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

SS-EN-ISO-8537 - 2016 EDITION - CURRENT
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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 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).

To find similar documents by classification:

11.040.20 (Transfusion, infusion and injection equipment Including blood packs Syringes, needles and catheters, see 11.040.25)

11.040.25 (Syringes, needles and catheters)


Medical devices

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Designation Name

SS-EN ISO 8537:2016

Revision Level

2016 EDITION

Status

Current

Publication Date

April 18, 2016

Language(s)

English

Page Count

48

International Equivalent

EN ISO 8537:2016(IDT); ISO 8537:2016(IDT)