ANSI/AAMI/ISO 11607-1:2006
Packaging for teminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging

Standard No.

ANSI/AAMI/ISO 11607-1:2006

Release Date

2005

Published By

American National Standards Institute （ANSI)

Status

Be replaced

Replace By

ANSI/AAMI/ISO 11607-1:2019

Latest

ANSI/AAMI/ISO 11607-1:2019

Scope

Specifies the requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use.

ANSI/AAMI/ISO 11607-1:2006 Referenced Document

• ISO 5636-5:2003 Paper and board - Determination of air permeance and air resistance (medium range) - Part 5: Gurley method

ANSI/AAMI/ISO 11607-1:2006 history

• 1970 ANSI/AAMI/ISO 11607-1:2019 Packaging for terminally sterilized medical devices— Part 1: Requirements for materials, sterile barrier systems and packaging systems
• 2005 ANSI/AAMI/ISO 11607-1:2006 Packaging for teminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging