IEC 60601-2-50:2000 pdf download
IEC 60601-2-50:2000 pdf download.Medical electrical equipment – Part 2-50:Particular requirements for the safety of infant phototherapy equipment.
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 ihis 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
Addition:
IEC 60601-1-1:1992, Medical electrical equipment — Part 1: General requirements for safety —
1. Collateral standard: Safety requirements for medical electrical systems
IEC 60601-1-2:1993, Medical electrical equipment — Part 1: General requirements for safety — 2. Collateral standard: Electromagnetic compatibility — Requirements and tests
IEC 60601-1-3:1994, Medical electrical equipment — Part I: General requirements safely — 3 Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment
IEC 60601-1-4:1996 Medical electrical equipment — Part 1: General requirements for safely — 4. Collateral standard: Programmable electrical medical systems
2 Terminology and definitions
This clause of the General Standard applies, except as follows:
2.1 EQUIPMENT parts, auxiliaries and ACCESSORIES
Additional definitions:
2.1.101
INFANT PHOTOTHERAPY EQUIPMENT (hereinafter referred to as PHOTOTHERAPY EQUIPMENT)
irradiation equipment which emits in the main radiation spectrum in the range between 400 nm and 550 nm for reducing the concentration of bilirubin in the body of infants
2.1.102
EFFECTIVE SURFACE AREA
surface on which the PATIENT rests according to the intended position and which is radiated by the PHOTOTHERAPY EQUIPMENT
4.6.103 Burn-in period
The PHOTOTHERAPY EQUIPMENT shall be operated until all parameters which are important for the measurement have reached stable conditions. Therefore, it is necessary to wait for the state of thermal equilibrium. The burn-in period shall be at least 0,5 h, or longer, unless the manufacturer states a different time in the ACCOMPANYING DOCUMENTS
*4.6.104 Arrangement in space
The PHOTOTHERAPY EQUIPMENT shall be orientated such that the centre of THE EFFECTIVE SURFACE AREA and the radiant output area are parallel and the centres are in the same line and at the distance(s) specified by the manufacturer.
5 Classification
This clause of the General Standard applies, except as follows:
Addition:
5.3.101 If PHOTOTHERAPY EQUIPMENT is located under the PATIENT it shall at least comply with
IPX4 specified in IEC 60529.
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
Addition:
*6.1.101 A symbol for requiring eye shields for the PATIENT shall be used if the PATIENT’S eyes can be exposed to the PHOTOTHERAPY EQUIPMENT’S radiation. See Figure 101.
6.2 Marking on the inside of EQUIPMENT or EQUIPMENT parts
6.2. b)
Addition:
The types of lamps specified or recommended by the manufacturer shall be indicated.
6.8 ACCOMPANYING DOCUMENTS
This clause of the General Standard applies, except as follows:
6.8.2 Instructions for use
Additions:
*aa) The mean TOTAL IRRADIANCE FOR BILIRUBIN between all points Ebi mm and Ebm max measured on the EFFECTIVE SURFACE AREA and its dependance on the distance between
the PHOTOTHERAPY EQUIPMENT and the EFFECTIVE SURFACE AREA shall be indicated.
If necessary, a notice shall give information about the filter and the protective barrier required for normal use.
The instructions for use shall
— inform the OPERATOR about the necessity of temperature measurements on the PATIENT, if the PHOTOTHERAPY EQUIPMENT will influence the body temperature of the PATIENT;
— contain information about the distance between the PHOTOTHERAPY EQUIPMENT and the EFFECTIVE SURFACE AREA. If the distance between the PHOTOTHERAPY EQUIPMENT and the EFFECTIVE SURFACE AREA is adjustable, the manufacturer has to describe how the operator can keep to the permissible distances;
— inform the OPERATOR about the impact of PHOTOTHERAPY EQUIPMENT on the heat supply in thermotherapy devices (incubators, radiant heaters, heated mattresses) and on the PATIENT’S body temperature;
— inform the OPERATOR that the use of the skin-controlled mode of the incubator, an infant radiant warmer or heated mattresses is recommended, otherwise the set air temperature of the incubator or the heater output of the radiant warmer or heated mattress has to be reduced according to body temperature measurements.
