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SRPS EN ISO 8537:2017

Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016)

Jan 31, 2017

General information

60.60     Jan 31, 2017



European Norm

11.040.25     11.040.20  




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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).

Related directives

Directives related to this standard.


Medical devices

Life cycle


SRPS EN ISO 8537:2011


SRPS EN ISO 8537:2017
60.60 Standard published
Jan 31, 2017

Related project

Adopted from EN ISO 8537:2016

Adopted from ISO 8537:2016