Skip to main content
Back

ISO 11607-1:2006

Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systems

General information

Withdrawn from 31.01.2019
Directives or regulations
None

Standard history

Status
Date
Type
Name
31.01.2019
Main
07.07.2014
Amendment
07.04.2006
Main
Main
ISO 11607:2003
ISO 11607-1:2006 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 until the point of use.
ISO 11607-1:2006 is applicable to industry, to health care facilities, and wherever medical devices are placed in sterile barrier systems and sterilized.
ISO 11607-1:2006 does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements might also be necessary for drug/device combinations.
ISO 11607-1:2006 does not describe a quality assurance system for control of all stages of manufacture.

Required fields are indicated with *

*
*
*
PDF
82.61 € incl tax
Paper
82.61 € incl tax
Standard monitoring