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

• The Quality System Compendium: GMP Requirements & Industry
  Practice, 2ed
  

FDA DOCUMENTS

• Quality System Regulation (21 CFR Parts 808, 812, and 820)
• Medical Device Quality Systems Manual: A Small Entity Compliance Guide, 1st Edition
• Design Control Guidance for Medical Device Manufacturers
• FDA's Guide to Inspections of Quality Systems (QSIT)

REFERENCE COLLECTIONS (ON CD)

• Quality Systems Collection
• The Importance of Effective Medical Device Reporting CD
• Medical Equipment Symbols and Safety Signs - Clip Art Collection
  

KEY STANDARDS AND GUIDANCE DOCUMENTS

• ANSI/AAMI/ISO 13485:2003 - 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 - 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 - 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 - 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 HE48:1993 - Human factors engineering guidelines and preferred practices for the design of medical devices, 2ed
• ANSI/AAMI HE74:2001 - Human factors design process for medical devices, 1ed
• ANSI/AAMI/IEC 60601-1-2:2007 - Medical electrical equipment, Part 1-2: General requirements for safety—Collateral standard: Electromagnetic compatibility — Requirements and tests
• ANSI/AAMI/ISO 15223:2007 - Medical devices—Symbols to be used with medical device labels, labeling, and information to be supplied- Part 1. General requirements
• ANSI/AAMI/ISO 15225:2000 - Nomenclature—Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange, 1ed
• AAMI TIR18:1997 - Guidance on electromagnetic compatibility of medical devices for clinical/biomedical engineers—Part 1: Radiated radio-frequency electromagnetic energy, 1ed
• AAMI TIR24:1999 - Acquisition and use of physiologic waveform databases for testing of medical devices, 1ed
• AAMI TIR32:2004-Medical device software risk management
• ANSI/AAMI/IEC TIR60878:2003 - Graphical symbols for electrical equipment in medical practice, 1ed
• ANSI/AAMI/IEC TIR62296:2003 - Considerations of unaddressed safety aspects in the Second Edition of IEC 60601-1 and proposals for new requirements, 1ed
• ANSI/AAMI/ISO TIR16142:2005 - Medical devices—Guidance on the selection of standards in support of recognized essential principles for safety and performance of medical devices