Sterilization regulations in the Netherlands: what the law requires

Who is required to sterilize instruments?

In the Netherlands, the Wkkgz (Care quality, complaints and disputes act) Articles 2 and 3 set the general duty of care, and the Wmh (Medical devices act, BWBR0042755) together with the Besluit medische hulpmiddelen (BWBR0043470, Stb. 2020, 130) implement EU Regulation 2017/745 nationally. Dental practices are directly affected: all reusable instruments that penetrate the skin or contact mucous membranes must be reprocessed and sterilized following a validated procedure. The KNMT guideline on infection prevention in dental practices and the IGJ Supervision Framework for Infection Prevention in Dental Care (2018) are the authoritative field standards.

Tattoo artists, piercers, and permanent makeup practitioners fall under the Warenwetbesluit on tattooing and piercing (BWBR0021605, Stb. 2007, 114) and the LCHV hygiene guidelines. Every studio needs a three-year permit from one of the 25 GGD regions; the NVWA exercises national supervision on inks and colorants under REACH Annex XVII Entry 75. Podiatrists are protected Wet BIG Article 34 healthcare professionals operating under the NVvP practice guideline on hygiene and infection prevention 2021 and -- since 26 January 2026 -- the IGJ Supervision Framework for Paramedical Care. The principle is uniform: any reusable instrument that breaches the skin barrier or contacts blood or mucous membranes must be sterilized before each use.

NEN-EN 13060: small steam sterilizers

NEN-EN 13060 is the Dutch adoption of the European standard EN 13060, defining requirements for small steam sterilizers used in practices and studios. It distinguishes three autoclave classes: class N (solid, unwrapped instruments only), class S (specific cycles defined by the manufacturer), and class B (the most versatile -- hollow instruments, wrapped loads, textiles). The KNMT guideline on infection prevention uses a Spaulding risk classification (critical, semi-critical, non-critical). For critical hollow-load instruments (e.g., instruments with lumens), a class B autoclave and prior machine cleaning and disinfection in a washer-disinfector per NEN-EN-ISO 15883 are required.

Regulatory bodies

Dental -- IGJ and KNMT: the IGJ (Health and Youth Care Inspectorate) is the national supervisor for dental care and conducts announced and unannounced practice visits. The KNMT (Royal Dutch Society for the Advancement of Dentistry) maintains the operational field standard -- the guideline on infection prevention in dental practices. The IGJ Supervision Framework for Dental Care (2018) is the basis for inspection; in January 2026, the IGJ in cooperation with the KNMT published additional points of attention on infection prevention. Dutch regulation is nationally uniform -- there is a single central supervisor for dental care, with no regional variation.

Tattoo, piercing, and permanent makeup: the Warenwetbesluit on tattooing and piercing (BWBR0021605) governs the permit obligation. NEN-EN 17169:2020 has been designated as the safety code since 1 May 2022 (Stcrt. 2022, 4132). The LCHV hygiene guidelines for tattooing and piercing are the operational reference documents; RIVM publishes the explanatory notes on NEN-EN 17169. Permitting runs through one of the 25 GGD regions; the NVWA exercises national supervision on inks and colorants.

Podiatry: podiatrists are protected Wet BIG Article 34 healthcare professionals, registered in the Kwaliteitsregister Paramedici (CIBG). They operate under the NVvP practice guideline on hygiene and infection prevention 2021 and the NVvP practice quality mark. Since 26 January 2026, podiatrists fall formally under the IGJ Supervision Framework for Paramedical Care. The framework assesses five themes: person-centered care, collaboration, quality policy, personnel policy and recordkeeping -- infection prevention sits under quality policy. This is the first time podiatry falls formally under structured IGJ supervision.

What an inspector checks during a practice visit

During an IGJ practice visit or a GGD inspection, the following points are assessed: presence of a written reprocessing protocol, complete batch documentation with date, time, parameters and instrument linkage, daily Bowie-Dick or helix test before the first load (KNMT guideline on infection prevention), periodic biological controls using Geobacillus stearothermophilus, proper waste management per national regulations, staff qualification documentation, and structured maintenance records for reprocessing equipment. For patient-record-linked sterilizations the 20-year WGBO retention applies (BW Article 7:454).

Penalties for non-compliance

Wkkgz Article 11 and Wet BIG Article 96: structural shortcomings in the quality of care can be sanctioned by the IGJ via an aanwijzing (formal direction) or a last onder dwangsom (cease-and-desist order with penalty). In serious cases a disciplinary proceeding may be initiated through the regional disciplinary tribunals. The Stichting Zorggeschil -- VWS-recognized -- handles patient complaints about care providers.

Tattoo, piercing, and permanent makeup: studios operating without a valid GGD permit or with serious hygiene shortcomings risk withdrawal of the permit and administrative sanctions. NVWA supervision reports for 2024 show that roughly half of unannounced tattoo studio inspections found one or more shortcomings. Refusing cooperation during a GGD or NVWA inspection is treated as a serious violation.

Podiatry: podiatry practices fall under the same sanction framework as other care providers under the Wkkgz. In addition, the IGJ can exercise structured supervision via the Supervision Framework for Paramedical Care (since 26 January 2026) on infection prevention within the quality-policy theme. Application of the harmonized NEN-EN standards provides the basis for demonstrating the state of the art during an IGJ practice visit.