BS EN ISO 8537:2016 pdf free

BS EN ISO 8537:2016 pdf free.Sterile single-use syringes, with or without needle, for insulin
BS EN ISO 8537 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.
BS EN ISO 8537 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 flling (e.g. in a kit intended for flling by a pharmacist).
The general requirements listed below are considered to be design guidelines for manufacturers.
a) Given the likelihood that multiple insulin concentrations and concentration-specific syringes will exist in a particular country or locality, the manufacturer shall develop risk mitigation strategies to minimize the occurrence of “wrong dose” medication errors.
b) The syringe shall indicate, through visual means, the insulin concentration it is intended to contain.The insulin syringes should also indicate, through non-visual means e.g. tactile), the insulin concentration it is intended to contain.
c) Syringes designed to contain a specific concentration of insulin (e.g. U-100) shall be adequately differentiated visually from other dedicated syringes. This differentiation shall be determined based on a risk assessment and confirmed through usability validation testing.
d) The syringe and needle should be free from defects affecting safety, serviceability for their intended use, and appearance.
e) The syringe scale shall be graduated in increments corresponding to units of only one concentration of insulin. The syringe scale graduation and numbering increments shall be determined through risk analysis and confirmed through usability validation testing.
NOTE 1 Annex H offers guidance from prior versions of ISO 8537 for graduation and numbering increments on U-40 and U-100 syringes.
f) The nominal capacity of the syringe shall be designated in millilitres (ml).
g) The tolerances on the graduated capacity shall be in accordance with Table H.1.BS EN ISO 8537 pdf download.