ISO/DIS 15747

This Draft International Standard is in the enquiry phase with ISO members.

Will replace ISO 15747:2018

ISO/DIS 15747

CHF 65

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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.

General information

Status
: Under development

You can help develop this draft international standard by contacting your national member

Stage
: DIS ballot initiated: 12 weeks [40.20]
Edition
: 4

Number of pages
: 20
Technical Committee :
ISO/TC 76

ICS :
11.040.20
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