ISO-8537 › Sterile single-use syringes, with or without needle, for insulin
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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).
To find similar documents by classification:
11.040.25 (Syringes, needles and catheters)
To find similar documents by Federal Supply Class Code:
FSC 6515 (Medical and Surgical Instruments, Equipment, and Supplies)
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Document Number
ISO 8537:2016
Revision Level
3RD EDITION
Status
Current
Publication Date
March 15, 2016
Committee Number
ISO/TC 84