BS EN 60601-2-16:1998
Medical electrical equipment. Particular requirements for safety. Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment

Standard No.

BS EN 60601-2-16:1998

Release Date

1998

Published By

British Standards Institution (BSI)

Status

Be replaced 2015-07

Replace By

BS EN 60601-2-16:2015

Latest

BS EN 60601-2-16:2015

Replace

96/560319 DC-1996 BS 5724 Part 2 Section 2.16:1989

Scope

Addition: This particular standard specifies the minimum safety requirements for single PATIENT HAEMODIALYSIS, HAEMODIAFILTRATION and HAEMOFILTRATION 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 and HAEMOFILTRATION 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).

BS EN 60601-2-16:1998 history

• 2015 BS EN 60601-2-16:2015 Medical electrical equipment. Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
• 1998 BS EN 60601-2-16:1998 Medical electrical equipment. Particular requirements for safety. Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment