AAMI has published eight new/reaffirmed standards in August:
ANSI/AAMI/IEC 60601-2-47:2012, Medical electrical equipment – Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems (Revision of ANSI/AAMI EC38:2007.)
ANSI/AAMI PB70:2012, Liquid barrier performance and classification of protective apparel and drapes in health care facilities
ANSI/AAMI/ISO 11137-2:2012, Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose
ANSI/AAMI/ISO TIR23810:2012, Cardiovascular implants and artificial organs – Checklist for preoperative extracorporeal circulation equipment setup
ANSI/AAMI/ISO 25539-3:2011, Cardiovascular implants – Endovascular devices – Part 3: Vena Cava Filters
ANSI/AAMI/ISO 11140-3:2007/(R)2012, Sterilization of health care products – Chemical indicators – Part 3: Class 2 indicator systems for use in the Bowie and Dick steam penetration test
ANSI/AAMI/ISO 11140-4:2007/(R)2012, Sterilization of health care products – Chemical indicators – Part 4: Class 2 indicators as an alternative to Bowie and Dick test for detection of steam penetration
ANSI/AAMI/ISO 11140-5:2007/(R)2012, Sterilization of health care products – Chemical indicators – Part 5: Class 2 indicators for Bowie and Dick air removal test sheets and packs
