Survey on symbols for Sterile Barrier Systems - ongoing - 22 January 2018

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The new European Medical Devices Regulation (MDR) introduces a few specific
changes in the ‘General Safety and Performance Requirements’ (SPRs) which
have to be considered for the revision of harmonized standards related to
Sterile Barrier Systems. The SBA published a Position Paper on transition
challenges ‘Moving from the MDD to the MDR - A summary of Key Changes
regarding Sterile Packaging and considerations on recommended changes to
standards’, read full text
There will be also new sterile packaging labelling and extended documentation
requirements. To collect stakeholder feedback on various proposals for an
applicable symbol that identifies the sterile barrier system, the SBA is
conducting a survey on the usability of various proposals. The idea of this
symbols is to assist end-users when using sterile barrier systems and to
perform proper aseptic technique when transferring devices from their sterile
barrier systems in an aseptic manner.
The SBA invites you to participate in this online survey: EnglishFrench
German - Dutch
If you prefer to use a PDF download and return the scanned survey form by
email, please follow the links to EnglishFrenchGermanDutch PDF
versions.

Many thanks in advance for your participation.