The traceability record links each sterilized instrument to its autoclave cycle, operator, and use-by date. For Luxembourg dental practices, the minimum content aligns with Regulation (EU) 2017/745 and sector best practice. For tattoo / piercing / permanent makeup studios, the Loi du 24 mai 2018 requires full traceability of services: client informed consent, ink or pigment batch numbers (REACH compliance), date, operator. SecuSteri generates these records automatically, compliant with Luxembourg requirements.
In Luxembourg, sterilization traceability is not governed by a standard form, but the requirements are clear. For tattoo artists, piercers, and permanent makeup practitioners, the Loi du 24 mai 2018 (Memorial A442) and the Règlement grand-ducal du 9 novembre 2018 (Memorial A1048) mandate documented sterilization protocols as part of the MyGuichet.lu declaration. For dental practices, the general professional duty (Loi modifiée du 29 avril 1983), the Loi modifiée du 16 janvier 1990 on medical devices, and Regulation (EU) 2017/745 expect a register linking cycles to patient records. For podiatrists — a recently regulated profession under the Loi du 29 juin 2023 (Annexe 21) — traceability of reusable medical devices is part of sector best practice.
The absence of a standard form means each professional is responsible for ensuring their record contains the necessary information. This guide details the required fields. For full regulatory requirements, see the sterilization regulations guide.
Each traceability record should contain at minimum: the date and time of the cycle, autoclave identification (name or serial number), cycle or batch number, cycle type (standard 134°C/5.5 min or prion 134°C/18 min), recorded parameters (temperature, pressure, duration), cycle result (pass or fail), identity of the operator who loaded and validated the cycle, and the list of instruments or pouches in the load.
For dental practices, sector best practice and Regulation (EU) 2017/745 add further requirements: the link to the patient record (which patient received which instruments), the day's Helix or Bowie-Dick test results, and the use-by date on each pouch. For tattoo and permanent makeup studios, the client record must also include ink and pigment batch numbers (REACH Annex XVII Entry 75 compliance). For more on the use-by date, see the use-by date guide.
A dental practice must link each cycle to the patient record — this is the strictest expectation under Regulation (EU) 2017/745 and sector best practice. Tattoo artists, piercers, and permanent makeup practitioners must document their sterilization protocols under the Loi du 24 mai 2018 and the Règlement grand-ducal du 9 novembre 2018, with a client record linking the service to ink batch numbers. Podiatrists, under the Loi du 29 juin 2023, operate within the no-blood-drawing rule: traceability remains a best practice but with lower criticality.
No retention period is codified by a specific règlement grand-ducal in Luxembourg. European sector best practice recommends retaining sterilization records for at least 5 years in dental practice. For tattoo artists, piercers, and permanent makeup practitioners, client registers and declarations must be retained in accordance with the Loi du 24 mai 2018. In case of litigation, traceability records can serve as evidence — it is therefore prudent to retain them for as long as necessary.
On paper, the record is filled in by hand after each cycle: date, time, cycle number, instrument list, signature. The risks: forgotten entries, illegible handwriting, lost binders, inability to search quickly. With a digital register like SecuSteri, the record 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 viewable during an Inspection sanitaire (Direction de la santé) visit to a dental practice, or an inspection by officers of police judiciaire at a tattoo, piercing, or permanent makeup studio.
For a detailed comparison between paper and digital registers, see our digital register guide.
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