This is the third edition of CAN/CSA-C22.2 No. 60601-2-16, Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment, which is an adoption without modification of the identically titled IEC (International Electrotechnical Commission) Standard 60601-2-16 (third edition, 2008-04). It supersedes the previous edition, published in 2001 as CAN/CSA-C22.2 No. 60601-2-16, Medical electrical equipment - Part 2-16: Particular requirements for the safety of haemodialysis, haemodiafiltration and haemofiltration equipment (adopted IEC 60601-2-16:1998). It is one in a series of Standards issued by CSA under Part II of the Canadian Electrical Code.
201. Scope, object and related standards
Clause 1 of IEC 60601-1:2005 applies, except as follows: 201.
Addition: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ILTRATION and HAEMOFILTRATION EQUIPMENT, hereafter referred to as HAEMODIALYSIS EQUIPMENT.
This International standard does not take into consideration the DIALYSING FLUID control system of HAEMODIALYSIS EQUIPMENT using regeneration of DIALYSING FLUID and CENTRAL DELIVERY SYSTEMS. It does however take into consideration the specific safety requirements of such HAEMODIALYSIS EQUIPMENT concerning electrical safety and PATIENT safety.
This International standard specifies the minimum safety requirements for HAEMODIALYSIS EQUIPMENT. These devices are intended for use either by medical staff or for use by the PATIENT or other trained personnel under the supervision of medical expertise.
This International standard includes all ME EQUIPMENT that is intended to deliver a HAEMODIALYSIS, HAEMODIAFILTRATION and HAEMOFILTRATION treatment to a PATIENT suffering from kidney failure.
The particular requirements in this International standard do not apply to: - EXTRACORPOREAL CIRCUITS; - DIALYSERS; - DIALYSING FLUID CONCENTRATES; - water treatment equipment; - equipment used to perform PERITONEAL DIALYSIS (see IEC 60601-2-39).
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of IEC 60601-1.
NOTE See also 4.2 of IEC 60601-1:2005.
The object of this particular standard is to establish BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for HAEMODIALYSIS EQUIPMENT
201.1.3 Collateral standards Addition: This particular standard refers to those applicable collateral standards that are listed in Clause 2 of IEC 60601-1, and Clause 201.2 of this International Standard. (See also Clauses 202, 203, 206, 208, 209 and 210) IEC 60601-1-3 does not apply.