Main menu
60.60 Standard published Apr 13, 2016
CEN
CEN/TC 205 Non-active medical devices
European Norm
11.040.20 Transfusion, infusion and injection equipment
Published
ISO 8537:2016 specifies 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. This International Standard covers syringes intended for single-use only in humans and with insulins of various concentrations.
The insulin syringes specified in this International Standard are intended for use (i.e. insulin injection) immediately after filling and are not intended to contain insulin for extended periods of time.
ISO 8537:2016 excludes single-use syringes made of glass, syringes for use with power-driven syringe pumps, syringes that are pre-filled by the manufacturer, and syringes intended to be stored after filling (e.g. in a kit intended for filling by a pharmacist).
Legislation related to this standard
WITHDRAWN
EN ISO 8537:2008
PUBLISHED
EN ISO 8537:2016
60.60
Standard published
Apr 13, 2016