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Related Legislation

ISO 9001

  1. NP ISO 31000:2018: Risk Management. Guidelines
  2. NP EN ISO 13485:2017: Medical devices. Quality management systems. Requirements for regulatory purposes (ISO-13485:2016)
  3. ISO 13485:2016: Medical devices. A Practical Guide (Advice from ISO/TC 210)
  4. NP EN ISO 9001:2015: Quality management system - Requirements (4ª Edition)
  5. NP EN ISO 11137-1:2015: Quality management systems. Fundamentals and vocabulary (3ªEdition)
  6. NP EN ISO 11137-3:2009: Sterilization of health care products. Radiation Part 3: Guidance on dosimetric aspects (ISO 11137-3:2006)
  7. NP EN ISO 9001:2008: Quality management system - Requirements (3ª Edition)
  8. 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)
  9. ISO 11137-1:2006 (Amd.1:2013(E)
  10. NP EN ISO 13485:2003: Medical devices - Quality management systems. Requirements for regulatory purposes
  11. ISO 11137:1995: Sterilization of Health Care Products - Requirements for validation and routine control: radiation sterilization"

Decree-laws

  1. 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
  2. DL n.º222/2008: 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
  3. DL nº215/2008: Amendment to DL n.º 165/2002, 17 de Julho
  4. 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
  5. 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
  6. DL n.º165/2002: Attributes to DGS the competence for licensing public or private entities providing services in the area of radiological protection, dosimetry and training, and issuing radiological passbooks for outside workers
  7. DL n.º337/2002: 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