DIN EN ISO 11607-3:2025-09
Packaging for terminally sterilized medical devices - Part 3: Requirements for process development for forming, sealing and assembly (ISO/DIS 11607-3:2025); German and English version prEN ISO 11607-3:2025 / Note: Date of issue 2025-08-08
| Fecha edición: |
2025-09-01
En Vigor
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| Idiomas disponibles: | Alemán, Inglés |
| Resumen: | 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. |
| Keywords: | Assembly|Definitions|Design|Developments|Forming|Heat-sealing|Hygiene|Medical devices|Medical sciences|Packages|Process|Process control|Process monitoring|Process specification|Public health|Risk management|Seals|Shape|Shaping|Specification (approval)|Sterile|Sterile barrier systems|Sterility|Sterilization (hygiene)|Sterilized|Sterilized goods |
| ICS: | 11.080.30 - Envases estériles |
| CTN: |
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