ISO 7886-1:2017
Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
ISO 7886-1:2017 specifies requirements and test methods for verifying the design of empty sterile single-use hypodermic syringes, with or without needle, made of plastic or other materials and intended for the aspiration and injection of fluids after filling by the end-users. This document does not provide requirements for lot release. The syringes are primarily for use in humans.
Sterile syringes specified in this document are intended for use immediately after filling and are not intended to contain the medicament for extended periods of time.
It excludes syringes for use with insulin (see ISO 8537), single-use syringes made of glass, syringes for use with power-driven syringe pumps, syringes pre-filled by the manufacturer, and syringes intended to be stored after filling (e.g. in a kit for filling by a pharmacist).
Hypodermic syringes without a needle specified in this document are intended for use with hypodermic needles specified in ISO 7864.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Nomenclature
5 General requirements
6 Extraneous matter
6.1 General
6.2 Limits for acidity or alkalinity
6.3 Limits for extractable metals
7 Lubricant
8 Tolerance on graduated capacity
9 Graduated scale
9.1 Scale
9.2 Numbering of scales
9.3 Overall length of scale to nominal capacity line
9.4 Position of scale
10 Barrel
10.1 Dimensions
10.2 Barrel flanges
11 Plunger stopper/plunger assembly
11.1 Design
12 Nozzle
12.1 Conical fitting
12.2 Position of nozzle on end of barrel
12.3 Nozzle lumen
13 Performance
13.1 Dead space
13.2 Freedom from air and liquid leakage past plunger stopper
13.3 Force to operate the piston
13.4 Fit of plunger stopper/plunger in barrel
14 Packaging
14.1 Unit packaging and self-contained syringe units
14.1.1 Unit packaging
14.1.2 Self-contained syringe units
14.2 Multiple unit pack
14.3 User packaging
15 Information supplied by the manufacturer
15.1 General
15.2 Syringes
15.2.1 General
15.2.2 Additional marking for self-contained syringe units
15.3 Unit packaging
15.4 Multiple unit packs
15.4.1 General
15.4.2 Multiple unit packs with self-contained syringes
15.5 User packaging
15.6 Storage container
15.7 Transport wrapping
Annex A (normative) Method for preparation of extracts
Annex B (normative) Test method for air leakage past syringe plunger stopper during aspiration, and for separation of plunger stopper and plunger
Annex C (normative) Method for determination of dead space
Annex D (normative) Test method for liquid leakage at syringe plunger stopper under compression
Annex E (informative) Test method for the determination of forces required to operate the piston
Annex F (informative) Test method for the quantity of silicone
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Nomenclature
5 General requirements
6 Extraneous matter
6.1 General
6.2 Limits for acidity or alkalinity
6.3 Limits for extractable metals
7 Lubricant
8 Tolerance on graduated capacity
9 Graduated scale
9.1 Scale
9.2 Numbering of scales
9.3 Overall length of scale to nominal capacity line
9.4 Position of scale
10 Barrel
10.1 Dimensions
10.2 Barrel flanges
11 Plunger stopper/plunger assembly
11.1 Design
12 Nozzle
12.1 Conical fitting
12.2 Position of nozzle on end of barrel
12.3 Nozzle lumen
13 Performance
13.1 Dead space
13.2 Freedom from air and liquid leakage past plunger stopper
13.3 Force to operate the piston
13.4 Fit of plunger stopper/plunger in barrel
14 Packaging
14.1 Unit packaging and self-contained syringe units
14.1.1 Unit packaging
14.1.2 Self-contained syringe units
14.2 Multiple unit pack
14.3 User packaging
15 Information supplied by the manufacturer
15.1 General
15.2 Syringes
15.2.1 General
15.2.2 Additional marking for self-contained syringe units
15.3 Unit packaging
15.4 Multiple unit packs
15.4.1 General
15.4.2 Multiple unit packs with self-contained syringes
15.5 User packaging
15.6 Storage container
15.7 Transport wrapping
Annex A (normative) Method for preparation of extracts
Annex B (normative) Test method for air leakage past syringe plunger stopper during aspiration, and for separation of plunger stopper and plunger
Annex C (normative) Method for determination of dead space
Annex D (normative) Test method for liquid leakage at syringe plunger stopper under compression
Annex E (informative) Test method for the determination of forces required to operate the piston
Annex F (informative) Test method for the quantity of silicone
Bibliography