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prEN ISO 11607-3

Packaging for terminally sterilized medical devices - Part 3: Requirements for process development for forming, sealing and assembly (ISO/DIS 11607-3:2025)

Draft Public enquiry
Comment end date 2025-11-11
Export comments Read draft and comment

Project stage codes

1. Prioritetinių darbo temų pažymėjimas ir ekspertų skyrimas
2. Projektas
3. Viešoji apklausa
From 2025-09-12 till 2025-11-11
4. Closure of enquiry
5. Submission to Formal Vote

Organisation

CEN Europos standartizacijos komitetas

Technical Committee

TK 32 Health

ForeignTC'S

CEN/TC 102

Number of comments

0

Comment start date

2025-09-12

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.