International Standard
ISO 8537:2016
Sterile single-use syringes, with or without needle, for insulin
Reference number
ISO 8537:2016
Edición 3
2016-03
International Standard
Vista previa
ISO 8537:2016
60510
No disponible en español
Publicado (Edición 3, 2016)
Esta norma se revisó y confirmó por última vez en 2021. Por lo tanto, esta versión es la actual.

ISO 8537:2016

ISO 8537:2016
60510
Idioma
Formato
CHF 151
Convertir Franco suizo (CHF) a tu moneda

Resumen

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).

Informaciones generales

  •  : Publicado
     : 2016-03
    : Norma Internacional confirmada [90.93]
  •  : 3
     : 27
  • ISO/TC 84
    11.040.25 
  • RSS actualizaciones

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