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Ethylene oxide in medical devices

Reliable quality control of medical devices is a precondition for production in accordance with international standards and for successful product marketing. EN ISO 10993-7 regulates the quality control of these medical devices.

A new version of the EN ISO 10993-7 standard has been in force since October 2008 and contains important changes to allowable limits.

Manufacturers of medical devices are obliged to perform analytical tests on residue from sterilisation procedures in accordance with international standards. The task of analytics is to establish whether the prescribed limits are being adhered to.

The essential changes refer to allowable limits for ethylene oxide and ethylene chlorohydrin. New specifications have been issued for various special products. The revised standard also provides information on tolerable doses for products that come into contact with body surface areas. A wide range of special cases are also explicitly regulated.

The following table provides an overview of changes to allowable limits:

UFAG LABORATORIEN has optimised the analytical procedure to determine ethylene oxide residue in medical devices and, in addition to analytical services, also provides consultancy on this standard.