DIN EN ISO 11607-1:2009
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006); English version of DIN EN ISO 11607-1:2009-09

Standard No.

DIN EN ISO 11607-1:2009

Release Date

2009

Published By

German Institute for Standardization

Status

Withdraw

Replace By

DIN EN ISO 11607-1:2014

DIN EN ISO 11607-1/A1 E:2013

Latest

DIN EN ISO 11607-1:2024-02

Replace

DIN EN ISO 11607-1:2006 DIN EN ISO 11607-1 Berichtigung 1:2007 DIN EN ISO 11607-1/A1:2009

Scope

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 sterility of terminally sterilized medical devices until the point of use. This part of ISO 11607 is applicable to industry, to health care facilities, and wherever medical devices are placed in sterile barrier systems and sterilized. This part of ISO 11607 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. This part of ISO 11607 does net describe a quality assurance system for control of all stages of manufacture.

DIN EN ISO 11607-1:2009 Referenced Document

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

DIN EN ISO 11607-1:2009 history

• 2024 DIN EN ISO 11607-1:2024-02 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019 + Amd 1:2023); German version EN ISO 11607-1:2020 + A1:2023
• 2022 DIN EN ISO 11607-1/A1:2022-08 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems - Amendment 1 (ISO 11607-1:2019/DAM 1:2022); German and English version EN ISO 11607-1:2020/prA1:2022 / Note: Date o...
• 2022 DIN EN ISO 11607-1 A11:2022 Packaging for medical devices to be sterilized in the final packaging – Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
• 2020 DIN EN ISO 11607-1:2020-05 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019); German version EN ISO 11607-1:2020 / Note: To be amended by DIN EN ISO 11607-1/A1 (2022-08).
• 2020 DIN EN ISO 11607-1:2020 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
• 1970 DIN EN ISO 11607-1 E:2017-11 Packaging of medical devices to be sterilized in final packaging Part 1: Requirements for materials, sterile barrier systems and packaging systems (draft)
• 2017 DIN EN ISO 11607-1:2017 Packaging for medical devices to be sterilized in the final packaging – Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006 + Amd 1.:2014); German version EN ISO 11607-1:2017
• 2016 DIN EN ISO 11607-1 Berichtigung 1:2016 Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems
• 2014 DIN EN ISO 11607-1:2014 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006 + Amd 1:2014); German version EN ISO 11607-1:2009 + A1:2014
• 2009 DIN EN ISO 11607-1:2009 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006); English version of DIN EN ISO 11607-1:2009-09
• 2007 DIN EN ISO 11607-1 Berichtigung 1:2007 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006); German version EN ISO 11607-1:2006, Corrigenda to DIN EN ISO 11607-1:2006-07
• 0000 DIN EN ISO 11607-1:2006