Every dental practice in Portugal must have a written reprocessing protocol, in line with Portaria n.º 99/2024/1, accessible in the reprocessing area and approved by the clinical director. ERS may request it during inspections under form mod-133_02; IGAS may carry out unannounced inspections. Dental practices have until 14 March 2029 to adapt to the new technical requirements. This guide describes what the protocol must contain, how it should be structured, and how always-accessible digital documentation responds directly to inspection requirements — a local PC failure is not a defense.
In Portugal, every dental practice must have a written reprocessing protocol, accessible to all staff and available for presentation during inspections. This document describes the procedure to follow at each step of the reprocessing chain and assigns responsibilities. Portaria n.º 99/2024/1, of 13 March, sets the current technical framework; the ERS dental-clinic inspection form (mod-133_02) explicitly verifies the existence of the written reprocessing protocol, accessible in the reprocessing area. The protocol must be approved by the clinical director.
The designation of the person responsible for reprocessing within the practice. A detailed description of each step in the reprocessing chain (decontamination, washing, rinsing, drying, packaging, autoclaving, storage), with the zone separation introduced by Portaria 99/2024/1. The maintenance and validation schedule for the autoclave (initial qualification, annual operational qualification under NP EN ISO 17665-1, preventive maintenance). The frequency of biological and physico-chemical controls (Bowie-Dick / Helix daily, NP EN ISO 11140-1 chemical indicators, NP EN ISO 11138 biological indicators). The traceability method used (paper or digital register). Clinical waste management procedures. The continuing education plan for staff.
For a step-by-step breakdown of the reprocessing chain, see our dental sterilization chain guide.
A cycle is valid when the recorded parameters match the selected program and all indicators are compliant. In Portuguese dental practice, the reference cycle is 134°C with appropriate holding time (the prion cycle is recommended for instruments in contact with nervous or lymphoid tissue). The autoclave must be Class B to sterilize hollow instruments (turbines, contra-angles) and wrapped loads, in accordance with NP EN 13060.
Before the first load of each working day, a Bowie-Dick test (pre-vacuum autoclaves) or Helix test (hollow instruments) validates proper autoclave function. 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.
ERS (Entidade Reguladora da Saúde) operates the licensing portal for private healthcare establishments and holds sanctioning powers — administrative fines may reach €44,891.81. IGAS (Inspeção-Geral das Atividades em Saúde) carries out inspections, including unannounced ones. The ERS dental-clinic inspection form (mod-133_02) verifies: the existence of the written reprocessing protocol; the automatic or mechanical recording of cycles (date, time, cycle number, phases); the separation of decontamination and sterilization zones; the OMD registration of the clinical director with an active Cédula Profissional; and maintenance and training records.
The OMD (Ordem dos Médicos Dentistas, established by Lei n.º 110/91), together with IGAS, participates in coordinated inspections. Mandatory OMD registration means the OMD can receive and process complaints regarding clinical-practice deficiencies, including sterilization. Dental practices have until 14 March 2029 to adapt to the new technical requirements of Portaria 99/2024/1.
The protocol must define the traceability method used. Portuguese regulations do 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.
A digital register eliminates these risks. SecuSteri automatically imports the autoclave report, links each instrument to its cycle, and generates a validated, tamper-proof record. Each cycle is archived according to the plan's retention period, accessible at any time during an ERS or IGAS inspection. A local PC failure is not a defense — cloud accessibility is the structural answer.
For a detailed comparison, see our digital vs paper register guide.
Verify every compliance point before the inspector arrives. Download the PDF instantly — no email required.