Anlage 1 of the ÖZÄK-Hygieneverordnung 2025 defines the mandatory minimum format of the sterilization documentation form: sterilizer make/type, sterilization process, date, batch number, start/end, signature, efficacy documentation. The retention period is 7 years (§ 6 Abs. 3). For tattoo/piercing/PMU businesses, § 5 ARPTV requires 10-year retention for client consents and ink batch numbers. SecuSteri generates compliant records automatically.
In Austria, complete traceability of medical device reprocessing is a legal obligation. For dental practices, Anlage 1 of the ÖZÄK-Hygieneverordnung 2025 (in force since 1 May 2025) defines the mandatory minimum format of the sterilization documentation form (Dokumentationsblatt Sterilisation): for every batch, it must be possible to determine which parameters were used, who released the cycle, and whether the result met specifications. § 6 Abs. 3 ÖZÄK-HygV 2025 requires a 7-year retention period.
The traceability sheet is the central document of this system: it consolidates all information from a sterilization cycle into a searchable and archivable format. Without it, there is no traceability -- only scattered data points. For full regulatory requirements, see the sterilization regulations guide.
A complete batch documentation per Anlage 1 ÖZÄK-HygV 2025 includes at minimum: sterilizer make and type designation, the sterilization process, the date and Sterilisationschargennummer (batch number), start and end times, efficacy documentation (Bowie-Dick/Helix test, chemical indicator, biological control), and the signature of the releasing person. § 20 Abs. 5 ÖZÄK-HygV 2025 explicitly accepts electronic storage of pressure and temperature as equivalent to paper printout.
For dental practices, additional fields are recommended: the link to the patient record (which patient received which instruments), the daily Helix or Bowie-Dick test results, and the use-by date (Verfallsdatum) marked on each pouch -- with a maximum 6-month sterile-storage limit for Anlage 2 Categories C and D. For details on use-by dates, see the use-by date guide.
Dental practices (Ordinationen) have the strictest traceability requirements -- the instrument-to-patient link is expected, particularly for Anlage 2 Category C (endodontic / penetrating mucosa) and Category D (oral surgery) procedures. In the event of a health alert (e.g., a patient diagnosed with hepatitis), the practice must be able to identify all patients who came into contact with instruments from the same batch.
Tattoo, piercing, and permanent makeup studios must maintain a Hygieneplan, client documentation (name, date, informed consent, ink batch numbers) and sterilization records under the federal-uniform ARPTV (BGBl. II Nr. 141/2003) and ARFKMV (BGBl. II Nr. 262/2008). The retention period is 10 years (§ 5 ARPTV). Instrument-to-client traceability is required: the pouch is opened in front of the client, and it is documented which instruments were used in each session. This documentation is the core of the annual Unbedenklichkeitsnachweis (UbN) under § 4 ARFKMV.
Veterinary practices (Ordinationen) have required a sterilizer or autoclave as mandatory minimum equipment since 6 December 2022 under § 4 Abs. 1 Z 2 lit. h Ordinationsrichtlinie of the Österreichische Tierärztekammer (OrdiRL 2022). The batch documentation links the sterilization cycle to the treated animals -- and concerns sterilization of the surgical instrumentation (not the surgical sterilization of animals themselves).
Foot care (Fußpflege) operates as a licensed trade under § 94 Z 23 GewO 1994 in Austria -- the regulated healthcare profession of "Podologe/Podologin" does not exist here. Anlage 1 ARFKMV's general hygiene requirements apply; the ÖGSV-Stellungnahme S-08 (2017) is the technical best-practice reference for the reprocessing of foot care instruments.
Dental practices must retain all hygiene documentation for 7 years per § 6 Abs. 3 ÖZÄK-HygV 2025 -- longer than the general MPBV retention period. Tattoo, piercing, and permanent makeup studios must retain client and ink-batch records for 10 years per § 5 ARPTV. Veterinary practices follow the patient record-keeping obligations under TÄG. The practical recommendation: retain all records as long as possible -- a digital register has no storage limitations.
On paper, the record is filled in by hand after each cycle: date, time, batch number, instrument list, signature. The risks: forgetting to fill it in, illegible handwriting, lost binders, no quick search capability. With a digital register like SecuSteri, the traceability sheet is generated automatically from the imported autoclave report. The operator signs the cycle with their PIN code, the instruments in the load are linked to the cycle, and a QR label is printed for each pouch. The complete record is instantly accessible during an Ordinationsüberprüfung by the Bezirksverwaltungsbehörde or the annual UbN inspection.
For a detailed comparison between paper and digital registers, see our digital register guide.
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