DPS
Drejtoria e Përgjithshme e Standardizimit
Tel/Cel: +355 4 222 62 55
E-mail: info@dps.gov.al
Adresa: Rr.: "Reshit Collaku", (pranë ILDKPKI, kati VI), Kutia Postare 98, Tiranë - Shqipëri
Main menu

ISO/DIS 11607-3

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

General information

40.00     27 qer 2025

ISO

ISO/TC 198

International Standard

11.080.30  

Scope

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.

Life cycle

NOW

IN_DEVELOPMENT
ISO/DIS 11607-3
40.00 DIS registered
27 qer 2025