Sterile single-use syringes, with or without needle, for insulin
Abstract
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).
Begin
2024-08-10
WI
00205411
Planned document number
DIN EN ISO 8537 rev
Project number
17600119
Responsible national committee
NA 176-04-02 AA - Injection systems
Responsible european committee
CEN/TC 205 - Non-active medical devices
