Guidance for packaging of sterilized medical devices published
In June 2014 Technical Specification NPR-CEN-ISO/TS 16775 was published for packaging for terminally sterilized medical devices. This TS provides guidance for the application of the requirements contained in ISO 11607-1 and ISO 11607-2. ISO 11607-1 specifies the requirements for materials, sterile barrier systems, and packaging systems, including the qualification of the packaging system design and evaluation of that design. ISO 11607-2 specifies the requirements for packaging process validation. In Europe ISO 11607-1 is designed and used as a tool for demonstrating compliance with the relevant essential requirements of the Medical Device Directive (World Packaging Standardisation Newsletter, July 2014).
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