Medical Device Use, Safety, and Quality Addressed in AAMI Standards
The AAMI standards include recommended practices, and guidance documents for healthcare facilities and the medical device industry. Examples of topics covered in the AAMI standards are
- Biological evaluation
- Handling and biological decontamination
- Labels
- Quality management
- Packaging
- Process control
- Specific devices including: BIER/EO gas vessels, cardiovascular implants, blood pressure transducers, cardiac defibrillator devices, electrocardiographic devices, electrosurgical devices, hemodialysis systems, infant incubators, medical electrical equipment, nerve stimulators, pacemakers, sphygmomanometers
- Sterilization
- Validation and routine control
AAMI standards are developed and used by biomedical and clinical engineers; consultants; materials/purchasing/supply specialists; technology managers; physicians; nurses; quality assurance professionals; regulatory affairs managers; and representatives from manufacturing corporations, hospitals, FDA, and others who place patient safety and quality healthcare as the highest priority.
Online Access - Subscribers to AAMI standards online get secure online access to search, view, bookmark, track, and print documents according to the AAMI license agreement. Online AAMI standards documents are updated daily. Multiple users can share a single license. You also get access to IHS Standards bibliographic data – more than 1 Million documents.
Individual Documents - Individual AAMI standards are available through the IHS Store in downloadable electronic (PDF) or hard copy formats. Statistics show that 1 out of every 5 people who purchase individual documents would benefit from an online subscription. If your company buys more than $3,000 in AAMI standards per year, you should consider a collection over individual document purchases.
AAMI Standards Documents List
AAMI Standards Collection - Description