ANSI/AAMI/ISO 11607-2:2006
Packaging for terminally sterilized medical devices - Part 2: Validation and requirements for forming, sealing and assembly processes

Standard No.

ANSI/AAMI/ISO 11607-2:2006

Release Date

2005

Published By

American National Standards Institute （ANSI)

Status

Be replaced

Replace By

ANSI/AAMI/ISO 11607-2:2019

Latest

ANSI/AAMI/ISO 11607-2:2019

Scope

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.

ANSI/AAMI/ISO 11607-2:2006 Referenced Document

• ISO 11607-1 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems — Amendment 1*， 2009-12-01 Update

ANSI/AAMI/ISO 11607-2:2006 history

• 1970 ANSI/AAMI/ISO 11607-2:2019 Packaging for terminally sterilized medical devices— Part 2: Validation requirements for forming, sealing and assembly processes
• 2005 ANSI/AAMI/ISO 11607-2:2006 Packaging for terminally sterilized medical devices - Part 2: Validation and requirements for forming, sealing and assembly processes