ISO 11607-2:2019
Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
This document specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.
It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilized.
It does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
4.1 Quality systems
4.2 Risk management
4.3 Sampling
4.4 Test methods
4.5 Documentation
5 Validation of packaging processes
5.1 General
5.2 Installation qualification
5.3 Operational qualification
5.4 Performance qualification
5.5 Formal approval of the process validation
5.6 Process control and monitoring
5.7 Process changes and revalidation
6 Assembly
7 Use of reusable sterile barrier systems
8 Sterile fluid-path packaging
Annex A (informative) Process development
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
4.1 Quality systems
4.2 Risk management
4.3 Sampling
4.4 Test methods
4.5 Documentation
5 Validation of packaging processes
5.1 General
5.2 Installation qualification
5.3 Operational qualification
5.4 Performance qualification
5.5 Formal approval of the process validation
5.6 Process control and monitoring
5.7 Process changes and revalidation
6 Assembly
7 Use of reusable sterile barrier systems
8 Sterile fluid-path packaging
Annex A (informative) Process development
Bibliography