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dnaSRPS EN ISO 11607-3:2024

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

General information

50.20     Jun 4, 2026

50.60    Jul 28, 2026

ISS

Z076

European Norm

11.080.30  

English  

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

PROJECT
dnaSRPS EN ISO 11607-3:2024
50.20 Proof sent to secretariat or FDIS ballot initiated: 8 weeks
Jun 4, 2026

Related project

Adopted from FprEN ISO 11607-3 IDENTICAL

Adopted from ISO/FDIS 11607-3 IDENTICAL

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