Reference number
ISO 11040-8:2016
International Standard
ISO 11040-8:2016
Prefilled syringes — Part 8: Requirements and test methods for finished prefilled syringes
Edition 1
2016-11
Preview
ISO 11040-8:2016
66036
No disponible en español
Publicado (Edición 1, 2016)

ISO 11040-8:2016

ISO 11040-8:2016
66036
Idioma
Formato
CHF 63
Convertir Franco suizo (CHF) a tu moneda

Resumen

ISO 11040-8:2016 is applicable to aseptically filled or terminally sterilized finished prefilled syringes (intended for single use only) based on ISO 11040‑4 or ISO 11040‑6, together with ISO 11040‑5, for parenteral injection preparations with focus on quality, functional performance and safety requirements, as well as relevant test methods.

Finished prefilled syringes which have undergone an additional preparation step by the user before injection (e.g. diluent syringes that have been emptied for reconstitution and in which the reconstituted drug solution has been aspirated after reconstitution) are excluded from the scope of ISO 11040-8:2016.

Informaciones generales

  •  : Publicado
     : 2016-11
    : Norma Internacional para revisar [90.92]
  •  : 1
     : 9
  • ISO/TC 76
    11.040.25 
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