The KNMT guideline on infection prevention in dental practices and the NVvP practice guideline on hygiene and infection prevention 2021 define the required fields for sterilization records: date, sterilizer identification, program, batch number, test results and release signature. For patient-record-linked sterilizations the 20-year WGBO retention period applies (BW Article 7:454). This guide details the required fields by profession and how SecuSteri automatically generates compliant records.
In the Netherlands, complete traceability of medical device reprocessing is a legal obligation. The Wkkgz (Care quality, complaints and disputes act) Articles 2 and 3 require care providers to deliver good care, organized with personnel and material resources that reasonably lead to good care. The KNMT guideline on infection prevention in dental practices and the NVvP practice guideline on hygiene and infection prevention 2021 define the requirements for batch documentation: for every sterilization cycle, it must be possible to determine which instruments were processed with which parameters, who released the cycle, and whether the result met specifications. For patient-record-linked sterilization data the 20-year WGBO retention applies (BW Article 7:454, in force since 1 January 2020).
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.
Every traceability sheet should include at minimum: the date and time of the cycle, autoclave identification (serial number or name), the batch number, the cycle program (e.g., 134 degrees C / 5.5 min standard or 134 degrees C / 18 min prion cycle), the recorded parameters (temperature, pressure, duration), the cycle result (pass or fail), process indicators (Bowie-Dick, chemical integrator, biological indicator), the list of instruments in the load, operator identification, and release by signature or electronic validation.
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 marked on each pouch. For details on use-by dates, see the use-by date guide.
Dental practices have the strictest traceability requirements -- the instrument-to-patient link is expected, particularly for surgical and endodontic 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 hygiene and infection-prevention plan, client documentation (name, date, informed consent), and sterilization records under the Warenwetbesluit on tattooing and piercing (BWBR0021605) and the LCHV hygiene guidelines. 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.
Podiatry occupies the same regulatory position as dental practice: as a protected Wet BIG Article 34 profession, podiatry practices must demonstrate full traceability during IGJ practice visits, applying the NVvP practice guideline on hygiene and infection prevention 2021 and -- since 26 January 2026 -- the IGJ Supervision Framework for Paramedical Care.
For patient-record-linked sterilization data the 20-year WGBO retention applies (BW Article 7:454, in force since 1 January 2020) -- the longest retention period for sterilization documentation in any European market where SecuSteri operates. For tattoo and piercing studios shorter periods may suffice, but the practical recommendation is the same: retain all records as long as possible -- a digital register has no storage limitations, unlike a paper archive.
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. Over a 20-year retention horizon these risks compound. 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 inspection.
For a detailed comparison between paper and digital registers, see our digital register guide.
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