BS EN 62353-2008 pdf download.Medical electrical equipment Recurrent test and test after repair of medical electrical equipment.
Each individual equipment of an ME SYSTEM which has its own connection to SUPPLY MAINS, or 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.
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 has to 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.
If items of ME EQUIPMENT, which are combined into an ME SYSTEM by FUNCTIONAL CONNECTION, cannot be tested separately for technical reasons, 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.
All DETACHABLE POWER SUPPLY CORDS, which are available ready for use, 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 hazards arise for testing personnel. patients or other individuals.
If not otherwise stated, all values for current and voltage are the r.m.s. values of an alternating, direct or composite voltage or current,
4.2 Testing before PUTTING INTO SERVICE, after MODIFICATIONS, and after REPAIR
Before first time operation as intended:
— of new or modified ME EQUIPMENT or ME SYSTEMS,
— of ME EQUIPMENT or ME SYSTEMS not yet tested according to Clause 5, or
— of REPAIRED ME EQUIPMENT or ME SYSTEMS.
the applicable tests as listed in Clause 5 shall be performed.
4.3 * RECURRENT TEST
The applicable tests as listed in Clause 5 shall be used for 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 2 or the tables in Annex E.
If the measured values are between 90 % and 100 % of the acceptable limit, previously measured values (REFERENCE VALUE) shall be taken into consideration for the assessment of the ELECTRICAL SAFETY of the ME EQUIPMENT or the ME SYSTEM. If such previous data values are not available, reduced intervals between upcoming RECURRENT TESTS shall be taken into account.
ME SYSTEMS shall be visually inspected to determine whether the configuration is still the same as at the time of the last INSPECTION, or whether units of the Mc SYSTEM have been exchanged, added or removed. Such changes shall be documented, as well as any changing of the configuration of ME SYSTEM, and will void the validity of previous REFERENCE VALUES. Measurement results/values measured after changes of the ME SYSTEM shall be documented as REFERENCE VALUES.
5 * Tests
5.1 General
Prior to testing. consult the ACCOMPANYING DOCUMENTS 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 and atmospheric pressure as present at the site of testing. Requirements for supply voltage as defined in IEC 60601-1 do not have to be fulfilled.
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 required in this standard, or
— if there is an indication of inadequate safety.BS EN 62353-2008 pdf download.