IEC 60601-2-16 applies to the essential safety and essential performance of hemodialysis, hemodiafiltration and hemofiltration equipment. IEC 60601-2-16 does not consider the dialysis fluid control system and central distribution systems of Hemodialysis equipment using dialysis fluid regeneration. However, it does take into account the specific safety requirements of such hemodialysis equipment regarding electrical safety and patient safety.
IEC 60601-2-16 specifies minimum safety requirements for hemodialysis equipment. These devices are intended for use by either medical personnel or other trained personnel under the supervision of the patient or medical professional. IEC 60601-2-16 includes all electromedical equipment intended to provide hemodialysis.
This edition includes the following important technical changes from the previous edition:
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