0 Stavka
Moj nalog
Telefon: (011) 7541-421, 3409-301, 3409-335, 6547-293, 3409-310
E-mail: Prodaja standarda: prodaja@iss.rs Seminari, obuke: iss-edukacija@iss.rs Informacije o standardima: infocentar@iss.rs
Stevana Brakusa 2, 11030 Beograd
Glavni meni

ISO 11040-7:2024

Prefilled syringes — Part 7: Packaging systems for sterilized subassembled syringes ready for filling
3. 6. 2024.

Опште информације

60.60     3. 6. 2024.

ISO

ISO/TC 76

Međunarodni standard

11.040.25  

engleski   francuski  

Kupovina

Objavljen

Jezik na kome želite da primite dokument.

Apstrakt

This document specifies a packaging system that is used to deliver sterilized subassembled syringes ready for filling in tubs and nests.
Downstream processes (processes after filling such as in house/outside transport, reprocessing) can result in specific requirements on the packaging system used to deliver sterilized subassembled syringes ready for filling. However, these requirements are not within the scope of this document.
NOTE 1        Glass barrels and sterilized subassembled syringes ready for filling, plunger stoppers, and plastic barrels for injectables are specified in ISO 11040-4, ISO 11040-5 and ISO 11040-6.
NOTE 2        ISO 11607-2 addresses validation requirements of sealing and packaging processes for medical devices.

Životni ciklus

PRETHODNO

POVUČEN
ISO 11040-7:2015

TRENUTNO

OBJAVLJEN
ISO 11040-7:2024
60.60 Standard objavljen
3. 6. 2024.