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 |
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)
Document History