Standard

SN EN ISO 15747:2019

Nov 2019 Current

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Abstract

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.

Products specifications

Standard from INB
Published: November 1 2019
Effective: November 1 2019
Document type: EN
Pages
ISBN:

ICS: 11.040.20
Publisher: SNV
Distributor: SNV
National Committee: INB/NK 2205
European TC: CEN/SS S03
International TC: ISO/TC 76

Swiss Federal Authority: SWISSMEDIC
Designated under following Swiss law: 812.213
Designated under following EU law: Directive 2007/47/EC, Council Directive 93/42/EEC

Product Relations

Adopted from: ISO 15747:2018, IDT
Replaces: SN EN ISO 15747:2012

SN EN ISO 15747:2019

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