AAMI/IEC 60601-2-16:2012

Specifies the minimum safety requirements for single-patient haemodialysis, haemodiafiltration and haemofiltration equipment. These devices are intended for use either by medical staff or under the supervision of medical expertise, including haemodialysis, haemodiafiltration and haemofiltration equipment operated by the patient.. The addenda addresses comments received during the process of harmonizing the standard in Europe; alphabetical sorting of the definitions section; improves the reference to 60601-1-8, including reference to 60606-1-11; adds an appendix with a hazardous situation list; updates several references to defined terms that were not printed in SMALL CAPS; and improves terminology usage.