BS EN ISO 9680:1996 download free.Dental operating light.
1 Scope
BS EN ISO 9680 applies to dental operating lights, however constructed, used for illuminating the oral cavity. Its specifies requirements and test methods. It also contains specifications on manufacturer’s instructions, marking and packaging.
2 Normative references
The following standards contain provisions which, through reference in this text, constitute provisions of BS EN ISO 9680. At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on BS EN ISO 9680 are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below. Members of IEC and ISO maintain registers of currently valid International Standards. ISO 1942-4:1989, Dental vocabulary — Part 4. Dental equipment.
ISO 9687:1993, Dental equipment — Graphical symbols.
IEC 598-1:1986, Luminaires — Part 1: General requirements and tests.
IEC 601-1:1988, Medical elect rica! equipment — Part 1: General requirements for safety.
CIE 15.2:1986. Colorimetry.
CIE 69:1987, Methods of characterizing ilium inance meters and lu m incince meters; Performance, characteristics and specifications.
3 Definitions
For the purposes of BS EN ISO 9680, the definitions given in ISO 1942-4 and the following definitions apply.
3.1
luminaire
apparatus which distributes, filters or transforms the light transmitted from one or more lamps and which includes all parts necessary for supporting, fixing and protecting the lamps, but not the lamps themselves, and where necessary circuit auxiliaries together with the means of connecting them to the supply [IEC 598.1:1986]
3.2
lamp
light source
3.3
dental luminaire
luminaire specially designed and/or presented for use in the dental surgery
3.4
dental operating light
item of equipment specially designed for use by a dentist for illuminating the oral cavity, consisting of a dental luminaire and one or more lamps
4 Classification
4.1 According to type of protection against electric shock
Dental operating lights are classified as follows:
a) Class I equipment
Equipment in which protection against electric shock does not rely on basic insulation only, but which includes an additional safety precaution in such a way that means are provided for the connection of accessible conductive parts to the protective (earth) conductor in the fixed wiring of the installation in such a way that accessible conductive parts cannot become live in the event of a failure of the basic insulation.
b) Class II equipment
Equipment in which protection against electric shock does not rely on basic insulation only, but in which additional safety precautions such as double insulation or reinforced insulation are provided, there being no provision for protective earthing or reliance upon installation conditions.
4.2 According to degree of protection against electric shock
Dental operating lights are only of type B equipment.
Type B equipment
Class I or II equipment, or equipment with an internal electrical power source providing an adequate degree of protection against electric shock particularly regarding:
— allowable leakage currents:
— reliability of the protective earth connection (if present).
Type B equipment is, for example, suitable for intentional external and internal application to the patient, excluding direct cardiac application.
4.3 According to mode of operation Dental operating lights are a type of equipment with continuous operation.
4.4 Marking or identification
The classification shall be marked or identified in accordance with 8.2.
5 Requirements and recommendations
5.1 General
Dental operating lights shall be designed, constructed and manufactured so that, when properly transported. stored, installed, used and maintained according to the manufacturer’s instructions, they cause no danger which could reasonably be foreseen to the patient, to the personnel or to the surroundings in normal use and in single-fault condition.
The dental operating light shall have the strength and rigidity necessary to resist the stresses to which it may be subjected in normal dental practice without risk of introducing fire, electric shock or accident hazard.
Those dental operating lights which are intended to be permanently fixed on the ceiling, the wall or the floor shall have provision for this (see 5.3.4.3). Testing shall be carried out in accordance with 7.2. If the equipment also passes all the tests described in this International Standard, it shall be considered that these requirements are fulfilled. In addition, it is recommended that edges and corners of components and parts accessible to the patient or personnel should be finished in such a manner as to avoid injury to the patient or personnel.
5.2 Optical
5.2.1 Level of illuminance
The level of illurninance shall be adjustable. The adjustment should preferably be continuous but, if in steps, it shall be made with at least three levels of illuminance (two approximately equal steps). The adjustment of illumination shall include a range from 80001x to 15 000 lx.
Testing shall be carried out in accordance with 7.2 and 7.3.2.
5.2.2 Illumination pattern
The area of maximum illuminance shall lie within a circle of 50 mm diameter with no illuminance less than 75% of the maximum. If the illuminance pattern is larger than the 50 mm diameter circular area, the 50 % of maximum illuminance isolux should be plotted (see Figure 1).
Testing shall be carried out in accordance with 7.3.2.
5.2.3 Illumination uniformity
The illumination shall decrease in intensity progressively and smoothly (with reversal of slope not exceeding 10 % of the centre illumination) toward the pattern edge, within the limits given in 5.2.2.
Testing shall be carried out in accordance with 7.3.2.
5.2.4 Illumination in patient’s eyes
The level of illumination 60 mm above a line parallel to a horizontal line through the area of maximum illuminance shall be not greater than 1 200 lx (see Figure 1).
Testing shall be carried out in accordance with 7.3.2.
5.2.5 Light points in reflector
The reflector should be free of glare in the patient’s eyes during normal operation.
Testing shall be carried out in accordance with 7.2.