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ISO 11607-3:2026

Packaging for terminally sterilized medical devices — Part 3: Requirements for process development for forming, sealing and assembly
18. 9. 2026.

Опште информације

60.60     18. 9. 2026.

ISO

ISO/TC 198

Međunarodni standard

11.080.30  

engleski   francuski  

Kupovina

Objavljen

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Apstrakt

This document specifies requirements for process development for forming, sealing and assembly of packaging for medical devices to be terminally sterilized, when utilizing heat sealing technologies.
This document recommends minimum heat sealing equipment features to support subsequent validation, process control and monitoring.
This document applies to both preformed sterile barrier systems and sterile barrier systems.
This document utilizes the sterile barrier system specification to develop the process specification using the principles of risk management.
This document is intended to be used prior to process validation.
NOTE            ISO 11607-2 provides requirements for process specification and process validation.

Životni ciklus

TRENUTNO

OBJAVLJEN
ISO 11607-3:2026
60.60 Standard objavljen
18. 9. 2026.

Nacionalna preuzimanja

dnaSRPS EN ISO 11607-3:2024  
ISS

Pakovanje za terminalno sterilisana medicinska sredstva - Deo 3: Zahtevi za razvoj procesa oblikovanja, zaptivanja i sklapanja

50.60   Završetak postupka odobravanja definitivnog teksta nacrta standarda

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