BS EN 60601-2-9:1997

This standard BS EN 60601-2-9:1997 Medical electrical equipment. Particular requirements for safety is classified in these ICS categories:

• 11.040.50 Radiographic equipment
• 17.240 Radiation measurements

This clause of the General Standard applies except as follows:

1.1 Scope

Addition:

This Particular Standard specifies the particular requirements for the safety of dosemeters used in medical practice in the patient environment for radiotherapy as defined in 2.104.

NOTE dosemeters not intended for use in the patient environment are not covered by this Standard and should meet the requirements of IEC 1010-1.

The requirements of this Standard for electrical safety, robustness and disinfectability apply to dosemeters with any type of electrically connected radiation detector intended for use in physical contact (not electrical contact) with a patient.

The requirements for performance in IEC 731 apply only to dosemeters with ionization chambers as radiation detectors.

The dose monitoring systems incorporated in radiotherapy equipment are not covered by this Particular Standard.

1.3 Particular Standards

Addition:

This Particular Standard is to be read in conjunction with IEC 601-1 (1988): Medical electrical equipment — Part 1: General requirement for safety, with 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".

A requirement of this Particular Standard replacing or modifying a requirement of the General Standard takes precedence over the corresponding 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 text 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

Replacement:

This Standard is to be read in conjunction with the Collateral Standards IEC 601-1-1 and IEC 601-1-2. No other Collateral Standards apply.