The KRINKO/BfArM Recommendation 2012 defines the requirements for batch documentation: date, sterilizer identification, program, batch number, test results, and release. The MPBetreibV requires 5-year retention. This guide details the required fields and how SecuSteri generates compliant records automatically.
In Germany, complete traceability of medical device reprocessing is a legal obligation. The 2012 KRINKO/BfArM recommendation defines the requirements for batch documentation (Chargendokumentation): 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. The Medical Devices Operator Ordinance (MPBetreibV) mandates a minimum retention period of 5 years.
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 (Chargennummer), 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 (Freigabe) 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 (Verfallsdatum) 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 make-up studios must maintain a hygiene plan (Hygieneplan), client documentation (name, date, informed consent), and sterilization records under the applicable state hygiene ordinance (Landeshygieneverordnung) and the Infection Protection Act (IfSG). 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 practices: as a healthcare profession regulated under the Podiatrists Act (PodG) and the MPBetreibV, podiatry practices must demonstrate full traceability during Gesundheitsamt inspections.
The MPBetreibV mandates a minimum retention period of 5 years for batch documentation. For dental and podiatry practices as healthcare facilities, state-level regulations on patient record retention may additionally apply -- typically 10 years after the last treatment. For tattoo and piercing studios, the retention periods of the applicable state hygiene ordinance apply. 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 inspection.
For a detailed comparison between paper and digital registers, see our digital register guide.
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