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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".