Sterilization regulations in Germany are based on the MPBetreibV for medical devices and IfSG §36 for facilities subject to hygiene surveillance. Each of the 16 Bundesländer has its own Hygieneverordnung. This guide summarizes the applicable laws, enforcement bodies, and penalties — from dental practices to tattoo studios.
In Germany, the Medizinprodukte-Betreiberverordnung (MPBetreibV, 2025 -- Medical Devices Operator Ordinance) governs the reprocessing of medical devices in Section 8. 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 KRINKO/BfArM Recommendation of 2012 (Commission for Hospital Hygiene and Infection Prevention / Federal Institute for Drugs and Medical Devices) provides the authoritative guidance for all healthcare facilities.
Tattoo artists, piercers, and permanent makeup practitioners fall under the Infektionsschutzgesetz (IfSG -- Infection Protection Act) Section 36(2) and the Hygieneverordnungen (hygiene ordinances) of each of Germany's 16 Bundeslaender (federal states). The local Gesundheitsamt (public health office) conducts regular Praxisbegehungen (practice inspections). Podiatrists are regulated as a healthcare profession under the Podologengesetz (PodG, 2001 -- Podiatrists Act) and are also subject to the MPBetreibV. The principle is universal: any reusable instrument that breaches the skin barrier or contacts blood or mucous membranes must be sterilized before each use.
DIN EN 13060 is the German 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 KRINKO risk classification categorizes medical devices into Unkritisch (non-critical), Semikritisch (semi-critical), Kritisch A (critical A), and Kritisch B (critical B). Kritisch-B instruments (those with lumens, e.g., dental turbines) require a Class B autoclave and machine cleaning/disinfection (RDG -- Reinigungs- und Desinfektionsgeraet) per DIN EN ISO 15883.
Dental -- Landeszahnaerztekammern and Gesundheitsaemter: The Landeszahnaerztekammern (state dental chambers) oversee hygiene standards in dental practices. The Gesundheitsaemter (public health offices) across Germany's 16 Bundeslaender conduct practice inspections -- announced or unannounced. Each state's Hygieneverordnung (e.g., Bavaria's LGL guidance, Berlin's Gesundheitsamt directives, Saxony-Anhalt's Rahmenhygieneplan) specifies local requirements beyond the federal framework. The DAHZ Hygieneleitfaden (16th edition, 2024 -- Dental Hygiene Guidelines) is the authoritative practice recommendation for dental offices.
Tattoo, piercing, and permanent makeup: State-level Hygieneverordnungen regulate hygiene requirements. DIN EN 17169:2020 defines the state of the art for tattoo and piercing studios. The DOT e.V. (Deutsche Organisierte Taetowierer -- German Organized Tattoo Artists) provides industry hygiene guidelines. Registration is with the local Gesundheitsamt.
Podiatry: Podiatrists are regulated as a healthcare profession under the Podologengesetz (PodG, 2001) and the MPBetreibV. Practices are inspected by the Gesundheitsamt. The BioStoffV (Biological Agents Ordinance) and TRBA 250 (Technical Rules for Biological Agents) additionally govern occupational safety for work with biological agents.
During a Praxisbegehung (practice inspection) by the Gesundheitsamt or Landeszahnaerztekammer, inspectors verify: a written Hygieneplan (hygiene plan), complete Chargendokumentation (load documentation) with date, time, parameters, and instrument assignment, a daily Bowie-Dick or Helix test before the first load (KRINKO/BfArM 2012), regular biological controls using Geobacillus stearothermophilus, proper waste management per state regulations, staff qualification documentation per DGSV Fortbildungsempfehlung (MPBetreibV Section 5), and maintenance records for all reprocessing equipment.
IfSG Section 73: Administrative offenses under the Infection Protection Act carry fines of up to 25,000 EUR. For serious violations, Sections 74-76 IfSG impose criminal penalties -- particularly when inadequate reprocessing has caused a health risk.
Tattoo, piercing, and permanent makeup: Studios operating without proper registration with the Gesundheitsamt or with serious hygiene deficiencies risk Betriebsschliessung (closure of operations). Refusal to cooperate during a Praxisbegehung is classified as a serious violation. Specific fine ranges vary by Bundesland.
Podiatry: Podiatry practices are subject to the same penalty framework as other healthcare facilities. The supervisory authority may also initiate professional disciplinary proceedings. The Vermutungswirkung (presumption of conformity) under MPBetreibV Section 8(2) -- the presumption that reprocessing is adequate when the KRINKO/BfArM Recommendation is followed -- is lost when documented procedures are violated.
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