The national members of ISO and IEC have approved for publication the third edition of ISO/IEC Guide 63, Guide to the development and inclusion of aspects of safety in International Standards for medical devices. A joint project of ISO/TC 210 and IEC/SC 62A, Guide 63 provides standards writers in the healthcare technology sector with practical guidance on how to include safety aspects when developing standards for the sector. This includes management system standards related to medical devices.
Based on risk management principles and ISO/IEC Guide 51:2014, Guide 63 is intended to address the particular needs of the healthcare technology sector. The requirements and recommendations in the third edition are based on well-established risk management concepts and methodology. The guide is intended to assist standards writers to include safety aspects in a way that will facilitate use of their documents within a risk-based framework.
The concept of safety, as described in Guide 63, is closely related to protecting the patients who are the subjects of medical care, as well as those persons who are giving the care and other potentially affected persons. Safety is also related to harm to property or the environment.
The third edition has been restructured to follow the organization of ISO/IEC Guide 51:2014. The defined terms have been updated and many are derived from ISO/IEC Guide 51:2014. The definitions of manufacturer and medical device have been revised based on the GHTF guidance documents GHTF/SG1/N055:2009 and GHTF/SG1/N071:2012. New guidance on the use of the terms “safety”, “safe”, “effective” and “effectiveness” has also been added to this edition.