Standard

NS-EN ISO 15747:2019

Jun 2019 Published

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Language English

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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.

Document information

Standard from SN
Published: 1 June 2019
Edition: 2019-03
Version: 1
Document type: NAT
ISBN:

ICS 11.040.20
National Committee CEN/TC 205

Legal references

EU law: 93/42/EEC, 2007/47/EC

Product Relations

Replaces: NS-EN ISO 15747:2011
Adopted from: EN ISO 15747:2019 , 0

Product life cycle

Previous product

Withdrawn

NS-EN ISO 15747:2011
Current product

Published

NS-EN ISO 15747:2019

NS-EN ISO 15747:2019

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