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FAQ

Is Safe Sterilization ApS ISO certified?

Yes, Safe Sterilization ApS was certified in 2016 according to DS/EN ISO 9001:2015. The certification has been completed by DNV-GL. SAFE Sterilization is recertified once a year.

How should the biological indicators be placed in the autoclave/dry sterilizer?

The biological indicators are placed where it is most difficult for the steam to penetrate in the goods, and where the heat has the greatest difficulty at penetrating the goods in the dry sterilizer.
The biological indicators are used in the sterilizer and can be placed in autoclave bags and cassettes (if used). The position of the biological indicators should be as close to everyday use as possible. Place the biological indicators in three different places in the autoclave/dry sterilizer, e.g. top, middle, and bottom.

Should I open the biological indicators?

No, the construction of the biological indicators protects against contamination by foreign microorganisms. The resistance of biological indicators (D-value) are measured in manner as the biological indicators is delivered to our customers.

I got a new autoclave/dry sterilizer, should I write the new name on the labels on the biological indicators?

Yes, when we receive the biological indicators from you, we update our database with the new equipment name/ID. You will subsequently receive a certificate with the correct equipment name on the certificate.

What is the process time for the most used sterilization methods?

Steam sterilization:      

  • 121°C for a minimum of 15 min.
  • 134°C for a minimum of 3 min.               

Dry heat sterilization:         

  • 160°C for a minimum of 2 hours.
  • 170°C for a minimum of 1 hour.
  • 180°C for a minimum of 30 min.

NB. It is important that the sterilization time is counted from the time the specified temperature is obtained in the sterilizer.

What is the reason for my sterilizers process is not approved?

  • Did you remember to run the test before you returned the biological indicators?
  • Has the autoclave/dry sterilizer achieved the specified sterilization temperature?
  • Is the specified sterilization time achieved? Remember, the process time is from the moment the autoclave/dry sterilizer has reached the specified sterilization temperature.
  • Were any errors or alarms triggered on the autoclave/dry sterilizer during the run with the biological indicators? If so, consult the manual and/or the supplier of the equipment.

Our autoclave/dry sterilizer is for repair, what should we do with the received biological indicators?

We recommend you run the biological indicators in a borrowed autoclave/dry sterilizer. This is in accordance with the Danish “Nationale infektionshygiejniske retningslinjer” NIR, which contains recommendations regarding procedures and handling of medical devices. Consult your national guidelines as to ensure you and your sterilization processes are in accordance with relevant regulation. Correct the machine name on the labels and remember to note “borrowed equipment”.

When your autoclave/dry sterilizer returns from repair, the equipment must be tested with biological indicators before use, as per the NIR guidelines. Please consult your national guidelines to ensure you comply with relevant regulations. Contact SAFE Sterilization for purchase of additional biological indicators.

Contact Safe Sterilization for purchase of additional biological indicators.

Our test showed growth. Do we get a new test?

Yes, if you join our subscription plan with tests every month, we send new biological indicators tests free of charge.

For other types of subscription (for example, every 3 months), you receive a (one) set of new biological tests free of charge the first time. If further testing is required, extra tests must be ordered from Safe Sterilization. They will be sent, and you will receive a separate invoice.

If you only test once a year, you are not covered by our subscription plan. Therefore, no new free of charge biological indicators are sent to you for re-test. If there is growth, you will be contacted by Safe Sterilization.

We need extra biological indicators

If the autoclave/dry sterilizer has been repaired, had a shutdown, or you are using borrowed equipment or the biological indicators have been damaged, contact Safe Sterilization to receive new biological indicators.

If you have a 12-month subscription plan, the additional biological indicators are included in the price.
If not, an additional set of biological indicators must be purchased.

How are we going to store our instruments and equipment after they have been sterilized?

Store your sterilized equipment and instruments in clean and closed cabinets and drawers protected from moisture, dust, sunlight, and temperature fluctuations. Before using instruments and equipment, make sure that the expiry date has not been exceeded and that the sterile packaging (autoclave bag) is not damaged or damp.

In the Danish “Nationale infektionshygiejniske retningslinjer” NIR, which contains recommendations regarding procedures and handling of medical devices, for dentists Appendix 1 (p. 59-60) a scoring system is described to help assess the durability of sterile packaged instruments. The giving times are only indicative. This appendix also applies to other industries.
NIR for dentists can be found here. Please consult your national standards to ensure your sterilizations processes complies with location regulations. https://hygiejne.ssi.dk/NIRTandklinikker

When can I expect to get an answer to my test?

Once we receive your biological indicators, they are immediately incubated, and the test result will be read after 4-7 days. Test results are sent as a certificate via email.
If you have chosen to receive the certificate by mail, you should expect 5-8 days delivery time.

Can I get my certificate by mail?

For an additional fee you can receive your certificate by mail.

I would like to present my certificates in the clinic. Does Safe have a picture frame for displaying the certificate?

Yes, we have. See products on the website here.

How long should we save our certificates?

Consult your national standards for documentation as to how long you are required to store all paperwork. Should you misplace a certificate, Safe Sterilization can resend certificates upon request at a small fee.

How long does Safe Sterilization archive test results?

We archive all test results for a minimum of 5 years.

I am a chiropodist; how often should I test the sterilization process in my autoclave/dry sterilizer?

Quality checks should be carried out at regular intervals, for example every 3 months, and after repairing the sterilizer. If you have a temporary sterilizer it should also be tested.
Consult your national standards as to how often you are required to verify your equipment. Read more here: http://ipaper.fodterapeut.dk/Brochurer/hygiejnevejledninger/rengoering -desinfektion-og-sterilisation-af-behandlingsinstrumenter-og-diagnosevaerktoejer/?page=10

I am a chiropodist, can you send my certificate to the association Danske fodterapeuter?

No, you will have to send the certificate to the association yourself.

Can the chemical indicators for control of steam sterilization be divided into two units?

Yes, they are designed to be cut. There is an instruction on the box itself and an indication on the chemical indicator.

What should I do with the chemical indicators after reading the result?

We recommend you to store used chemical indicators for a minimum of 3 months as documentation for daily testing. Note the date of performed test and signature on the back of the test. Fill in results in your sterilizers logbook as per internal standard.             

The chemical indicators should be stored dark and cool, without direct exposure to sunlight.

I received an invoice. What period does it cover?

The subscription period is usually from the invoice date and 12 months onwards. If a subscription is cancelled during a subscription period, no refund will be given.

A subscription can be changed when the subscription period ends unless it is an upgrade of the subscription. If you wish to change your subscription, please contact Safe in advance at to ensure the changes are in effect at the time of the new subscription period.