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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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Watch the archived free webcast "How to Achieve Compliance with IEC 62304 for Medical Device Software Development." Complying with the IEC 62304 standard for medical device software requires an established software lifecycle process that includes strong support for risk management and safety assessment. However, IEC 62304 compliance does not need to slow down your medical device software development.

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Published: May 24, 2010

Find more content on: Packaging and Sterilisation

Rotary Heat-Sealing Machines Comply with Medical Directives

Founded in 1946, Famos bv specialises in the production of rotary heat-sealing machines. The company’s line of heat sealers consists of 13 models, ranging from basic sealing machines to sophisticated heat sealers that can print data. The heat sealers comply with the medical directives and carry CE and TÜV certification. The machines are distributed internationally by more than 60 distributors. The manufacturer also produces a variety of sterilisation equipment.
Famos bv
Venlo, Netherlands +31 77 3548800
www.famos.nl

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