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Sterile U

Standards Update

Norm and standards are constantly changing in time. This can be because of new insight, new development or needs of the users of norms and standards. On this page periodically the changes will be addressed.

Sterilization Standard Updates (PDF, 2.15 MB)

Biological Indicators (ISO 11138) - Hydrogen peroxide sterilization

The work group for the ISO standard for biological indicators (ISO 11138) would like to prepare a norm for Biological indicators for hydrogen peroxide sterilization. Insufficient scientific data or evidence based information is available to start making a norm. Manufacturers of hydrogen peroxide sterilizers are or will be asked for input. As soon as this information is available the work group will start writing the norm.

Incubation time

In the last norm committee meeting (Berlin, June 2009) a proposal for Reduced Incubation Time is presented to the norm committee. The norm committee decided that time is needed to study the proposal and discuss the proposal next meeting (most probably, January 2010). The first remark made on the proposal is that more experimental data is needed to be able to form an opinion on the proposal.

Chemical Indicators (ISO 11140)

A concept document for the ISO 11140 part 6 is in discussion. The ISO 11140 part 6 should replace and supersedes the European Norm EN 867 part 5 (Non-biological systems for use in sterilizers - Part 5: Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S). It is decided that a round robin test is needed before progressing the draft document for the ISO 11140 part 6. Four companies will perform the tests. The results will be discussed. If the work group is satisfied with the results, a proposal for the ISO 11140 part 6 will be prepared.

In the mean time the EN 867 part 5 stays enforced.