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Compliance Guidelines for ISO11607-1 2010
2022-05-05
Industry Dynamics

The ISO 11607 standard was published by the International Organization for Standardization to guide medical device manufacturers and sterile packaging manufacturers on how to select and use appropriate packaging for terminally sterilized medical devices. The ISO 11607 standard consists of two parts: ISO 11607-1:2006(R)2010 Packaging for terminally sterilized medical devices, Part 1: Materials, sterile barrier systems and packaging systems and ISO 11607-2:2006(R) 2010 Packaging of Terminally Sterilized Medical Devices; Part 2: Validation Requirements for Forming, Sealing, and Assembly Processes.

DuPont™ Tyvek® Tyvek® medical packaging products are fully compliant with the ISO 11607-1:2006(R)2010 standard on the material section. The DuPont Medical Packaging Technology team wrote a compliance document for Tyvek® materials to ISO 11607-1:2006, which contains some of the necessary experimental data.

Biocompatibility

Tyvek® medical packaging products meet all acceptable performance criteria for biocompatibility - even after sterilization - after testing according to ISO 10993 and the United States Pharmacopeia (USP).

Food Contact and Pharmacopoeia Regulations

Tyvek® medical packaging products meet the optional or compositional requirements of various food contact and pharmacopeia regulations, such as Title 21 of the Code of Federal Regulations (21 CFR 177.1520), Commission Regulation (EU) Nº 10/2011 and Article 3.1 of the European Pharmacopoeia .5.

quality system
DuPont manufactures Tyvek® medical packaging products at its facilities in Richmond, Virginia, and Luxembourg, USA, which are ISO 9001:2008 certified. All facilities have a quality system manual (accreditation requirements) and strictly adhere to good manufacturing practices, laboratory practices and quality control requirements.

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