BS EN 60601-2-9:1997

Introduction
Section One - General
1 Scope and object
2 Terminology and definitions
5 Classification
6 Identification, marking and documents
Section Two - Environmental Conditions
Section Three - Protection against Electric Shock Hazards
15 Limitation of voltage and/or energy
Section Four - Protection against Mechanical Hazards
21 Mechanical Strength
Section Five - Protection agains Hazards from Unwanted or
Excessive Radiation
Section Six - Protection against Hazards of Ignition of
Flammable Anaesthetic Mixtures
Section Seven - Protection against Excessive Temperatures and
Other Safety Hazards
44 Overflow, spillage, leakage, humidity, ingress of liquids,
    sterilization and disinfection
Section Eight - Accuracy of Operating Data and Protection
Against Hazardous Output
50 Accuracy of operating data
Section Nine - Abnormal Operation and Fault Conditions;
Environmental Tests
Section Ten - Constructional Requirements
Appendix L References - Publications mentioned in this
             Standard
Annex AA Index of defined terms
Annex ZA (normative) Normative references to international
             publications with their corresponding
             European publications
Annex ZB (informative) Normative references to
             international publications with their
             corresponding European publications

Defines particular requirements for safety of dosemeters for use in medical practice in the patient environment for radiotherapy.

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 IEC1010-1. 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 IEC731 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 IEC601-1(1988): Medical electrical equipment— Part1: General requirement for safety, with amendments 1 (1991) and 2 (1995). For brevity Part1 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 IEC601-1-1 and IEC601-1-2. No other Collateral Standards apply.