eLibrary >
ANSI/AAMI/ISO 11607-2:2019 - Packaging for terminally sterilized medical devices-Part 2: Validation requirements for forming, sealing and assembly processes >
Expand All
TOC Search:
ANSI/AAMI/ISO 11607-2:2019 - Packaging for terminally sterilized medical devices-Part 2: Validation requirements for forming, sealing and assembly processes, 2019
- ANSI/AAMI/ISO 11607-2:2019; Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and assembly processes
- Objectives and uses of AAMI standards and recommended practices
- Title page
- AAMI Standard
- Copyright information
- Contents
- Committee representation
- Background of ANSI/AAMI adoption of ISO 11607-2:2019
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 General requirements [Go to Page]
- 5 Validation of packaging processes [Go to Page]
- 6 Assembly
- 7 Use of reusable sterile barrier systems
- 8 Sterile fluid-path packaging
- Annex A (informative) Process development
- Bibliography [Go to Page]
