IEC 60601-2-50 pdf download.Medical electrical equipment
1 Scope and object
This clause of the General Standard applies except as follows: 1.1 Scope Addition: This Particular Standard specifies requirements applicable to INFANT PHOTOTHERAPY EQUIPMENT (as defined in 2.1.101) which by means of visible radiation serve to reduce bilirubin in the body of infants suffering from icterus in the first months of life. 1.2 Object Replacement: The object of this Particular Standard is to establish requirements for INFANT PHOTOTHERAPY EQUIPMENT which reduce the safety hazards to PATIENTS and operators as much as possible and to specify tests for demonstrating compliance with these requirements. 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 amendment 1 (1991) and its amendment 2 (1995). For brevity, IEC 60601-1 is referred to in this Particular Standard either as the General Standard or as the 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 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 1: General requirements for safety – 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 safety – 4. Collateral standard: Programmable electrical medical systems
4 General requirements for tests
This clause of the General Standard applies, except as follows: 4.6 Other conditions Additions: *4.6.101 Pre-ageing The following general operating conditions shall be taken into account for radiation measurements of therapeutical PHOTOTHERAPY EQUIPMENT for the human body. After 5 h of pre-ageing of the radiator source, or after operating the pre-ageing time specified by the manufacturer, if the manufacturer has specified a different pre-ageing time in the ACCOMPANYING DOCUMENTS , the initial values of the PHOTOTHERAPY EQUIPMENT shall be measured at normal load without exceeding the given tolerances for the temperature rise. 4.6.102 Position of burning The measurements shall be taken in the operating position of the lamp of the PHOTOTHERAPY EQUIPMENT..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.