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Number of Standard: | CSN EN ISO 8537 |
Category: | 856172 |
Pages: | 44 |
Released: | 01.10.2016 |
Catalog number: | 500393 |
DESCRIPTION
CSN EN ISO 8537
CSN EN ISO 8537 This International Standard 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. This International Standard excludes single-use syringes made of glass, syringes for use with powerdriven 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).
Original English text of CSN EN Standard.
The price of the Standard included all amendments and correcturs.