CSA - CAN/CSA-C22.2 NO. 60601-2-16-01
Medical Electrical Equipment - Part 2-16: Particular Requirements for the Safety of Haemodialysis, Haemodiafiltration and Haemofiltration Equipment
| Organization: | CSA |
| Publication Date: | 1 June 2001 |
| Status: | inactive |
| Page Count: | 33 |
| ICS Code (Transfusion, infusion and injection equipment): | 11.040.20 |
| ICS Code (Medical equipment): | 11.040 |
scope:
This particular standard specifies the minimum safety requirements for single PATIENT HAEMODIALYSIS, HAEMODIAFILTRATION EQUIPMENT (as defined in 2.101). These devices are intended for use either by medical staff or under the supervision of medical expertise, including HAEMODIALYSIS, HAEMODIAFILTRATION EQUIPMENT operated by the PATIENT. These particular requirements do not apply to
- EXTRACORPOREAL CIRCUITS,
- DIALYSERS,
- DIALYSING FLUID CONCENTRATES,
- water purification EQUIPMENT,
- EQUIPMENT used to perform peritoneal dialysis (see IEC 60601- 2-39).
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