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Click here to download the ISO11607-1:2006 Compliance Document in English, French, German or Chinese.
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 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Materials, sterile barrier systems and packaging systems and ISO 11607-2:2006 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 11607-1:2006 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. The compliance is supported by a number of DuPont Technical Information Documents (TIDs) which contain the necessary experimental data. In this preamble, the documents are described and their applicability to the various sections of the ISO 11607-1:2006 document explained. The TIDs which cover testing on sterile barrier systems can be used to demonstrate packaging compliance to this standard.
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