Scope and object
This clause of the General Standard applies except as follows:
1.1
Scope
Addition:
This Particular Standard contains requirements for the safety of X-RAY EQUIPMENT designed for mammography and MAMMOGRAPHIC STEREOTACTIC DEVICES.
1.2
Object
Replacement:
The object of this standard is to formulate appropriate design and manufacturing requirements for the safety of mammographic X-RAY EQUIPMENT and MAMMOGRAPHIC STEREOTACTIC DEVICES, reflecting the particular characteristics and circumstances of use of such equipment.
1.3
Particular Standards
Addition:
This Particular Standard, hereinafter referred to as this Standard, amends and supplements a set of IEC publications, hereinafter referred to as General Standard, consisting of IEC 60601-1:1988, Medical electrical equipment - Part 1: General requirements for safety, its amendments 1 (1991) and 2 (1995) and all Collateral Standards. The numbering of sections, clauses and subclauses of this 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 standard.
Addition means that the text of this 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 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.
Where there is no corresponding section, clause or subclause in this standard, the section, clause or subclause of the General Standard 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.
A requirement of this standard replacing or modifying requiremetns of the General Standard takes precedence over the original requirements concerned.
1.3.101
Related International Standards
IEC 60601-2-28: 1993, Medical electrical equipment - Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis
IEC 60601-2-32: 1994, Medical electrical equipment - Part 2: Particular requirements for the safety of associated equipment of X-ray equipment
IEC 60788: 1984, Medical radiology - Terminology
