Scope and object
This clause of the General Standard applies except as follows:
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,
- DIALYSING FLUID CONCENTRATES,
- water purification EQUIPMENT,
- EQUIPMENT used to perform peritoneal dialysis (see IEC 60601- 2-39).
1.3 Particular standards
This particular standard refers to IEC 60601-1 (1988): MEdical electrical equipment - Part 1: General requirements for safety as amended by its amendment 1 (1991) and amendment 2 (1995).
For brevity IEC 60601-1 is referred to in this particular standard either as the General Standard or as the General Requirement(s).
The numbering of sections, clauses and subclauses of this particular standard corresponds to that of the General Standard. The changes to the text of the General Standard are specified by the use of the following words:
Replacement means that the clause or subclause of the General Standard is replaced completely by the text of this particular standard.
Addition means that the clause or subclause of this particular standard is additional to the requirements of the General Standard.
Amendment means that the clause or subclause of the General Standard is amended as indicated by the text of this particular standard.Subclauses or figures which are additional to those of the General Standard are numbered starting from 101, additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.
The term this standard is used to make reference to the General Standard and this particular standard taken together.
Where there is no corresponding section, clause or subclause in this particular standard, the section, clause or subclause of the General Standard although possibly not relevant, applies without modification; where it is intended that any part of the General Standard, although possibly relevant, is not to be applied, a statement to that effect is given in this particular standard.
1.5 Collateral standards
IEC 60601-1-2 applies (see clause 36)