Tyvek® Complies with ISO 11607-1:2006/Amd.1:2014 Standard
The ISO 11607 Standard was promulgated by the International Standards community to guide medical device manufacturers and sterile packaging manufacturers in their selection and use of packaging for terminally sterilized medical devices. The ISO 11607 Standard is comprised of two parts: ISO 11607-1:2006/Amd.1:2014 Packaging for terminally sterilized medical devices Part 1: Materials, sterile barrier systems and packaging systems and ISO 11607-2:2006/Amd.1:2014 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes.
As the producer of Tyvek® for medical and pharmaceutical packaging, DuPont Medical and Pharmaceutical Protection has compiled documentation that demonstrates the compliance of Tyvek® to the materials portion of the ISO 11607-1:2006/Amd.1:2014 Standard. This will allow medical device manufacturers and sterile packaging manufacturers to focus on the package material production, final package design qualification and the device package process validation portions of the standard.
Compliance of Tyvek® to the ISO 11607-1:2006/Amd.1:2014 Standard is supported by DuPont technical information which contains the necessary experimental data. The DuPont™ Tyvek® Compliance to ISO 11607-1:2006/Amd.1:2014 guidebook can be downloaded here. This guidebook lists each clause from sections 4 and 5 of the ISO 11607-1:2006/Amd.1:2014 Standard that contains a requirement, followed by compliance information for the requirement.
Much of the information used to demonstrate packaging compliance to the ISO 11607-1:2006/Amd.1:2014 Standard, is presented in the DuPont Technical Reference Guide for Medical and Pharmaceutical Packaging.