MePV Art. 72 requires sterilization process records — date, time, cycle number, parameters (temperature, pressure, hold time), result, and the link to the instrument and patient record. The format is not prescribed; the expectation is full reconstructability of every cycle, every instrument batch, and every load during a cantonal inspection. For tattoo, piercing, and permanent makeup studios, the EDI Ordinance on objects in human contact (SR 817.023.41) and the BAG 'Good Work Practice' Directive of 16 August 2018 add ink batch numbers, single-use device batch numbers, signed informed consent with health-status declaration, and incident reporting.
In Switzerland, MePV / ODim Art. 72 expects sterilization records — date, time, cycle number, parameters (temperature, pressure, hold time), result — plus the link to the instrument and patient record. For dental practices, the GPA 2022 (Swiss Good Practice for Medical Device Reprocessing), KIGAP 2010 (status 2017), and the SSO Quality Guidelines on Practice Hygiene (2018) define expectations for format and content. The format is not prescribed; the expectation is full reconstructability of every cycle, every instrument batch, and every load during a cantonal inspection.
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 includes at minimum: sterilizer make and type designation, the sterilization process, the date and batch number, start and end times, efficacy documentation (Bowie-Dick / Helix test, chemical indicator per SN EN ISO 11140-1, biological control per SN EN ISO 11138), and release by the responsible person (signature or PIN release). Thermal validation follows SN EN ISO 17665-1. Electronic storage of process data is equivalent to a paper printout — the GPA 2022 accepts both formats, provided completeness, integrity, and availability during inspection are guaranteed.
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 (per SN EN 868 and SN EN ISO 11607). For prion-relevant procedures, the cycle 134°C / 18-minute label per CJKV (SR 818.101.21). For details on use-by dates, see the use-by date guide.
Dental practices: traceability must enable the link between an instrument and the patient on whom it was used. This requires documentation tying the sterilization cycle (date, batch number), the instruments in the batch, and the patient record together. 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 — the expectation flows from MePV / ODim Art. 72 and the GPA 2022.
Tattoo, piercing, and permanent makeup: for tattoo, piercing, and permanent makeup studios, the EDI Ordinance on objects in human contact (SR 817.023.41) and the BAG 'Good Work Practice' Directive of 16 August 2018 round out the requirements — ink batch numbers, single-use devices, signed informed consent with health declaration, and incident reporting. The activity must also be notified to the cantonal enforcement authority under Art. 62 LGV (federal cantonal notification since 1 May 2017, fully binding since 1 May 2018). SN EN 17169:2020 (Tattooing — Safe and Hygienic Practice) is the European reference standard. REACH Annex XVII Entry 75 prohibits Pigment Blue 15:3 and Pigment Green 7 since 1 February 2025 (transposed via the 8 December 2023 EDI amendment). The pouch is opened in front of the client, and it is documented which instruments were used in each session.
Veterinary practices: in Switzerland, there is no federal autoclave mandate for veterinary practices — the BLV / OSAV framework and the GST Code of Professional Conduct 2022 apply as the professional framework. KIGAP explicitly does NOT name veterinary practices among its user groups. Sterilization documentation is good practice in the interest of care quality and civil liability.
Podiatry: podiatry in Switzerland is regulated under the EFZ Ordinance for Podologist (SR 412.101.220) and the SBFI Framework Curriculum Podologie HF of 7 February 2022 — sterilization is codified as a core HF competency. KIGAP explicitly names podologists among the user groups of small steam sterilizers. Reprocessing is carried out exclusively by qualified personnel.
Switzerland has no codified retention period in MePV for reprocessing documentation. The GPA 2022 and KIGAP recommend alignment with SN EN 868 (packaging) and SN EN ISO 11607 (packaging validation) plus long-term archival for civil-liability purposes — the SSO Quality Guidelines on Practice Hygiene (2018) envision a multi-year horizon covering civil prescription periods. For tattoo, piercing, and permanent makeup studios, client records and incident reports must be available for review by the cantonal enforcement authority during an inspection. 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 a Kantonsarztamt / Service du médecin cantonal inspection or a cantonal enforcement check.
For a detailed comparison between paper and digital registers, see our digital register guide.
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