IEC 60601-2-43:2000 pdf download

IEC 60601-2-43:2000 pdf download.Medical electrical equipment – Part 2-43:Particular requirements for the safety of X-ray equipment for interventional procedures.
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 the “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 requirements of the General Standard takes precedence over the original requirements concerned.
2 Terminology and definitions
This clause of the General Standard applies, except as follows:
Addition before 2.1:
An index of defined terms used in this standard is given in annex AA.
In this standard, terms printed in small capitals are used in accordance with their definitions in the General Standard, in this standard, in IEC 60788 or in other IEC standards referenced in annex AA.
NOTE Attention is drawn to the fact that where some terms, although listed in annex AA, are not printed in small capitals, the concept addressed is not strictly confined to the formal definition.
In this standard, unless otherwise indicated:
— the values of X-RAY TUBE VOLTAGE refer to peak values, transients being disregarded;
— the values of X-RAY TUBE CURRENT refer to average values;
— qualifying conditions for certain defined terms, as listed in 2.202.1 to 2.202.5 of IEC 60601-1-3, apply.
2.101
RADIOSCOPICALLY GUIDED INVASIVE PROCEDURE
invasive procedure (involving the introduction of a device, such as a needle or a catheter into the body of the PATIENT) using RADIOSCOPIC imaging as the principal means of guidance
2.102
RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURE
RADIOSCOPICALLY GUIDED INVASIVE PROCEDURE indented to effect treatment on the medical
condition of the PATIENT
2.103
INTERVENTIONAL X-RAY EQUIPMENT
X-RAY EQUIPMENT for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES
2.104
INTERVENTIONAL REFERENCE POINT
for INTERVENTIONAL X-RAY EQUIPMENT, specified point on the REFERENCE AXIS used as a reference location for the indication of PATIENT-incident AIR KERMA and AIR KERMA RATE
2.105
DOSE AREA PRODUCT
product of the area of the cross-section of an X-RAY BEAM and the averaged AIR KERMA over that cross-section. The unit is the Gray square metre (Gym2).
— DOSE AREA PRODUCT RATE, with the unit Gym2s—1
— DOSE AREA PRODUCT (RATE), used for brevity where either DOSE AREA PRODUCT or DOSE AREA PRODUCT RATE apply, according to the context.
NOTE The SI unit Gym2 may be expressed with a prefix e.g. as j.tGym2 to retain earlier used numeric dimensions of values displayed to the OPERATOR.
2.106
REFERENCE AIR KERMA
AIR KERMA of the primary X-RAY BEAM measured under specific conditions and expressed as an
equivalent value at the INTERVENTIONAL REFERENCE POINT
— REFERENCE AIR KERMA RATE, AIR KERMA RATE expressed as above
— REFERENCE AIR KERMA (RATE), used for brevity where either REFERENCE AIR KERMA or REFERENCE AIR KERMA RATE apply, according to the context.
2.107
MODE OF OPERATION
for INTERVENTIONAL X-RAY EQUIPMENT, the technical state defined by a configuration of several predetermined LOADING FACTORS, technique factors or other settings for RADIOSCOPY or RADIOGRAPHY, selectable simultaneously by the operation of a single control
NOTE 1 Selection of a particular mode does not necessarily define the values of all the parameters affecting its use. NOTE 2 Values defined by selection of a particular mode are not necessarily invariable during its use.
6 Identification, marking and documents
This clause of the General Standard applies, except as follows:
6.1 Marking on the outside of EQUIPMENT or EQUIPMENT parts
Additional items:
aa) PATIENT SUPPORT load.