ISO standard for sterile single-use syringes for insulin
In April NEN-EN-ISO 8537:2016 was published providing performance and testing requirements for sterile single-use syringes, with or without needle, for insulin. The standard applies to 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. It covers syringes intended for single-use only in humans and with insulins of various concentrations.
The insulin syringes are intended for use immediately after filling and are not intended to contain insulin for extended periods of time (World Packaging Standardisation Newsletter, July 2016).
Click here for more information about NEN-EN-ISO 8537:2016.
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