Reference number
ISO 8537:2016
International Standard
ISO 8537:2016
Sterile single-use syringes, with or without needle, for insulin
Edition 3
2016-03
Read sample
ISO 8537:2016
60510
Published (Edition 3, 2016)
This publication was last reviewed and confirmed in 2021. Therefore this version remains current.

ISO 8537:2016

ISO 8537:2016
60510
Language
Format
CHF 151
Convert Swiss francs (CHF) to your currency

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).

General information

  •  : Published
     : 2016-03
    : International Standard to be revised [90.92]
  •  : 3
     : 27
  • ISO/TC 84
    11.040.25 
  • RSS updates

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

Got a question?

Check out our Help and Support