IEC 62353:2014 pdf free download – Medical electrical equipment – Recurrent test and test after repair of medicalelectrical equipment
1 Scope
This International Standard applies to testing of MEDICAL ELECTRICAL EQUIPMENT and MEDICALELECTRICAL SYSTEMs, hereafter ‘referred to as ME EQUIPMENT and ME SYSTEMS, or parts of suchequipment or systems，which comply with IEC 60601-1:1988(second edition) and itsamendments and lEC 60601-1: 2005 (third edition) and its amendments, before PUTTING INTOSERVICE，during MAINTENANCE，INSPECTION，SERVICING and after REPAIR or on occasion ofRECURRENT TESTs to assess the safety of such ME EQUIPMENT or ME SYSTEMS or parts thereof.For equipment not built to lEC 60601-1 these requirements may be used taking into accountthe safety standards for the design and information in the instructions for use of thatequipment.
This standard contains tables with allowable values relating to different editions ofIEC 60601-1.For the purpose of this standard,the application of measuring methods isindependent of the edition according to which the ME EQUIPMENT or ME sYSTEM is designed.
This standard contains:
– “general requirements”, which contain clauses of general concern,and
– “particular requirements”，further clauses handling special types of ME EQUIPMENT or ME sYSTEMs and applying in connection with the “General requirements”.
NOTE At this stage, there are no particular requirements.
This standard is not suitable to assess whether ME EQUIPMENT or ME SYSTEMs or any otherequipment comply with the relevant standards for their design.
This standard is not applicable to the assembly of ME sYSTEMS.For assembling ME SYSTEMSsee Clause 16 of lEC 60601-1:2005+ IEC 60601-1:2005/AMD1:20121.
This standard does not define requirements for REPAIR,exchange of components andMODIFICATION of ME EQUIPMENT or ME SYSTEMS.
AlMAINTENANCEINSPECTION,SERVICING,and REPAIR done in accordance withMANUFACTURER’s instructions maintain the conformity to the standard used for the design ofthe equipment.Otherwise conformity to applicable requirements should be assessed andverified, before the tests of this standard are performed.
This standard is also applicable to tests after REPAIR.
IEC 60601-1:2005 + IEC 60601-1:2005/AMD1:2012 requires that, as part of the RISKMANAGEMENT PROCEss，the MANUFACTURER considers how the safety of ME EQUIPMENT or anME SYSTEM can be ensured during product lifetime.As part of the risk management processthe MANUFACTURER may have identified MAINTENANCE procedures. This includes defining therespective tests for ME EQUIPMENT or for ME SYSTEM.
Competent personnel shall perform these tests. Competence shall include training on thesubject，knowledge,experience and acquaintance with the relevant technologies，designstandards and local regulations. The personnel assessing the safety shall be able torecognize possible consequences and risks arising from non-conforming equipment.
Each individual equipment of an ME SYSTEM which can be connected/disconnected fromSuPPLY MAiINs without the use of a tool, shall be tested individually.Additionally the ME SYSTEMas a whole shall be tested to avoid a situation where aging of individual equipment can resultin unacceptable values (see Annex H).
An ME SYSTEM that is connected with a MULTIPLE SOCKET-OUTLET to suPPLY MAINS shall betreated during the tests like a single item of equipment.
lf 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 orother means,e.g. by electrically conducting mountings or cooling water pipes, the testing ofPROTECTIVE EARTH RESISTANCE shall be performed on every single equipment.
When equipment combined into an ME sYSTEM by FUNCTIONAL CONNECTION,cannot be testedseparately 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 orthe results of the measurements, shall be included in the tests.AcCESsORIES included in thetests shall be documented.
DETACHABLE POWER SUPPLY CORDs that are available and expected to be used withME EQUIPMENT or ME SYSTEM , shall be inspected and the PROTECTIVE EARTH RESISTANCE shallbe measured according to 5.3.2.