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CSA C22.2 NO 60601-2-16

Medical electrical equipment — Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment

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Organization: CSA
Publication Date: 1 January 2019
Status: active
Page Count: 184
ICS Code (Transfusion, infusion and injection equipment): 11.040.20
ICS Code (Syringes, needles and catheters): 11.040.25
scope:

This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HAEMODIALYSIS, HAEMODIAFILTRATION and HAEMOFILTRATION EQUIPMENT, hereafter referred to as HAEMODIALYSIS EQUIPMENT.

This document 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. It does, however, take into consideration the specific safety requirements of such HAEMODIALYSIS EQUIPMENT concerning electrical safety and PATIENT safety.

This document 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.

This document 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.

If applicable, this document applies to the relevant parts of ME EQUIPMENT intended for other extracorporeal blood purification treatments.

The particular requirements in this document do not apply to:

- EXTRACORPOREAL CIRCUITS (see ISO 8637-2, [12]2);

- DIALYSERS (see ISO 8637-1, [11]);

- DIALYSIS FLUID CONCENTRATES (see ISO 23500-4, [18]);

- DIALYSIS WATER supply systems (see ISO 23500-2, [16]);

- CENTRAL DELIVERY SYSTEMS for DIALYSIS FLUID CONCENTRATES (see ISO 23500-4, [18]), described as systems for bulk mixing concentrate at a dialysis facility;

- equipment used to perform PERITONEAL DIALYSIS (see IEC 60601-2-39, [8]).

2 Numbers in square brackets refer to the Bibliography.

An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that there is guidance or rationale related to that item in Annex AA.

Document History

CSA C22.2 NO 60601-2-16
January 1, 2019
Medical electrical equipment — Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HAEMODIALYSIS, HAEMODIAFILTRATION and HAEMOFILTRATION EQUIPMENT, hereafter referred to as HAEMODIALYSIS EQUIPMENT....
Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
A description is not available for this item.
January 1, 2014
Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HAEMODIALYSIS, HAEMODIAFILTRATION and HAEMOFILTRATION EQUIPMENT, hereafter referred to as HAEMODIALYSIS EQUIPMENT....
Medical electrical equipment — Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment
Addition: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HAEMODIALYSIS, HAEMODIAFILTRATION and HAEMOFILTRATION EQUIPMENT, hereafter referred to as HAEMODIALYSIS...
Medical Electrical Equipment - Part 2-16: Particular Requirements for the Safety of Haemodialysis, Haemodiafiltration and Haemofiltration Equipment
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 Electrical Equipment - Part 2-16: Particular Requirements for the Safety of Haemodialysis, Haemodiafiltration and Haemofiltration Equipment
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 Electrical Equipment Part 2: Particular Requirements for the Safety of Haemodialysis Equipment
This clause of the General Standard applies except as follows: This Particular Standard specifies the safety requirements for single PATIENT single pass HAEMODIALYSIS EQUIPMENT as defined in...

References

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