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SRPS EN ISO 15747:2019

Plastic containers for intravenous injections (ISO 15747:2018)

Jul 31, 2019

General information

60.60     Jul 31, 2019

ISS

Z076

European Norm

11.040.20  

English  

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Published

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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.

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.

93/42/EEC

Medical devices

Harmonized
Directive 93/42/EEC
2007/47/EC

Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market

Directive 2007/47/EC

Life cycle

PREVIOUSLY

WITHDRAWN
SRPS EN ISO 15747:2012

NOW

PUBLISHED
SRPS EN ISO 15747:2019
60.60 Standard published
Jul 31, 2019

REVISED BY

PROJECT
naSRPS EN ISO 15747:2024

Related project

Adopted from EN ISO 15747:2019

Adopted from ISO 15747:2018