A Radiological Protection Commission (CPR) of Brazilian College of Radiology and Diagnostic Imaging (CBR) It provides free access to legislation and recommendations.
National Legislation on Diagnostic Imaging
RDC No. 611 and ANVISA Normative Instructions for Diagnostic and Interventional Radiology Services
On December 26, 2019, the National Health Surveillance Agency (ANVISA) published Collegiate Board Resolution (RDC) No. 330 in the Official Gazette of the Union (DOU). This regulation revoked Ordinance SVS/MS No. 453/1998 and Resolution RE No. 1016/2006, establishing new requirements for radiology services.
Subsequently, on March 16, 2022, Resolution RDC No. 611/2022 was published in the Official Gazette (Section 1, No. 51), updating and consolidating the sanitary requirements for the organization and operation of diagnostic and interventional radiology services. This resolution regulates the control of medical, occupational, and public exposures resulting from the use of radiological technologies.
Resolution RDC No. 611/2022 is part of ANVISA's 2021–2023 Regulatory Agenda (Project 1.2), aligned with Decree No. 10,139/2019, which establishes guidelines for the consolidation and simplification of regulations, without promoting substantive changes. Thus, RDC No. 611/2022 consolidates and revokes RDCs No. 330/2019 and No. 440/2020.
Complementing RDC No. 611, Normative Instructions (IN) No. 90 to No. 97, of May 27, 2021, were published, detailing the requirements for quality and safety assurance in the following modalities:
- ● Conventional Medical X-ray;
- ● Fluoroscopy and Interventional Radiology;
- ● Mammography;
- ● Computed Tomography;
- ● Dental Radiology (Extraoral and Intraoral);
- ● Ultrasound;
- ● Magnetic Resonance Imaging (MRI).
- The normative instructions also define the minimum acceptance and quality control tests, their frequencies, tolerances, and restriction criteria applicable to health services.
Access the full text of Resolution RDC No. 611/2022 and the Normative Instructions at the links below.
Resolution RDC No. 611, of March 9, 2022
Resolution RDC No. 611/2022 is part of ANVISA's 2021–2023 Regulatory Agenda (Project 1.2), aligned with Decree No. 10,139/2019, which establishes guidelines for the consolidation and simplification of regulations, without promoting substantive changes. Thus, RDC No. 611/2022 consolidates and revokes RDCs No. 330/2019 and No. 440/2020.
Normative Instructions - IN
Normative Instruction – IN No. 90/2021
This law establishes sanitary requirements to ensure quality and safety in conventional medical radiography systems, and provides other related measures.
Normative Instruction – IN No. 91/2021
This law establishes sanitary requirements to guarantee the quality and safety of fluoroscopy and interventional radiology systems, and provides other measures.
Normative Instruction – IN No. 92/2021
This law establishes sanitary requirements to guarantee the quality and safety of mammography systems, and provides other related measures.
Normative Instruction – IN No. 93/2021
This law establishes sanitary requirements to ensure quality and safety in medical computed tomography systems, and provides other measures.
Normative Instruction – IN No. 94/2021
This law establishes sanitary requirements to guarantee quality and safety in extraoral dental radiology systems, and provides other related measures.
Normative Instruction – IN No. 95/2021
This law establishes sanitary requirements to ensure quality and safety in intraoral dental radiology systems, and provides other related measures.
Normative Instruction – IN No. 96/2021
This document establishes sanitary requirements to guarantee quality and safety in diagnostic or interventional ultrasound systems, and provides other related measures.
Normative Instruction – IN No. 97/2021
This law establishes sanitary requirements to ensure quality and safety in nuclear magnetic resonance imaging systems, and provides other related measures.
Normative Instruction SGP/SEGGG/ME No. 15, of March 16, 2022 - MPOG
Establishes guidelines on the granting of additional payments for unhealthy working conditions, hazardous work, ionizing radiation, and bonuses for work with X-rays or radioactive substances, and provides other measures applicable to public servants.
CNEN Standard NN 3.01 - Basic requirements for radiation protection and radiological safety of radiation sources, dated April 18, 2024 - CNEN
It establishes the general principles and basic requirements for radiation protection of people and the environment, and for the radiological safety of ionizing radiation sources.
