Expand All
TOC Search:
ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin, 2016
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 Types of syringes
- 5 Requirements
- 5.1 General requirements
- 5.2 Material selection
- 5.3 Colour coding
- 5.4 Extraneous matter
- 5.4.1 General
- 5.4.2 Limits for acidity or alkalinity
- 5.4.3 Limits for extractable metals
- 5.5 Lubrication
- 5.5.1 Lubrication of syringes
- 5.5.2 Lubrication of needle tube
- 5.6 Dimensions
- 5.6.1 Barrel and plunger stopper
- 5.6.2 Finger grips
- 5.7 Plunger/plunger stopper
- 5.7.1 General
- 5.7.2 Fit of plunger stopper in barrel
- 5.8 Nozzle
- 5.8.1 Conical fitting
- 5.8.2 Position of nozzle on end of barrel
- 5.9 Needle tubing and needles
- 5.9.1 Needles for syringe types 3 and 4
- 5.9.2 Needle tubing for syringe types 5, 6, 7 and 8
- 5.9.3 Bond between hub and needle tube
- 5.10 Standard test environmental conditions
- 5.11 Performance of assembled syringe
- 5.11.1 Dead space
- 5.11.2 Freedom from leakage at needle
- 5.11.3 Freedom from leakage past plunger stopper
- 6 Packaging
- 6.1 Unit packaging and self-contained syringe units
- 6.1.1 General
- 6.1.2 Unit packaging providing sterile barrier syringes (types 1, 3, 5 and 7)
- 6.1.3 Self-contained syringes with sterile interiors (types 2, 4, 6 and 8)
- 6.2 Multiple-unit packaging (for syringe types 2, 4, 6 and 8)
- 6.3 User packaging
- 7 Information supplied by the manufacturer
- 7.1 General
- 7.2 Syringes
- 7.2.1 General
- 7.2.2 Additional marking for self-contained syringes (syringe types 2, 4, 6 and 8)
- 7.3 Unit packaging (for syringe types 1, 3, 5 and 7)
- 7.4 Multiple unit packs (syringe types 2, 4, 6 and 8)
- 7.5 User packaging
- 7.6 Storage container
- 7.7 Transport wrapping
- Annex A (normative) Fluid for determination of acidity/alkalinity and extractable metals
- Annex B (normative) Test method for air leakage past syringe piston during aspiration and for separation of rubber stopper and plunger
- Annex C (normative) Test method for determination of forces required to operate piston
- Annex D (normative) Test method for determination of dead space
- Annex E (normative) Test method for liquid leakage at syringe piston and syringe nozzle/hub or needle/barrel unions during compression
- Annex F (normative) Test method for air leakage past nozzle/hub or needle/barrel unions during aspiration
- Annex G (normative) Preparation of extract for test for pyrogenicity and toxicity
- Annex H (normative) Syringe sizes and graduated scales
- Bibliography [Go to Page]