AAMI Standards

AAMI is a premiere source for medical device standards and technical documents. Five of AAMI's standards are particularly relevant to Quality Systems. Links to these documents are provided below:

• ANSI/AAMI/ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes
• ANSI/AAMI/ISO TIR 14969:2004 Medical devices-Quality management systems-Guidance for the application of ISO 13485:2003
• ANSI/AAMI/ISO 14971:2007 Medical devices-Application of risk management to medical devices
• ANSI/AAMI/IEC 62304:2006 Medical device software-Software life cycle processes
• AAMI TIR32:2004 Medical Device Software Risk Management

Other Standards

ISO and IEC have standards that have not been adopted by AAMI, but are still relevant for Quality Systems professionals. Links to these websites are provided below:

• ISO 9000:2005 Quality management systems - Fundamentals and vocabulary
• ISO 19011:2002 Guidelines for quality and/or environmental management systems auditing
• ISO 9001:2000 Quality management systems - Requirements
  This standard is being revised. Please visit www.asq.org for more information on this document's status.
• IEC 62366:2007 Medical devices - Application of usability engineering to medical devices
  This document is in draft form, but should be published in 2007. Please visit www.iec.ch for more information on this document's status