NEN EN ISO 8537 : 2016

Committees responsible
National foreword
Introduction
Specification
1. Scope
2. Normative references
3. Definitions and nomenclature
4. Types of syringe
5. Freedom from extraneous matter
6. Limits for extractable matter
7. Lubrication of syringes and needles
8. Range of sizes
9. Graduated scale
10. Barrel
11. Piston/plunger assembly
12. Nozzle
13. Needles
14. Performance of assembled syringe
15. Packaging
16. Marking
Annexes
A. Fluid for determination of acidity/alkalinity and
     extractable metals
B. Test method for air leakage past syringe piston
     during aspiration
C. Test method for force required to operate plunger
D. Properties of needles with external diameter less
     than 0,45 mm
E. Test method for determination of dead space
F. Test method for liquid leakage at syringe piston
     and syringe nozzle/hub or needle/barrel unions
     during compression
G. Test method for air leakage past nozzle/hub or
     needle/barrel unions during aspiration
H. Preparation of extract for test for pyrogenicity
     and toxicity
J. Symbol for 'do not re-use'
Tables
1. Insulin syringes, range of sizes, graduated scale
     and tolerance on graduated capacity
2. Maximum dead space
D.1 Diameter of needle tube
D.2 Stiffness
D.3 Minimum strength of bond between hub/syringe and
     needle tube
D.4 Size of stylet to test patency of lumen
D.5 Resistance to breakage
Figures
1. Schematic representation of insulin syringe for
     single use
B.1 Apparatus used in aspiration tests
J.1 ISO symbol for single use, number ISO 7000/1051

Defines requirements and test methods for empty, sterile, single-use syringes, with or without needles, made of plastic materials and intended solely for the injection of insulin, with which the syringes are filled by the end user.