UNLIMITED FREE ACCESS TO THE WORLD'S BEST IDEAS

close
Already an Engineering360 user? Log in.

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

Customize Your Engineering360 Experience

close
Privacy Policy

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

AAMI 11607-1

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

active, Most Current
Buy Now
Organization: AAMI
Publication Date: 1 January 2019
Status: active
Page Count: 57
scope:

This document specifies 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.

It is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile barrier systems and sterilized.

It does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.

It does not describe a quality assurance system for control of all stages of manufacture.

It does not apply to packaging materials and/or systems used to contain a contaminated medical device during transportation of the item to the site of reprocessing or disposal.

Document History

AAMI 11607-1
January 1, 2019
Packaging for terminally sterilized medical devices— Part 1: Requirements for materials, sterile barrier systems, and packaging
This document specifies requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of...
January 1, 2006
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging
This part of ISO 11607 specifies the requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain...
January 1, 2006
Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems, and packaging
This part of ISO 11607 specifies the requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain...
January 1, 2006
Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems, and packaging systems
This part of ISO 11607 specifies the requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain...

References

Advertisement