Every dental practice in Austria has been required since 1 May 2025 to maintain a reprocessing protocol per § 5 record-keeping obligations of the ÖZÄK-Hygieneverordnung 2025 — including a Hygieneplan and cleaning/disinfection plan in the mandatory minimum format of Anlage 1. The Bezirksverwaltungsbehörde checks these during Ordinationsüberprüfungen under § 36 Abs. 2 ZÄG. Class B sterilizer and washer-disinfector become mandatory for existing practices by 1 May 2028 (§ 24 Abs. 3). This guide details what your protocol must contain.
In Austria, every dental practice (Ordination) has been required since 1 May 2025 to maintain a written Hygieneplan that describes the reprocessing of medical devices in detail. The plan follows the mandatory minimum format of Anlage 1 ÖZÄK-Hygieneverordnung 2025 -- together with the cleaning and disinfection plan, also prescribed in Anlage 1. Both must be accessible to all staff and available for presentation during Ordinationsüberprüfungen by the Bezirksverwaltungsbehörde under § 36 Abs. 2 ZÄG. § 5 record-keeping obligations of the ÖZÄK-HygV 2025 establishes the legal obligation; ÖGSV-Leitlinie 11 (2024) provides the technical foundation. The hygiene plan is not a simple poster on the wall -- it is an operational document that describes how, when, and who performs each step.
Its absence or insufficiency is one of the most common findings during inspections. Compliance with recognized standards (ÖNORM EN 13060:2025-10-15, ÖNORM EN ISO 15883) is the prerequisite for proper reprocessing. The ÖZÄK-Hygieneverordnung 2025 makes the Anlage 1 minimum format binding; § 24 Abs. 3 sets 1 May 2028 as the deadline for Class B sterilizer + washer-disinfector in existing practices. Complete documentation is the foundation of every Ordinationsüberprüfung by the Bezirksverwaltungsbehörde -- not "we assume it is proper," but a demonstrable reprocessing practice.
The designation of the medical-device reprocessing supervisor under MPBV, including their Sachkenntnisnachweis (proof of expertise per ÖGSV-Leitlinie 11). A detailed description of each step in the reprocessing chain (pre-cleaning, machine cleaning and disinfection in a washer-disinfector per ÖNORM EN ISO 15883, rinsing, drying, inspection, packaging, sterilization, release, storage). The products used at each step (trade name, concentration, contact time). The sterilization parameters of the autoclave (program, temperature, pressure, duration -- 134°C / 3 min OR 121°C / 15 min per § 20 Abs. 5 ÖZÄK-HygV 2025). The frequency and type of controls (daily Bowie-Dick/Helix test, chemical indicators per load, regular biological indicators). The risk classification per Anlage 2 (assignment of practice-relevant procedures to Categories A/B/C/D). The procedure in case of a failed cycle or non-compliant test. The autoclave maintenance schedule (servicing, calibrations, gasket replacement). Instrument-specific reprocessing instructions per ÖNORM EN ISO 17664 (manufacturer information).
The hygiene plan must be updated when a product, device, or procedure changes. Each update must be dated and signed by the responsible person. ÖGSV-Leitlinie 11 (2024) provides current guidance for creating the plan.
For a step-by-step breakdown of the reprocessing chain, see our dental reprocessing chain guide.
A cycle is valid when the recorded parameters match the selected program and all indicators are compliant. In Austrian dental practice, the reference cycle is 134°C / 3 min OR 121°C / 15 min per § 20 Abs. 5 ÖZÄK-HygV 2025. § 20 Abs. 5 explicitly accepts electronic storage of pressure and temperature as equivalent to paper printout. The autoclave must be Class B per ÖNORM EN 13060:2025-10-15 to sterilize hollow instruments (turbines, contra-angles) and wrapped loads -- already mandatory now for Anlage 2 Category D procedures, mandatory for all existing practices by 1 May 2028 (§ 24 Abs. 3).
Before the first load of each working day, a Bowie-Dick test or Helix test validates proper autoclave function. Anlage 2 ÖZÄK-HygV 2025 determines the required reprocessing method per procedure type; hollow instruments (turbines, contra-angles) require the Helix test to validate steam penetration into channels. A failed cycle or a non-compliant indicator requires repackaging and resterilization of the entire load. Annual performance qualification per ÖNORM EN ISO 17665-1 is best practice; external validation under § 22 ÖZÄK-HygV 2025 is required only on official authority order.
For details on biological controls, see our autoclave biological controls guide.
The Bezirksverwaltungsbehörde (Bezirkshauptmannschaft outside statutory cities; Magistrat in Vienna and other Statutarstädte) conducts Ordinationsüberprüfungen under § 36 Abs. 2 ZÄG. Inspections can be scheduled (as part of the regular inspection calendar) or unannounced (following complaints or hygiene incidents). The inspector checks: the existence of the Hygieneplan in the Anlage 1 minimum format, its compliance with current regulations, that staff know and follow it, that reprocessing documentation is complete and up to date, and that periodic controls (Bowie-Dick, biological controls) are performed as documented.
The competent Landeszahnärztekammer can also conduct quality reviews and handles complaints regarding practice hygiene. Disciplinary jurisdiction lies with the Disziplinarrat der Österreichischen Zahnärztekammer under § 62 ZÄKG. The qualification of the responsible person under MPBV is particularly scrutinized -- ÖGSV-Leitlinie 11 (2024) defines the required expertise for reprocessing medical devices in dental practice. The most frequently flagged issues during inspections: missing instrument-to-patient traceability, absent or incomplete Hygieneplan, undocumented biological controls, and insufficient qualification of the person responsible for reprocessing.
The hygiene plan must define the traceability method used. Anlage 1 ÖZÄK-HygV 2025 prescribes the minimum format for the sterilization documentation form, while § 20 Abs. 5 explicitly accepts electronic storage as equivalent to paper printout. Paper registers remain legally accepted, but their limitations are well documented: missing pages, illegible handwriting, forgotten entries, no instrument-to-patient link, risk of loss in case of disaster. Under § 6 Abs. 3 ÖZÄK-HygV 2025, all records must be retained for 7 years -- longer than the general MPBV retention period.
A digital register eliminates these risks. SecuSteri automatically imports the autoclave report, links each instrument to its cycle, and generates a signed, tamper-proof record. Each cycle is archived according to the plan's retention period, accessible at any time during an inspection.
For a detailed comparison, see our digital vs paper register guide.
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