Validation

I am in Austria / Germany. Do I need to validate my autoclave?

All users who prepare instruments in human medicine (podiatry, beauty, tattoo studios, doctors, clinics...) are required to have their autoclave validated. The basis for the obligation to validate in instrument preparation is § 8 of the Medical Devices Operator Ordinance (MPBetreibV): Validation is carried out on-site every 24 months according to the national standard DIN SPEC 58929.

You can order the initial validation in our shop (all-inclusive package price).
Please note that the autoclave must be revalidated every 2 years.

Tip: Sign a validation contract with us. We will ensure that your autoclave is always revalidated and ready for use. When you sign a validation contract, you will also receive a price advantage of 40 EUR per revalidation due to better planning for on-site validation.

Statement from AGES:

Healthcare facilities, including private dentists, are obligated under § 62 of the Medical Devices Act 2021 to carry out the cleaning, disinfection, and sterilization of medical devices using appropriate validated procedures, ensuring the success of these procedures is traceably guaranteed. A validated (reprocessing) procedure requires properly qualified/validated devices (such as cleaning and disinfection devices, autoclaves). Without prior device qualification/validation, the goal of validated procedures, namely to consistently produce products (in this case, sterile medical devices) that meet the specified specifications, cannot be traceably guaranteed.
This requirement is also reflected in various national guidelines, such as in section 6.6 "Small Sterilizers" of the ÖGSV (Austrian Society for Sterile Supply) -LL 06-FK-2 (https://oegsv.com/wp/wp-content/uploads/06-FK-2_-Pruefung-und-Validierung-von-Aufbereitungsverfahren_2016.pdf) or the Krinko BfArM recommendation, Bundesgesundheitsbl 2012 · 55:1244–1310, on p. 1251, third column.

I am in Switzerland. Do I need to validate my autoclave?

All users who prepare instruments in human medicine (podiatry, beauty, tattoo studios, doctors, clinics...) are required to have their autoclave validated. The basis for the obligation to validate in instrument preparation is the Medical Devices Operator Ordinance (MPBetreibV). Validation is carried out on-site every 24 months according to the recommendations of Swissmedic and is not included in the maintenance offer.

You can order the initial validation in our shop (all-inclusive package price).
Please note that the autoclave must be revalidated every 2 years.

Tip: Sign a validation contract with us. We will ensure that your autoclave is always revalidated and ready for use. When you sign a validation contract, you will also receive a price advantage of 40 EUR per revalidation due to better planning for on-site validation.

All details regarding the requirements for healthcare facilities for instrument preparation can be found here: Reprocessing (swissmedic.ch) or contact us.

In Switzerland, at least one employee in the practice or clinic must be trained in instrument preparation. The following training courses are approved and recognized in Switzerland:

1. H+ Education Course
2. Expertise Course 1, 2, 3 
3. DSGVO Expertise and Knowledge Courses