AAMI 11607 2 2019
$75.64
ANSI/AAMI/ISO 11607-2:2019 – Packaging for terminally sterilized medical devices-Part 2: Validation requirements for forming, sealing and assembly processes
| Published By | Publication Date | Number of Pages |
| AAMI | 2019 | 26 |
Specifies the requirements for development and validation of processes for packaging medical devices that are terminally sterilized and maintain sterility to the point of use. These processes include forming, sealing, and assembly of preformed sterile barrier systems, sterile barrier systems, and packaging systems.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO 11607-2:2019; Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and assembly processes |
| 2 | Objectives and uses of AAMI standards and recommended practices |
| 3 | Title page |
| 4 | AAMI Standard Copyright information |
| 5 | Contents |
| 6 | Committee representation |
| 9 | Background of ANSI/AAMI adoption of ISO 11607-2:2019 |
| 10 | Foreword |
| 11 | Introduction |
| 13 | 1 Scope 2 Normative references 3 Terms and definitions |
| 18 | 4 General requirements 4.1 Quality systems 4.2 Risk management 4.3 Sampling 4.4 Test methods |
| 19 | 4.5 Documentation 5 Validation of packaging processes 5.1 General |
| 20 | 5.2 Installation qualification |
| 21 | 5.3 Operational qualification |
| 22 | 5.4 Performance qualification 5.5 Formal approval of the process validation 5.6 Process control and monitoring |
| 23 | 5.7 Process changes and revalidation 6 Assembly |
| 24 | 7 Use of reusable sterile barrier systems 8 Sterile fluid-path packaging |
| 25 | Annex A (informative) Process development |
| 26 | Bibliography |
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