ISO 15747:2026

Plastic containers for intravenous injections

Datum objavljivanja: 12. 5. 2026.

Опште информације

Trenutna faza: 60.60 Effective date: 12. 5. 2026.

Inicijator: ISO

Pripada: ISO/TC 76

Vrsta: Međunarodni standard

ICS: 11.040.20

Jezik: engleski francuski

Kupovina

Status: Objavljen

PDF

Papir

PDF i papir

Jezik

Jezik na kome želite da primite dokument.

Apstrakt

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 1        In some countries, national or regional pharmacopoeias or other government regulations are legally binding, and these requirements take precedence over this document.
NOTE 2        Annex E provides explanations about the history of the development of the standard and summarises the different arguments discussed within ISO/TC 76 during the elaboration of the document.
NOTE 3        Annex F provides recommendations regarding sustainability.
NOTE 4        Annex G provides information on attributive and variable testing.

Životni ciklus

PRETHODNO

POVUČEN
ISO 15747:2018

TRENUTNO

OBJAVLJEN
ISO 15747:2026
60.60 Standard objavljen
12. 5. 2026.

Nacionalna preuzimanja

dnaSRPS EN ISO 15747:2024

ISS

Plastični kontejneri za intravenske injekcije

50.60 Završetak postupka odobravanja definitivnog teksta nacrta standarda

Z076 Saznaj više