1. ScopeAddition:
This Particular Standard specifies safety requirements for OPERATING TABLES, as defined in 2.12.101, whether or not having electrical parts, including TRANSPORTERS, as defined in 2.12.104, used for the transportation of the table top to or from the base or pedestal of an OPERATING TABLE with detachable table top.
This Particular Standard does not apply to
- dental patient chairs
- examination chairs and couches
- patient supporting systems of diagnostic and therapeutic devices
- operating table heating blankets
- patient transfer equipment
- delivery tables and beds
- hospital beds
- field tables.
1.3 Particular Standards
Addition:
This Particular Standard refers to IEC 60601-1 (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 Particular Standard either as the General Standard or as the General Requirements(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 text of this Particular Standard is additional to the requirements of the General Standard.
Amendement 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.
The requirements of this Particular Standard take priority over those of the General Standard.
An asterisk() beside a clause or subclause number indicates that some explanatory notes are given in the General guidance and rationale section at the end of this Particular Standard.