ISO 11040-8:2016

Status : Published (To be revised)

This standard will be replaced by ISO/AWI 11040-8

	Format	Language
std 1 61	PDF
std 2 61	Paper

CHF61

Convert Swiss francs (CHF) to your currency

Abstract

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.

General information

Status
: Published

Publication date
: 2016-11

Stage
: International Standard to be revised [90.92]
Edition
: 1

Number of pages
: 9
Technical Committee :
ISO/TC 76

ICS :
11.040.25
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