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MEST EN ISO 15747:2020

Plastic containers for intravenous injections (ISO 15747:2018)

Dec 1, 2020

Published

Standard

European Norm

1

ISME

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Related project

Adopted from EN ISO 15747:2019

Adopted from ISO 15747:2018

Replaces MEST EN ISO 15747:2015

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.

Project

MEST EN ISO 15747:2020

60.60 Standard published

ICS

11.040.20 11.040.20 11.040.20