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Sterile U

FAQ's, Frequently Asked Questions.

In our organisation we receive often questions of our costumers in the field of sterilization. If a question is asked frequently, we will share the question on this webisit. If youhave a question, please drop it at your local representative or contact us

If you have summitted a question our specialist in sterilization in your region or in our organisation will try to find an answer for you.

Frequently Asked Questions

Can the helix replace the Bowie and Dick package for large sterilizers?

Generally speaking: No, it cannot. In the Educational Resources area you find the presentation with the details out of the norms which makes this clear. In addition, the user of endoscopes could ask themselves if the helix is representing the medical devices they are sterilizing.

A Bowie & Dick test is a steam penetration test. It is not necessarily a projection of your load. If the test should be a representative of the load to be sterilized, the helix is not a good representative, the user should ask the following questions:

  • Are the dimensions of the helix representing the instruments?
  • Is the tubing of the helix, representing the lumen in the instruments, I want to sterilize, e.g., the heat capacity, the heat transfer, the density. (Often instruments are complex or have several layers of material which is not represented by a single material of the helix tube.)

At this moment many literature is available about the Bowie and Dick test. Scientific papers (publications in peer reviewed journals that have a impact factor) on penetration of lumen is limited. Research is on going.

Summarized: A good steam penetration test has to fulfil the ISO 11140-3 or the ISO 11140-4. If a product is claimed to fulfil the norms, it is advisable to ask for the prove and the under laying data, necessary for the claim.

Are norms obligated or mandatory for hospitals?

No, if you have another way to prove your claim and you can prove equivalence with the norms or show to be better, it is also allowed. Please note that norms describe the minimum requirements, so if you have a better way it is allowed.

Many hospitals and people use the norms, because it should make things easy to compare, which can simplify situations.