SS IEC 60601-2-16:2018
Medical electrical equipment – Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
OVERVIEW
Applies to the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment, hereafter referred to as haemodialysis equipment.
Does not take into consideration specific safety details of the dialysis fluid control system of haemodialysis equipment using regeneration of dialysis fluid or central delivery systems for dialysis fluid. Does, however, take into consideration the specific safety requirements of such haemodialysis equipment concerning electrical safety and patient safety.
Specifies the minimum safety requirements for haemodialysis equipment. these haemodialysis equipment are intended for use either by medical staff or for use by the patient or other trained personnel under medical supervision.
Includes all ME equipment that is intended to deliver a haemodialysis, haemodiafiltration and haemofiltration treatment to a patient, independent of the treatment duration and location.
COMMENTS
-
PRODUCT DETAILS
| Status | Current |
|---|---|
| Edition | 2018 |
| No. of Pages | 79 |
| ICS Classification | 11.040.20 Transfusion, infusion and injection equipment 11.040.25 Syringes, needles and catheters |
| Committee | Biomedical and Health Standards Committee |
| Available for Purchase | Global |
| Adoption | IEC 60601-2-16 : 2018 IDT |