DuPont™Tyvek® Spunbonded Olefin is intended for packaging of terminally sterilized medical
devices. To guide the medical device manufacturers and sterile packaging producers in their
selection and use of packaging, the International Standards community has promulgated the
ISO 116071:2006 Packaging for terminally sterilized medical devices Part 1: Materials, sterile
barrier systems and packaging systems and ISO 116072:2006 Packaging for terminally sterilized
medical devices Part 2: Validation Requirements for forming, sealing and assembly requirements.
As the producer of Tyvek® for medical packaging, DuPont Medical Packaging has compiled
documentation which demonstrates the compliance of Tyvek® with the materials portion of the
ISO 116071:2006 standard. This will allow medical device manufacturers and sterile packaging
manufacturersto focus on the package material production, final package design qualification, and
the device package process validation portions of the standard. The compliance is supported by a
number of DuPont Technical Information Documents (TIDs) which contain the necessary experimental
data. In this preamble, the documentsare described and their applicability to the various sections of
the ISO 116071:2006 document explained. The TIDs which cover testing on sterile barrier systems
can be used to demonstrate packaging compliance to this standard.
