IEC 61882:2016 Published

On March 3, 2016, a new edition became available. IEC 61882:2016 Hazard and Operability Studies (HAZOP Studies) – Application Guide provides information on HAZOP studies using guide words. The new version includes definitions, preparation, examination sessions, documentation and follow-up. According to the IEC website the new edition includes significant technical changes including:

  • Clarification of terminology
  • Alignment with terms and definitions within ISO 31000:2009 and ISO Guide 73:2009
  • An improved case study of a procedural HAZOP

HAZOP is one of the supporting tools cited in Annex G of ISO 14971:2007 Medical Devices – Application of Risk Management to Medical Devices