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.

Hvordan skal de biologiske indikatorer placeres i autoklaven/tørsterilisatoren?

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?

Nej, posens formål er at beskytte den biologiske indikator imod forurening af fremmede mikroorganismer. Bakteriesporenes resistens (D-værdi) overfor varmepåvirkningen (damp/tør varme), er bestemt ved opbevaring i den lille pose.

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. Det er vigtigt, at sterilisationstiden først regnes fra det tidspunkt, den specificerede temperatur er opnået i sterilisatoren.

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?

Det anbefales, at de biologiske indikatorer anvendes, hvis du bruger et låneudstyr (autoklave/tørsterilisator). Ifølge “Nationale infektionshygiejniske retningslinjer” (NIR) skal låneudstyr også testes inden brug. Ret blot maskinens navn på labelerne på de biologiske indikatorer. Husk at notere at det er et låneudstyr.

Når autoklaven/tørsterilisatoren kommer retur efter reparation, skal udstyret testes med biologiske indikatorer, inden det anvendes.

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.

Ved andre abonnementstyper (f.eks. fire gange årligt), modtager I ét nyt sæt biologiske indikatorer til fornyet test uden beregning, første gang der er vækst. Ved behov for flere biologiske indikatorer, skal disse bestilles hos Safe Sterilization, hvormed de vil blive fremsendt og faktureret separat.

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

Hvis autoklaven/tørsterilisatoren har været til reparation, haft driftstop, ved anvendelse af låneudstyr eller de biologiske indikatorer er blevet ødelagt, skal du kontakte Safe Sterilization for at få tilsendt nye biologiske indikatorer.

Hvis du har et abonnement med ét sæt biologiske indikatorer 12 gange årligt (Abonnement A), er de ekstra biologiske indikatorer inkluderet i prisen. Hvis ikke, skal der tilkøbes et ekstra sæt biologiske indikatorer.

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

Det anbefales at opbevare steriliseret udstyr og instrumenter i rene og lukkede skabe/skuffer beskyttet mod fugt, støv, sollys og temperatursvingninger. Før anvendelse af instrumenter og udstyr kontrolleres det, at udløbsdatoen ikke er overskredet, samt sterilemballagen (autoklaveposen) ikke er beskadiget eller fugtig.

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 tandlæger kan findes here.

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.
Har du valgt at modtage certifikatet via post, skal du forvente en leveringstid på yderligere 5-8 arbejdsdage.

Can I get my certificate by mail?

Ja. Normalt fremsender vi certifikatet via e-mail, men mod et ekstra gebyr kan du få tilsendt dit certifikat via post. Forvent en leveringstid på 5-8 arbejdsdage.

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.

Hvor lang tid arkiverer Safe Sterilization testresultater?

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?

Nej. Du skal selv sørge for at sende dit certifikat til foreningen. Vi sender kun certifikatet til den adresse, du oplyser. Det er for din sikkerheds skyld.

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?

Vi anbefaler, at de brugte kemiske indikatorer gemmes i minimum 3 måneder som dokumentation for daglig test. Notér signatur og dato for udførelse på bagsiden af din test. Vi anbefaler, at du fører en logbog over samtlige sterilisationsprocesser inkl. resultater af test med kemiske/biologiske indikatorer.             

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.

Et abonnement kan ændres, når abonnementsperioden udløber, medmindre det er en opgradering af abonnementet. Kontakt os gerne inden dit nuværende abonnement udløber, så din nye aftale er på plads til opstart straks.