CNEN Standard NN 3.05 - Safety and radiological protection requirements for nuclear medicine services, dated December 17, 2013 - CNEN
It establishes the safety and radiation protection requirements for in vivo Nuclear Medicine Services.
Regulatory Standard No. 6 (NR-6) - Personal Protective Equipment (PPE), dated January 16, 2025 - MTE
The purpose of this NR (Regulatory Standard) is to establish the requirements for the approval, marketing, supply, and use of Personal Protective Equipment – PPE.
Regulatory Standard No. 7 (NR-7) - Occupational Health Medical Control Program (PCMSO), dated March 10, 2022 - MTE
This NR (Regulatory Standard) establishes guidelines and requirements for the development of the Occupational Health Medical Control Program – PCMSO in organizations, with the objective of protecting and preserving the health of their employees in relation to occupational risks, according to the risk assessment of the organization's Risk Management Program – PGR.
Regulatory Standard No. 15 (NR-15) - Unhealthy Activities and Operations, dated October 7, 2022 - MTE
This NR (Regulatory Standard) establishes the activities that should be considered unhealthy, generating the right to an additional payment for unhealthy work conditions for workers. It consists of a general part and maintains 13 annexes, which define the Tolerance Limits for physical, chemical, and biological agents, when it is possible to quantify the contamination of the environment, or listing or mentioning situations in which the work is considered qualitatively unhealthy.
NR-15 / Annex 5 - Ionizing Radiation, dated December 18, 2018 - MTE
Amends Annex No. 5 – Ionizing Radiation – of Regulatory Standard No. 15 (NR-15) – Unhealthy Activities and Operations
Regulatory Standard No. 16 (NR-16) - Hazardous Activities and Operations, dated August 28, 2024 - MTE
The standard is composed of a general part, containing definitions and procedures for payment of the hazard pay supplement, and annexes that deal specifically with hazardous activities. Regarding the topic of Ionizing Radiation, the corresponding annex/table (no number) was initially established by Ministry of Labor Ordinance No. 3,393, of December 17, 1987, and revoked by Ministry of Labor and Employment Ordinance No. 496, of December 11, 2002, having been subsequently reinstated by Ministry of Labor and Employment Ordinance No. 518, of April 4, 2003. On this topic, the CTPP discussed a question regarding "Mobile X-rays," which led to the insertion of an "explanatory note" to this annex/table, published by Ministry of Labor and Employment Ordinance No. 595, of May 7, 2015.
Regulatory Standard No. 32 (NR-32) - Occupational safety and health in health services, dated December 22, 2022 - MTE
This Regulatory Standard – NR aims to establish the basic guidelines for implementing measures to protect the safety and health of workers in health services, as well as those who carry out activities to promote and assist health in general.
Resolution RDC No. 50, of February 21, 2002 - ANVISA
This document establishes the Technical Regulation for the planning, programming, development, and evaluation of physical projects for healthcare facilities.
International Regulations and Recommendations
Radiation Protection and Safety of Radiation Sources: International Basic Safety Standards. General Safety Requirements Part 3 - No. GSR Part 3, 2014 Jointly sponsored by EC, FAO, IAEA, ILO, OECD/NEA, PAHO, UNEP, WHO
This publication is the new edition of the International Basic Safety Standards. The edition is co-sponsored by seven other international organizations—the European Commission (EC/Euratom), FAO, the International Labour Organization (ILO), OECD/NEA, PAHO, UNEP, and WHO. It has been extensively revised and updated to take into account the latest findings of the United Nations Scientific Committee on the Effects of Atomic Radiation and the most recent recommendations of the International Commission on Radiological Protection. The publication details the requirements for protecting people and the environment from the harmful effects of ionizing radiation and for the safety of radiation sources. All circumstances of radiation exposure are considered.
