ISO 8537:2016

Sterile single-use syringes, with or without needle, for insulin

Publication date: 21 mar 2016

General information

Current stage: 90.92 Effective date: 5 gush 2024

Originator: ISO

Owner: ISO/TC 84

Type: International Standard

ICS: 11.040.25

Gjuha: anglisht frëngjisht

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Statusi: Publikuar

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Scope

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).