Every dental practice in the Netherlands must have a written reprocessing protocol. The IGJ inspector may review it during announced or unannounced visits; the IGJ Supervision Framework for Infection Prevention in Dental Care (2018) is the reference standard. In January 2026, the IGJ published additional points of attention on infection prevention in cooperation with the KNMT. This guide details what your protocol must contain and how it aligns with the KNMT guideline and the supervision framework.
In the Netherlands, every dental practice must have a written reprocessing protocol that describes the reprocessing of medical devices in detail. This protocol must be accessible to all staff and available for presentation during IGJ practice visits. The KNMT guideline on infection prevention in dental practices is the operational field standard; the Wkkgz (Care quality, complaints and disputes act) Articles 2 and 3 establish the legal obligation. The reprocessing protocol is not a poster on the wall -- it is an operational document that describes how, when, and who performs each step.
A missing or insufficient protocol is one of the most common findings during IGJ practice visits. Application of the harmonized NEN-EN standards (NEN-EN 13060, NEN-EN-ISO 15883) provides the basis for demonstrating the state of the art during inspection.
The designation of the person responsible for reprocessing under the KNMT guideline, including their qualification and training. A detailed description of each step in the reprocessing chain (pre-cleaning, machine cleaning and disinfection in a washer-disinfector per NEN-EN-ISO 15883, rinsing, drying, inspection, packaging, sterilization, release, storage). The products used at each step (trade name, concentration, contact time). The sterilization parameters of the autoclave (program, temperature, pressure, duration). The frequency and type of controls (daily Bowie-Dick/helix test, chemical indicators per load, weekly biological indicators). The procedure in case of a failed cycle or non-compliant test. The autoclave maintenance schedule (servicing, calibrations, gasket replacement). Instrument-specific reprocessing instructions for medical devices with special requirements.
The reprocessing protocol must be updated when a product, device, or procedure changes. Each update must be dated and signed by the responsible person. The KNMT guideline on infection prevention provides the current field standard for protocol drafting.
For a step-by-step breakdown of the reprocessing chain, see our dental reprocessing chain guide.
A cycle is valid when the recorded parameters match the selected program and all indicators are compliant. In Dutch dental practice, the reference cycle is 134 degrees C for 18 minutes (prion cycle). The autoclave must be class B per NEN-EN 13060 to sterilize hollow instruments (turbines, contra-angle handpieces) and wrapped loads.
Before the first load of each working day, a Bowie-Dick or helix test validates proper autoclave function. The KNMT guideline and the Spaulding classification determine the required controls: critical hollow-load instruments (turbines and contra-angle handpieces) require the helix test to validate steam penetration. A failed cycle or a non-compliant indicator requires repackaging and resterilization of the entire load.
For details on biological controls, see our autoclave biological controls guide.
The IGJ (Health and Youth Care Inspectorate) is the national supervisor that inspects dental practices. Practice visits can be announced (as part of the regular inspection calendar) or unannounced (following complaints or hygiene incidents). The IGJ Supervision Framework for Infection Prevention in Dental Care (2018) is the reference standard. The inspector checks: the existence of the reprocessing protocol, its alignment with current guidance, that staff know and follow it, that reprocessing documentation is complete and up to date, and that periodic controls (Bowie-Dick, biological controls) are performed as documented.
In January 2026 the IGJ, in cooperation with the KNMT, published additional points of attention on infection prevention in dental care. These attention points supplement the IGJ Supervision Framework for Infection Prevention in Dental Care (2018) and clarify IGJ expectations during practice visits. The most frequently flagged issues during practice visits: missing instrument-to-patient traceability, absent or incomplete reprocessing protocol, undocumented biological controls, and insufficient qualification of the person responsible for reprocessing.
The Netherlands has no analogue to the German MPBetreibV -- when implementing the Wmh, the legislator explicitly chose not to bring dental practices under Articles 6 and 7 of the Besluit medische hulpmiddelen. The explanatory memorandum to that decree (Stb. 2020, 25054) substantiates this exclusion explicitly. Dutch dental supervision operates through field standard (KNMT guideline) and supervision framework (IGJ), not through a codified regulation -- a different regulatory paradigm with the same expectation of documented practice.
The reprocessing protocol must define the traceability method used. Dutch regulation does not prescribe a format -- paper registers remain legally accepted. But their limitations are well documented: missing pages, illegible handwriting, forgotten entries, no instrument-to-patient link, risk of loss in case of disaster. For patient-record-linked sterilizations 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.
A digital register eliminates these risks. SecuSteri automatically imports the autoclave report, links each instrument to its cycle, and generates a signed, tamper-evident audit trail. Each cycle is archived according to the protocol's retention period, accessible at any time during an IGJ practice visit.
For a detailed comparison, see our digital vs paper register guide.
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