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EFHSS Questions and Answers - Question Q00227

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EFHSS - Questions & Answers - Packaging - Q00227
Is it correct to label medical devices on the dust cover of packs?
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From: (Italy)   Date: 12 December 2002, 15:52 [GMT]
Subject: Is it correct to label medical devices on the dust cover of packs?

Is correct to label medical devices on the dust cover of packs and not directly on the medical grade paper then put it into dust cover?

Alberto Franceschini

From: Josy Holdener (Switzerland)   Date: 13 December 2002, 08:35 [GMT]
Subject: Re: Is it correct to label medical devices on the dust cover of packs?

Hallo Alberto

Dust Covers are for use as "sterility maintenance" bags after packs have been sterilized, properly cooled and/or aerated. The over wrap must be clearly marked as a "dust cover" to prevent its use as a part of the sterile field. The dust cover must have a clear design to provide 100% visibility of the packs. Because all batch information have to be marked on the sterile pack and not on the dust cover.

Kind regards
Josy Holdener

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