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.
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.
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.
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.
Dry heat sterilization:
NB. It is important that the sterilization time is counted from the time the specified temperature is obtained in the sterilizer.
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.
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.
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.
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
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.
For an additional fee you can receive your certificate by mail.
Yes, we have. See products on the website here.
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.
We archive all test results for a minimum of 5 years.
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
No, you will have to send the certificate to the association yourself.
Yes, they are designed to be cut. There is an instruction on the box itself and an indication on the chemical indicator.
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.
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.