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Sterility symbol compromise

This article was originally published in Clinica

Executive Summary

The European standards committee, CEN, has approved a new symbol for indicating sterility of medical devices. This is effectively a compromise symbol aimed at manufacturers of products that cannot tolerate sterilisation to 10-(6), the level required to apply the symbol for absolute sterility. The new symbol, which will be introduced in a second amendment to the European standard on medical device labelling and symbols, EN 980, is for aseptic processing.

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