IAEA Safety Standards Series No. GSG-7 - General Safety Guide
This Safety Guide, prepared jointly by the International Atomic Energy Agency (IAEA) and the International Labour Organization (ILO), provides guidance on meeting the requirements of the International Basic Safety Standards (IAEA Safety Standards Series No. GSR Part 3) with respect to occupational exposure. It provides general guidance on developing occupational radiation protection programs, as appropriate for the radiation sources likely to be encountered in the workplaces in question, to fulfill management's responsibility for protection and safety. Detailed guidance is also provided on monitoring and evaluating worker exposure due to external radiation sources and the ingestion of radionuclides. The Safety Guide reflects internationally accepted principles and recommended best practices in occupational radiation protection, taking into account conceptual changes and technological advancements that have occurred in the last decade.
IAEA Safety Standards Series No. RS-G-1.5 - Specific Safety Guide
This Safety Guide, co-sponsored by PAHO and WHO, provides recommendations on how safety requirements can be met for the protection of patients, caregivers, and patient visitors from exposure to ionizing radiation in medical practice, in accordance with Appendix II (Medical Exposure) of the Safety Series No. 115, International Basic Safety Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources (1996). The recommendations cover the establishment of reference levels for diagnostic medical exposures, acceptance testing processes for radiation equipment, calibration of radiotherapy units, and notification of accidental medical exposures.
ICRP Publication 135 - Diagnostic Reference Levels in Medical Imaging
The International Commission on Radiological Protection (ICRP) first introduced the term "diagnostic reference level" (DRL) in 1996 in Publication 73. The concept was subsequently developed and practical guidance was provided in 2001. The DRL has proven to be an effective tool that helps optimize protection in medical patient exposure for diagnostic and interventional procedures. This publication provides a comprehensive methodology for establishing DRLs at the local, national, and regional levels for different modalities of diagnostic imaging radiation application.
Global Initiative on Radiation Safety in Health Care Settings - WHO
The WHO is conducting a Global Initiative on Radiological Safety in Healthcare Settings to mobilize the healthcare sector towards the safe and effective use of radiation in medicine. By integrating radiation protection with the concepts of good medical practice and quality of healthcare services, this initiative provides a platform for collaboration between health authorities, radiation protection regulatory bodies, international agencies, professional societies, patient networks, scientific bodies, academic institutions and other stakeholders, aiming to improve the implementation of radiation safety standards in healthcare settings.
Other ICRP publications
ICRP is:
● An independent international organization that promotes, for the public benefit, the science of radiation protection, in particular by providing recommendations and guidance on all aspects of protection against ionizing radiation;
- ● A non-profit organization, registered with the Charities Commission of England and Wales (registration number 1166304);
- ● A non-profit organization, registered with the Charities Commission of England and Wales (registration number 1166304);
- ● A community of approximately 350 globally recognized experts in the science, policy, and practice of radiation protection, from about 40 countries.
- The ICRP's collection of publications can be found at:
7) Radiation Protection of Patients (RPOP) - IAEA: Health Professionals
Healthcare professionals can learn about the safe use of ionizing radiation in medicine. This section answers frequently asked questions about different medical procedures and provides links to other resources, such as notification and learning systems.
Radiation Protection Recommendations
ABFM-CBR-SOBRICE - Radiation Protection in Interventional Radiology
Learn about the document issued by ABFM-CBR-SOBRICE on Protection in Interventional Radiology.
IAEA and WHO - Radiation Protection in Interventional Radiology
Discover 10 actions to improve radiation protection in medicine over the next decade.
IAEA - 10 recommendations for patient protection in fluoroscopy
Here are 10 recommendations for protecting patients during fluoroscopy:
IAEA - 10 recommendations for staff protection in fluoroscopy
Here are 10 recommendations for protecting staff during fluoroscopy:
Image Gently Care for children with heart conditions.
Discover Image Gently's recommendations for the care of children with heart conditions who require special attention.
Image Gently - US guideline for radiopharmaceutical activities administered to children and adolescents
Follow the US guideline for Pediatric Nuclear Medicine For high-quality images with low radiation doses.
Image Gently CT scans in children
Learn about the recommendations and guidelines for CT scans in children:
Image Gently Good practice - Appropriate selection of imaging exams for children and adolescents.
Learn about the hierarchy in appropriate choice of imaging exams For children and teenagers.
Image Gently Pause and Pulse
meet the Stop and Pulse – Document of Image Gently about fluoroscopic procedures that help save children's lives.