BS EN 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.

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).


Cross References:
ISO 594-1
ISO 3696
ISO 7864
ISO 9626
ISO 10993-1
ISO 11608?1
ISO 11608?5
ISO 14971
ISO 15223-1:2012
ISO 23908
ISO/IEC 80369-7
IEC 62366-1
ISO 81714-1
ISO 15223-2
93/42/EEC
2007/47/EEC


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