Quality System Publications
AAMI is a worldwide leader in the effort to enhance the safe and effective use of medical instrumentation and technologies. Through standards development and the publication of books, standards, recommended practices, technical information reports, periodicals, and a host of electronic resources, AAMI is the #1 source for medical device standards and guidance documents.
Quality System
Reference Collections (on CD)
Key Standards and Guidance Documents
- ANSI/AAMI/ISO 13485:2003/(R)2009 - Medical devices — Quality management systems — System requirements for regulatory purposes, 2ed
- ANSI/AAMI/ISO TIR 14969:2004 - Quality systems — Medical devices — Guidance on the application of ISO 13485;2003
- ANSI/AAMI/ISO
14971:2007/(R)2010 - Medical devices — Application
of risk management to medical devices
Additional Standards and Guidance Documents
- ANSI/AAMI/ISO 11135-1:2007 - Sterilization of health care products — Ethylene oxide - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
- ANSI/AAMI/ISO 11137-1:2006/(R)2010 - Sterilization of health care products — Radiation - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices
- ANSI/AAMI/ISO 11137-2:2006 - Sterilization of health care products — Radiation - Part 2: Establishing the sterilization dose
- ANSI/AAMI/ISO 11137-3:2006/(R)2010 - Sterilization of health care products — Radiation - Part 3: Guidance on dosimetric aspects
- ANSI/AAMI/IEC 62304:2006 - Medical device software — Software life cycle processes, 2ed
- AAMI TIR32:2004 - Medical device software risk management
- AAMI TIR36:2007 - Validation of software for regulated processes
- ANSI/AAMI/IEC 62366: 2007 - Medical devices — Application of usability engineering to medical devices
- ANSI/AAMI HE75:2009 - Human factors engineering — Design of medical devices
- ANSI/AAMI/IEC 0601-1-2:2007 - Medical electrical equipment, Part 1-2: General requirements for safety — Collateral standard: Electromagnetic compatibility — Requirements and tests
- ANSI/AAMI/ISO 15223-1:2007 - Medical devices — Symbols to be used with medical device labels, labeling, and information to be supplied-Part 1. General requirements
- ANSI/AAMI/ISO 15223-2:2010 - Medical devices — Symbols to be used with medical device labels, labeling and information to be supplied - Part 2: Symbol development, selection and validation
- ANSI/AAMI/ISO 15225:2010 - Nomenclature—Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange, 1ed
- AAMI TIR18:2010 - Guidance on electromagnetic compatibility in healthcare facilities
- AAMI TIR24:1999 - Acquisition and use of physiologic waveform databases for testing of medical devices, 1ed
- AAMI/ANSI/IEC TIR80002-1:2009 - Medical device software — Part 1. Guidance on the application of ISO 14971 to medical device software
- ANSI/AAMI/IEC TIR60878:2003 - Graphical symbols for electrical equipment in medical practice, 1ed
- ANSI/AAMI/IEC TIR62296:2009 - Considerations of unaddressed safety aspects in the Second Edition of IEC 60601-1 and proposals for new requirements
- ANSI/AAMI/ISO TIR16142:2005 - Medical devices — Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices