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EN ISO 11607-3:2026

Packaging for terminally sterilized medical devices - Part 3: Requirements for process development for forming, sealing and assembly (ISO 11607-3:2026)

Edition date: 2026-09-30
In Force
Available languages: French, English
Summary: 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.

Dieses Dokument legt Anforderungen an die Prozessentwicklung für die Formgebung, Siegelung und das Zusammenstellen von Verpackungen für in der Endpackung sterilisierte Medizinprodukte fest, wenn dabei Heißsiegelungstechniken verwendet werden. Dieses Dokument enthält Empfehlungen für die Mindestausstattung von Heißsiegelungsausrüstungen, um die anschließende Validierung, Prozesssteuerung und -überwachung zu unterstützen. Dieses Dokument ist sowohl für vorgefertigte Sterilbarrieresysteme als auch für Sterilbarrieresysteme anwendbar. In diesem Dokument dient die Spezifikation des Sterilbarrieresystems dazu, die Prozessspezifikation durch Anwendung der Grundsätze des Risikomanagements zu entwickeln. Dieses Dokument ist für die Anwendung vor der Prozessvalidierung vorgesehen. ANMERKUNG ISO 11607 2 enthält Anforderungen für die Prozessspezifikation und Prozessvalidierung.

Le présent document spécifie les exigences relatives à la mise au point des procédés de formage, scellage et assemblage des emballages des dispositifs médicaux devant être stérilisés au stade terminal, lorsque des technologies de thermoscellage sont utilisées. Le présent document recommande des caractéristiques minimales de l'équipement de thermoscellage pour assurer la validation, la maîtrise et la surveillance ultérieures du procédé. Le présent document s'applique aux systèmes de barrière stérile, comprenant systèmes de barrière stérile préformés. Le présent document utilise la spécification du système de barrière stérile pour élaborer la spécification du procédé tout en appliquant les principes de gestion des risques. Le présent document est destiné à être utilisé avant la validation du procédé. NOTE            L'ISO 11607-2 fournit des exigences relatives à la spécification du procédé et à la validation du procédé.
ICS: 11.080.30-Sterilized packaging
CTN: CEN/TC 102 - 6085

Otras Relaciones

Acuerdo de Viena ISO 11607-3:2026

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