Scope
This clause of the General Standard applies except as follows:
1.1 Scope
Addition:
This Standard Specification specifies requirements for FLUID WARMERS as defined in 2.2.101.
1.2 Object
Addition:
The object of this Standard Specification is to establish requirements for FLUID WARMERS which minimize hazards to PATIENT and OPERATOR and to specify tests by which compliance can be verified.
1.3 Particular Standards
Addition:
This Standard Specification refers to IEC 601-1 (1988): Medical electrical equipment - Part 1: General requirements for safety, as amended by its amendments 1(1991) and 2 (1995).
For brevity Part 1 is referred to in this Standard Specification either as the General Standard or as the General requirement(s).
The numbering of sections, clauses and sub-clauses of this Standard Specification 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 sub-clause of the General Standard is replaced completely by the text of this Standard Specification.
"Addition" means that the text of this Standard Specification is additional to the requirements of the General Standard.
"Amendment" means that the clause or sub-clause of the General Standard is amended as indicated by the text of this Standard Specification.
Sub-clauses 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 a reference to the General Standard and this Standard Specification taken together.
Where there is no corresponding section, clause or sub-clause in this Standard Specification, the section, clause or sub-clause 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 Standard Specification.
1.101 Equipment excluded
This Standard Specification does not apply to:
- Non-inline fluid warmers, e.g. warming cabinets, fresh frozen plasma/frozen red cell thawing devices, electric bowl heaters
- Extracorporeal / open-heart bypass warming circuits
- Fluid warmers integral to dialysis units
