Sterilization traceability is not just record-keeping — it's a legal obligation with precise requirements. SecuSteri is designed to meet them.
In Austria, federal-uniform regulations govern the reprocessing of medical devices across all professions that use reusable instruments. Dental practices have been subject to the ÖZÄK-Hygieneverordnung 2025 since 1 May 2025: Anlage 1 makes the minimum format of the Hygieneplan and cleaning/disinfection plan binding; Anlage 2 assigns each procedure to one of 4 risk categories (A/B/C/D); § 24 Abs. 3 sets 1 May 2028 as the deadline for existing practices to install a Class B sterilizer + washer-disinfector (RDG); § 6 Abs. 3 requires 7-year retention. Tattoo, piercing, and permanent makeup studios are governed federal-uniform by the ARPTV (BGBl. II Nr. 141/2003) and ARFKMV (BGBl. II Nr. 262/2008): § 4 ARFKMV requires an annual Unbedenklichkeitsnachweis (UbN) issued by an Akkreditierung Austria-accredited body, § 5 ARPTV requires 10-year retention, Anlage 1 ARFKMV requires Hepatitis B vaccination. Foot care (Fußpflege) is a licensed trade under § 94 Z 23 GewO 1994 with Anlage 1 ARFKMV hygiene rules — a Podologengesetz like in Germany does not exist in Austria. Veterinary practices fall under OrdiRL 2022: § 4 Abs. 1 Z 2 lit. h has made a sterilizer or autoclave mandatory minimum equipment since 6 December 2022. ÖNORM EN 13060:2025-10-15 defines the technical requirements for small steam sterilizers (Class B, S, and N). SecuSteri covers the documentation obligations of every regulated profession in Austria.
The ÖZÄK-Hygieneverordnung 2025 requires complete batch documentation (Chargendokumentation) for each sterilization cycle through § 5 record-keeping obligations and the binding Anlage 1 minimum format, demonstrating that parameters have been met. During an Ordinationsüberprüfung by the Bezirksverwaltungsbehörde under § 36 Abs. 2 ZÄG, the quality of this documentation is reviewed. SecuSteri generates a traceability record for each batch, digitally released by the operator with their personal PIN code. Once released, the record is locked — no modifications are possible. It is the digital equivalent of a dedicated sterilization register, without the risks of fading thermal printouts or illegible handwriting.
ÖGSV-Leitlinie 11 (2024) and Anlage 2 ÖZÄK-HygV 2025 (4-tier risk classification A/B/C/D) require seamless traceability from the autoclave to the patient — particularly for Category C procedures (pulp contact) and Category D procedures (oral surgery), which additionally have a maximum 6-month sterile-storage limit. SecuSteri goes further: every sterilized instrument is linked to its batch, operator, container, and use-by date. The traceability chain is complete and verifiable — from the sterilization cycle to the patient record.
Every significant action in SecuSteri is recorded in a tamper-proof audit trail: who did what, when, and on which record. This trail is append-only — technically impossible to modify or delete, even by an administrator. In the event of an Ordinationsüberprüfung by the Bezirksverwaltungsbehörde, or a disciplinary proceeding before the Disziplinarrat der Österreichischen Zahnärztekammer (§ 62 ZÄKG) or the Disziplinarkommission der Tierärztekammer (§ 66 TÄKamG), the complete history of operations is available.
Each operator releases batches with their personal 4-digit PIN code. This release individually identifies the person responsible for validating the batch — essential for personal liability. The PIN is stored as a cryptographic hash (bcrypt) — even the SecuSteri administrator cannot read it.
ÖGSV-Leitlinie 11 (2024) and ÖNORM EN 13060:2025-10-15 require three levels of control: physical (cycle parameters), chemical (indicators), and biological (spore tests). § 20 Abs. 5 ÖZÄK-HygV 2025 explicitly accepts electronic storage of pressure and temperature as equivalent to paper printout. SecuSteri tracks all autoclave checks — vacuum test, Bowie-Dick, Helix, biological controls — linked to each device, with date and result. During an Ordinationsüberprüfung, the complete check history for each autoclave is available instantly.
Dental practices must retain hygiene documentation for 7 years per § 6 Abs. 3 ÖZÄK-HygV 2025; tattoo, piercing, and PMU studios must retain client and ink-batch records for 10 years per § 5 ARPTV. SecuSteri automatically retains your data according to your plan duration: 5 years (Standard), 10 years (Pro), unlimited (Clinic+). No risk of loss, fire, or water damage. Your sterilization documentation is always accessible — whether for a Bezirksverwaltungsbehörde Ordinationsüberprüfung, a disciplinary proceeding, or your own quality assurance.
Your data is hosted in the European Union on the Scaleway infrastructure in Paris. Austria, as an EU member state, is fully covered by the DSGVO (Datenschutz-Grundverordnung — General Data Protection Regulation). EU hosting meets all data residency requirements. The transfer between your browser and our servers is encrypted (TLS). Data at rest is encrypted. SecuSteri is GDPR compliant: right of access, right to data portability, right to erasure. Your data never leaves the EU. We never sell your data and never use it for advertising.
You can request a complete export of all your data (batches, instruments, autoclaves, audit trail) as a zipped CSV archive, delivered by email. The export covers your plan's retention window. Your data belongs to you — you can retrieve it at any time.
The paper register remains the standard in many Austrian practices. But paper records present documented risks: missing pages, illegible handwriting, forgotten entries after a rushed cycle, inability to search quickly, and no backup in case of disaster. Thermal printouts from autoclaves fade over time — a serious problem given the 7-year retention requirement (§ 6 Abs. 3 ÖZÄK-HygV 2025) and the 10-year retention requirement for tattoo/piercing/PMU studios (§ 5 ARPTV). Austria operates under a federally uniform framework: 9 Bundesländer, one nationwide regulation. For dental practices, ZÄKG § 58 Abs. 1 disciplinary penalties apply: monetary penalty up to €40,000 + removal from the dental register + Disziplinarrat ÖZÄK proceedings; for tattoo, piercing, and PMU studios, GewO 1994 § 366 administrative fines up to €3,600 + revocation of the Gewerbeberechtigung apply if the UbN is not presented; for veterinary practices, TÄKamG § 64 disciplinary penalties apply. Practices that maintain their reprocessing documentation per Anlage 1 ÖZÄK-HygV 2025 are ready for the next Ordinationsüberprüfung by the Bezirksverwaltungsbehörde — and meet the 1 May 2028 Class B + washer-disinfector deadline on time. SecuSteri eliminates the risks of paper records while meeting the same professional obligations.
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