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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Sisällysluettelo
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
15.2 Multiple unit pack
15.3 User packaging
16 Information supplied by the manufacturer
16.1 General
16.2 Syringes
16.3 Unit packaging
16.4 Multiple unit packs
16.5 User packaging
16.6 Storage container
16.7 Transport wrapping
Annex A Short-term flow rate accuracy (normative)
Annex B Pump force (informative)
Annex C Determination of syringe compliance (normative)
ISO 3696:1987 Water for analytical laboratory use -- Specification and test methods
ISO 7886-1:2017 Sterile hypodermic syringes for single use -- Part 1: Syringes for manual use
ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications -- Part 7: Connectors for intravascular or hypodermic applications
ISO 3696:1987 Water for analytical laboratory use -- Specification and test methods
ISO 7886-1:2017 Sterile hypodermic syringes for single use -- Part 1: Syringes for manual use
ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications -- Part 7: Connectors for intravascular or hypodermic applications
ISO/IEC Guide 99:2007 International vocabulary of metrology -- Basic and general concepts and associated terms (VIM)