ISO/CD 15747

Plastic containers for intravenous injections

General information

30.99 CD approved for registration as DIS   Mar 25, 2024

ISO

ISO/TC 76 Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use

International Standard

11.040.20   Transfusion, infusion and injection equipment

Scope

This document specifies requirements to the safe handling and the physical, chemical and biological testing of plastic containers for parenterals.
This document is applicable to plastic containers for parenterals having one or more chambers and having a total nominal capacity in the range of 50 ml to 5 000 ml such as film bags or blow-moulded plastic bottles for direct administration of infusion (injection) solutions.
NOTE In some countries, national or regional pharmacopoeias or other government regulations are legally binding and these requirements take precedence over this document.

Life cycle

PREVIOUSLY

PUBLISHED
ISO 15747:2018

NOW

IN_DEVELOPMENT
ISO/CD 15747
30.99 CD approved for registration as DIS
Mar 25, 2024