Storage container
14.5 Transport wrapping
Annex A (normative) Method for preparation of extracts
Annex B (normative) Test method for testing re-use prevention feature
Bibliography