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Project

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

2024-08-06

WI

00205411

Planned document number

prEN ISO 8537 rev

Responsible national committee

NA 176-04-02 AA - Injection systems  

Responsible european committee

CEN/TC 205 - Non-active medical devices  

previous edition(s)

Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016)
2016-04

Order from DIN Media

Contact

Dipl.-Ing. (FH)

Björn Hermes

Am DIN-Platz, Burggrafenstr. 6
10787 Berlin

Tel.: +49 30 2601-2404
Fax: +49 30 2601-42404

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