Module 14 2022

24/03/2022

ISO STANDARDS…

ISO 11607-1: 2019 ● Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systems ISO 11607-2: 2020 ● Packaging for terminally sterilized medical devices -- Part 2: Validation requirements for forming, sealing and assembly processes

Interactive Session

The Organisation for Professionals in Regulatory Affairs

15

FOUR KEY AREAS 1. ISO 11607

Stability testing (accelerated ageing and real-time ageing)

2.

Performance / Dynamics Testing

3.

Packaging Strength Testing

4.

Package Integrity Testing

PLUS… ● Requirements on physical properties, material performance, sample size, labelling, documentation

Interactive Session

The Organisation for Professionals in Regulatory Affairs

16

8