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About This Item

 

Full Description

AAMI/ISO 11607-1 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.

Amendment 1:2014 is included in this document.
 

Document History

  1. AAMI/ISO 11607-1: 2019


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

    • Most Recent
  2. AAMI/ISO 11607-1:2006/(R)2015

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

    • Historical Version
  3. AAMI/ISO 11607:2000


    Packaging for terminally sterilized medical devices

    • Historical Version
  4. AAMI 11607:1997


    Packaging for terminally sterilized medical devices

    • Historical Version
 

Amendments, rulings, supplements, and errata

  1. AAMI/ISO 11607-1:2006/A1:2014


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