GOST R 59747.8-2021 - Std. & Spec

Scope: This standard contains quality, performance and safety requirements, as well as associated test methods, for finished prefilled syringes (intended for single use only), aseptically filled or terminally sterilized, which have been manufactured in accordance with GOST R 59747.4 or GOST R 59747.6. as well as GOST R 59747.5, and containing dosage forms for parenteral use. This standard does not apply to pre-filled syringes that require additional action by the user prior to injection [e.g., diluent syringes whose contents are used to prepare a solution and then the reconstituted drug solution is drawn into the syringe after reconstitution]

GOST R 59747.8-2021 history

2021 GOST R 59747.8-2021 Prefilled syringes. Part 8. Requirements and test methods for finished prefilled syringes