BS EN 62353-2014 pdf download.Medical electrical equipment Recurrent test and test after repair of medical electrical equipment.
Competent personnel shall perform these tests. Competence shall include training on the subject, knowledge, experience and acquaintance with the relevant technologies, design standards and local regulations. The personnel assessing the safety shall be able to recognize possible consequences and risks arising from non-conforming equipment.
Each individual equipment of an ME SYSTEM which can be connected/disconnected from SUPPLY MAINS without the use of a tool, shall be tested individually. Additionally the ME SYSTEM as a whole shall be tested to avoid a situation where aging of individual equipment can result in unacceptable values (see Annex H).
An ME SYSTEM that Is connected with a MULTIPLE SOCKET-OUTLET to SUPPLY MAINS shall be treated during the tests like a single item of equipment.
If the ME SYSTEM, or a part of it, is connected to SUPPLY MAINS via a separating transformer, the transformer shall be included in the measurements.
In ME SYSTEMS, where more than one ME EQUIPMENT are interconnected by data cables or other means, e.g. by electrically conducting mountings or cooling water pipes, the testing of PROTECTIVE EARTH RESISTANCE shall be performed on every single equipment.
When equipment combined into an ME SYSTEM by FUNCTIONAL CONNECTION, cannot be tested separately for technical reasons, then the complete ME SYSTEM shall be tested.
ACCESSORIES of the ME EQUIPMENT, which can affect the safety of the equipment under test or the results of the measurements, shall be included in the tests. ACCESSORIES included in the tests shall be documented.
DETACHABLE POWER SUPPLY CORDS that are available and expected to be used with ME EQUIPMENT or ME SYSTEM , shall be inspected and the PROTECTIVE EARTH RESISTANCE shall be measured according to 5.3.2.
All tests shall be performed in such manner that no hazardous situations arise for testing personnel, patients or other individuals.
If not otherwise stated, all currents are the r.m.s. values.
4.2 Testing before PUTTING INTO SERVICE, after MODIFICATIONS, and after REPAIR The test methods of this standard can be used:
— by the MANUFACTURER for final testing, and
— for testing before PUTTING INTO SERVICE.
4.3 * RECURRENT TEST
The applicable tests as listed in Clause 5 shall be used for the RECURRENT TEST.
The values found in these tests shall be documented together with the measuring method and shall be assessed. The values measured shall not exceed the acceptable limit as defined in Table 3 or the tables in Annex E.
NOTE Previously measured values (REFERENCE VALUES) can be taken into consideration when assessing the ELECTRICAL SAFETY or the ME EQUIPMENT or the ME SYSTEM.
ME SYSTEMS shall be visually inspected to determine whether the ME SYSTEM CONFIGURATION is still the same as at the time of the last INSPECTION, or whether any equipment making up the ME SYSTEM has been exchanged, added or removed.
Such changes shall be documented, as well as any changes to the hardware CONFIGURATION of the ME SYSTEM, and will void the validity of previous REFERENCE VALUES. Measurement results/values of leakage currents measured after changes of the ME SYSTEM shall be documented as REFERENCE VALUES,
5 * Tests
5.1 General
Prior to testing, the ACCOMPANYING DOCUMENTS shall be consulted to identify the MANUFACTURER’S MAINTENANCE recommendations including any special conditions and precautions that shall be taken into account.
NOTE The recommended sequence of the tests to be performed is defined in Figure 8.1
The tests may be performed at the ambient temperature, humidity, atmospheric pressure and MAINS VOLTAGE as present at the site of testing.
5.2 Visual INSPECTION
Covers and housings shall be opened only:
— if required in the ACCOMPANYING DOCUMENT of the ME EQUIPMENT or ME SYSTEM: or
— if there is an indication of inadequate safety.
Special attention shall be paid to the following:
— safety related marking, labels and labeling are legible and complete:BS EN 62353-2014 pdf download.