BAS EN ISO 15747:2020
Plastic containers for intravenous injections
General Information
Status: Published
No. of pages: 22
Language: English
Edition: 3.
Adoption method: Endorsment
Publication date: 30.09.2020
Technical committee:
Directive:
93/42/EEC, Medical devices
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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.
Lifecycle
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Original document and degree of correspondence
- EN ISO 15747:2019, identical
- ISO 15747:2018, identical