EN 60601-2-57-2011 pdf download.Medical electrical equipment -Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic,diagnostic, monitoring and cosmetic/aesthetic use.
201 .8.11.101 CoolIng liquid
Where liquid is used in IS EQUIPMENT for cooling and where the liquid assumes the task of BASIC INSULATION to the SUPPLY MAINS, the conductivity of the liquid shall be such that the leakage current values required in 8.7 of the general standard are not exceeded In NORMAL USE. The conductivity of the liquid shall be continuously monitored by the LS EQUIPMENT. In case of leakage current exceeding the values required in 8.7 of the general standard as a result of increased liquid conductivity, the LS EQUIPMENT shall be switched off automahcally from the SUPPLY MAINS.
Compliance is checked by inspection and functional tests.
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS Clause 9 of the general standard applies.
201.10 Protection against unwanted and excessive radiation HAZARDS
Clause 10 of the general standard applies except as follows:
Additional subclauses:
201.10.101 Disabling device
IS EQUIPMENT may be fitted with a suitable device that disables the release of OPTICAL RADIATION in the absence of the target tissue.
If the IS EQUIPMENT is classified into a lower risk group by implementing such a device, the following requirement shall be met. Once an exposure has been completed, the equipment shall not be capable of emitting OPTICAL RADIATION again until the device has been reactivated.
201.10.102 Shield
Where the applicator is used in contact with the target area, LS EQUIPMENT of Risk Group 3
shall incorporate a means which prevents radiation being emitted from the applicator in a
direction other than intended for the treatment.
IS EQUIPMENT may additionally incorporate a removable or fixed means which prevents USER exposure to radiation scattered from the target area.
The spatial variation of the LS EQUIPMENT OUTPUT over the treatment area shall not deviate from the average irradiance or radiant exposure by more than ± 20% when the LS EQUIPMENT is Risk Group 3. A decrease of output greater than 20% is acceptable for the edge of the treatment area (20 % of the area).
Compliance testing: the detector area of the measuring device should not be larger than the typical absorption depth of the wavelengths incident on the target tissue. For visible and IR LS EQUIPMENT a detector area corresponding to 2 mm detector diameter may be chosen.
201.10.104 Controls and Indicators
For the protection of the PATIENT, the OPERATOR, and other persons present, LS EQUIPMENT of Risk Group 3 shall incorporate:
a) Key-operated master control. The key shall be removable and the OPTICAL RADIATION shall not be accessible when the key is removed.
NOTE In this particular standard the term key includes any other control devices, such as magnetic cards.
cipher corn binations. computer passwords. etc.
b) Visible or audible READY INDICATOR, which shall be illuminated or audible when emission of the OPTICAL RADIATION is possible upon actuation of the control switch, to allow appropriate safety precautions to be taken.
c) OPTICAL RADIATION indicator
In addition to the READY INDICATOR, LS EQUIPMENT shall be equipped with a visible or an audible signal, which clearly indicates that emission of OPTICAL RADIATION S taking place.
If the indicators are of visible type, the READY INDICATOR and the OPTICAL RADIATION indicator shall be visible through protective eyewear recommended by the MANUFACTURER.
d) STAND-BY/READY control
LS EQUIPMENT shall be equipped with a STAND-BY/READY control. On initial switch-on the IS EQUIPMENT shall default to STAND-BY condition.
Compliance is checked by inspection.
201.10.105 Exposure termination
When the exposure termination is by means of a timer, for IS EQUIPMENT classified as Risk Group 3. protection against SINGLE FAULT CONDITIONS shall be provided by a safety device which is independent of the timer and is activated when the set time is exceeded by 20 %. The safety device shall terminate the OPTICAL RADIATION output and shall prevent further operation of the equipment.EN 60601-2-57-2011 pdf download.