UNE-EN ISO 15747:2026
Current
The latest, up-to-date edition.
Plastic containers for intravenous injections (ISO 15747:2026) (Endorsed by Asociación Española de Normalización in July of 2026.)
Hardcopy , PDF
English
01-07-2026
This document specifies requirements to the safe handling and the physical, chemical and biological testingof plastic containers for parenterals.This document is applicable to plastic containers for parenterals having one or more chambers and having atotal nominal capacity in the range of 50 ml to 5 000 ml such as film bags or blow-moulded plastic bottlesfor direct administration of infusion (injection) solutions.NOTE In some countries, national or regional pharmacopoeias or other government regulations are legallybinding, and these requirements take precedence over this document.NOTE Upon implementing this document, readers are encouraged to consider measures to actively reduce the useof natural resources and minimize the ecological footprint to increase sustainability. In that respect, Annex F providesrecommendations of points to consider, from materials of construction and design, to testing strategy and sampling size.
| Committee |
CTN 111
|
| DocumentType |
Standard
|
| Pages |
25
|
| PublisherName |
Asociación Española de Normalización
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| I.S. EN ISO 15747:2026 | Equivalent |
| EN ISO 15747:2026 | Identical |
| ISO 15747:2026 | Identical |
| BS EN ISO 15747:2026 | Equivalent |