ISO 7886-2:2020
Sterile hypodermic syringes for single use — Part 2: Syringes for use with power-driven syringe pumps
This document specifies requirements for sterile single-use hypodermic syringes of nominal capacity 1 ml and above, made of plastic materials and intended for use with power-driven syringe pumps.
This document does not apply to syringes with auto-disable syringe features (ISO 7886-3[2]), syringes for use with insulin (ISO 8537[3]), single-use syringes made of glass, syringes prefilled with the injection by the manufacturer and syringes supplied with the injection as a kit for filling by a pharmacist. It does not address compatibility with injection fluids.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Nomenclature
5 General requirements
6 Limits for acidity or alkalinity
7 Limits for extractable metals
8 Lubricant
9 Tolerance on graduated capacity
10 Graduated scale
11 Syringe design
12 Piston/plunger assembly
12.1 Design
12.2 Fit of plunger stopper/plunger in barrel
13 Nozzle
13.1 Conical fitting
13.2 Nozzle lumen
14 Performance
14.1 Dead space
14.2 Freedom from air and liquid leakage past the plunger stopper
14.3 Short-term flow rate error
14.4 Pump forces
14.5 Syringe compliance
15 Packaging
15.1 Unit packaging and self-contained syringe units
15.1.1 Unit packaging
15.1.2 Self-contained syringe units
15.2 Multiple unit pack
15.3 User packaging
16 Information supplied by the manufacturer
16.1 General
16.2 Syringes
16.2.1 General
16.2.2 Additional marking for self-contained syringe units
16.3 Unit packaging
16.4 Multiple unit packs
16.4.1 General
16.4.2 Multiple unit packs with self-contained syringes
16.5 User packaging
16.6 Storage container
16.7 Transport wrapping
Annex A (normative) Short-term flow rate accuracy
Annex B (informative) Pump force
Annex C (normative) Determination of syringe compliance
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Nomenclature
5 General requirements
6 Limits for acidity or alkalinity
7 Limits for extractable metals
8 Lubricant
9 Tolerance on graduated capacity
10 Graduated scale
11 Syringe design
12 Piston/plunger assembly
12.1 Design
12.2 Fit of plunger stopper/plunger in barrel
13 Nozzle
13.1 Conical fitting
13.2 Nozzle lumen
14 Performance
14.1 Dead space
14.2 Freedom from air and liquid leakage past the plunger stopper
14.3 Short-term flow rate error
14.4 Pump forces
14.5 Syringe compliance
15 Packaging
15.1 Unit packaging and self-contained syringe units
15.1.1 Unit packaging
15.1.2 Self-contained syringe units
15.2 Multiple unit pack
15.3 User packaging
16 Information supplied by the manufacturer
16.1 General
16.2 Syringes
16.2.1 General
16.2.2 Additional marking for self-contained syringe units
16.3 Unit packaging
16.4 Multiple unit packs
16.4.1 General
16.4.2 Multiple unit packs with self-contained syringes
16.5 User packaging
16.6 Storage container
16.7 Transport wrapping
Annex A (normative) Short-term flow rate accuracy
Annex B (informative) Pump force
Annex C (normative) Determination of syringe compliance
Bibliography