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Portuguese Version

Related Legislation

ISO Standards

1. IAF-ISO/2024: Joint Communiqué on the addition of Climate Change considerations to Management Systems Standards.
2. NP ISO 31000:2018: Risk Management. Guidelines.
3. NP EN ISO 13485:2017: Medical devices. Quality management systems. Requirements for regulatory purposes (ISO-13485:2016).
4. ISO 13485:2016: Medical devices. A Practical Guide (Advice from ISO/TC 210).
5. NP EN ISO 9001:2015: Quality management system - Requirements (4ª Edition).
6. NP EN ISO 11137-1:2015: Quality management systems. Fundamentals and vocabulary (3ªEdition).
7. NP EN ISO 11137-3:2009: Sterilization of health care products. Radiation Part 3: Guidance on dosimetric aspects (ISO 11137-3:2006).
8. NP EN ISO 9001:2008: Quality management system - Requirements (3ª Edition)
9. ISO 11137-1:2006: Sterilization of health care products - Radiation. Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (1ª edition 2006-04-15).
10. ISO 11137-1:2006 (Amd.1:2013(E).
11. ISO 11137:1995: Sterilization of Health Care Products - Requirements for validation and routine control: radiation sterilization".

Decree-laws

1. Decreto-Lei nº29/2024: It ensures the implementation, in the domestic legal order, of Regulation (EU) 2017/745 on medical devices.
2. Rectification Nº1-B/2024: Rectifies Law Nº356/2023 on the Regulation of Legal Metrological Control of Radiation Measurement Instruments.
3. DL nº139-D/2023: Changes the legal regime of radiological protection.
4. Law nº359/2023: Approves the Regulation on the Legal Metrological Control of Pressure Gauges, Vacuum Gauges and Manocumeters.
5. Portaria nº356/2023: Approves the Regulation on the Legal Metrological Control of Ionizing Radiation Measuring Instruments.
6. DL nº145/2009: Establishes the rules governing the research, manufacture, marketing, commissioning, surveillance and advertising of medical devices and their accessories and transposes into national law Directive 2007/47/EC of the European Parliament and of the Council of 5 September.
7. DL nº108/2018: Council Directive 2013/59 / Euratom, of 5 December 2013, sets the basic safety standards for protection against the dangers arising from exposure to ionizing radiation. Transfers DGS assignments to the APA.
8. DL nº222/2008: Treaty establishing EURATOM. It provides for the establishment of basic safety standards for the protection of health, workers and the population in general, against the dangers arising from ionizing radiation
9. DL nº215/2008: Amendment to DL n.º 165/2002, 17 de Julho
10. DL nº038/2007: Council Directive 2003/122 / EURATOM, of 22 December, on the control of sealed radioactive sources, including sources of high activity and orphan sources, to the internal legal order and establishes the protection regime people and the environment against the risks associated with loss of control, loss, accident or disposal resulting from inadequate regulatory control of radioactive sources
11. DL nº167/2002: It establishes the basic safety principles and norms for the health protection of the population and workers against the dangers arising from ionizing radiation, as well as the fundamental measures related to the radiation protection of people undergoing medical examinations and treatments, have been the object of Community legislative harmonization, which has been properly transposed into the domestic legal system
12. DL nº337/2002: Transposes Directive 1999/2/EC, of the European Parliament and of the Council, of 22 February, on the approximation of the laws of the Member States relating to foods and food ingredients treated with ionizing radiation, into national law. Directive No. 1999/3/EC, of the European Parliament and of the Council, of 22 February, on the establishment of a Community list of foods and food ingredients treated with ionizing radiation