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.

CEN - EN ISO 11607-1

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

active, Most Current
Organization: CEN
Publication Date: 1 January 2020
Status: active
Page Count: 58
ICS Code (Sterilized packaging): 11.080.30
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

EN ISO 11607-1
January 1, 2020
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
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...
July 1, 2017
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is...
June 1, 2009
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...
June 1, 2009
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...
April 1, 2006
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
A description is not available for this item.

References

Advertisement