ISO 7886-3:2020
Sterile hypodermic syringes for single use — Part 3: Auto-disabled syringes for fixed-dose immunization
This document specifies the properties and performance of sterile single-use hypodermic syringes with an auto-disable syringe feature intended to deliver a fixed dose of vaccine immediately after filling. The syringes can be made of plastic, rubber or other materials and can be with or without needle and needle protection feature.
This document does not specify the design of the auto-disable syringe feature.
This document is not applicable to syringes for use with insulin (covered by ISO 8537), syringes for use with power-driven syringe pumps (covered by ISO 7886-2), reuse prevention syringes (covered by ISO 7886-4) or syringes designed to be prefilled (covered by the ISO 11040 series). It does not address compatibility with injection fluids/vaccines.
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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 nominal capacity
9 Graduated scale
9.1 Scale
9.2 Position of scale
10 Barrel
10.1 Dimensions
10.2 Barrel flanges
11 Plunger stopper/plunger assembly
11.1 Design
11.2 Fit of the plunger stopper/plunger in the barrel
11.3 Fiducial line
12 Needle
12.1 General
12.2 Integrated needle
12.3 Non-integrated needle
12.4 Sharps protection features
13 Performance
13.1 General
13.2 Dead space
13.3 Freedom from air and liquid leakage
13.4 Auto-disable syringe feature
13.5 Performance after shipping
14 Packaging
14.1 Unit packaging providing sterile barrier
14.2 Multiple unit pack
14.3 User packaging
15 Information supplied by the manufacturer
15.1 General
15.2 Syringes
15.3 Unit packaging providing sterile barrier
15.4 User packaging
15.5 Storage containers
15.6 Transport wrapping
Annex A (normative) Method for preparation of extracts
Annex B (informative) Test method for forces required to operate piston
Annex C (normative) Test method for testing auto-disable syringe feature
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 nominal capacity
9 Graduated scale
9.1 Scale
9.2 Position of scale
10 Barrel
10.1 Dimensions
10.2 Barrel flanges
11 Plunger stopper/plunger assembly
11.1 Design
11.2 Fit of the plunger stopper/plunger in the barrel
11.3 Fiducial line
12 Needle
12.1 General
12.2 Integrated needle
12.3 Non-integrated needle
12.4 Sharps protection features
13 Performance
13.1 General
13.2 Dead space
13.3 Freedom from air and liquid leakage
13.4 Auto-disable syringe feature
13.5 Performance after shipping
14 Packaging
14.1 Unit packaging providing sterile barrier
14.2 Multiple unit pack
14.3 User packaging
15 Information supplied by the manufacturer
15.1 General
15.2 Syringes
15.3 Unit packaging providing sterile barrier
15.4 User packaging
15.5 Storage containers
15.6 Transport wrapping
Annex A (normative) Method for preparation of extracts
Annex B (informative) Test method for forces required to operate piston
Annex C (normative) Test method for testing auto-disable syringe feature
Bibliography