En cours de publication
ISO 11607-3
Emballages des dispositifs médicaux stérilisés au stade terminal — Partie 3: Exigences relatives à la mise au point des procédés de formage, scellage et assemblage
Numéro de référence
ISO 11607-3
ISO 11607-3
Edition 1
2026-09
2026-09
© ISO 2026
En cours de publication
ISO 11607-3
87167
En cours de publication
(Edition 1, 2026)
Étapes finales du processus d’élaboration (jusqu’à sept semaines).
Résumé
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.
Informations générales
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État actuel: ProjetDate de publication: 2026-09Stade: Norme internationale en cours de publication [60.00]
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Edition: 1
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Comité technique :ISO/TC 198ICS :11.080.30
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