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I am new to medical device packaging. Why do so many products have porous windows in their packaging even though they are not gas-sterilised?

There are legacy PVC medical device products on the EU market that have been used in large volume over at least the past three decades with, presumably, no deleterious effects. They would be expected to fail the current 10993 testing (as PVC is used as a

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Published: May 14, 2010

Find more content on: Materials

Colour and Performance-Enhancing Materials Are Tested to ISO 10993

New colour and performance-enhancing materials for the medical market have been introduced by Clariant. The elastomer derivative polyether block amide, polyamide 11 and a dozen tailored products for catheter tubing feature, among other properties, radiopacity that enables visualisation even with thin-walled sections. Concentrates in standard or custom colours are biologically evaluated against USP Class VI part 87 and part 88 or the ISO 10993 standard.
Clariant International Ltd
Muttenz, Switzerland +41 61 469 5111
www.clariant.com

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