CEI EN 62353 PDF

This International Standard applies to testing of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS, or parts of such equipment or systems, which comply with IEC 60601-1:1988 (second edition) and its amendments and IEC 60601-1:2005 (third edition) and its amendments, before PUTTING INTO SERVICE, during MAINTENANCE, INSPECTION, SERVICING and after REPAIR or on occasion of RECURRENT TESTS to assess the safety of such ME EQUIPMENT or ME SYSTEMS or parts thereof. For equipment not built to IEC 60601-1 these requirements may be used taking into account the safety standards for the design and information in the instructions for use of that equipment.

This standard contains tables with allowable values relating to different editions of IEC 60601-1. For the purpose of this standard, the application of measuring methods is independent 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 other equipment comply with the relevant standards for their design.

This standard is not applicable to the assembly of ME SYSTEMS. For assembling ME SYSTEMS see Clause 16 of IEC 60601-1:2005 + IEC 60601-1:2005/AMD1:2012¹.

This standard does not define requirements for REPAIR, exchange of components and MODIFICATION of ME EQUIPMENT or ME SYSTEMS.

All MAINTENANCE, INSPECTION, SERVICING, and REPAIR done in accordance with MANUFACTURER's instructions maintain the conformity to the standard used for the design of the equipment. Otherwise conformity to applicable requirements should be assessed and verified, 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 RISK MANAGEMENT PROCESS, the MANUFACTURER considers how the safety of ME EQUIPMENT or an ME SYSTEM can be ensured during product lifetime. As part of the risk management process the MANUFACTURER may have identified MAINTENANCE procedures. This includes defining the respective tests for ME EQUIPMENT or for ME SYSTEM.

The MANUFACTURER may have defined necessary measurement settings and methods including performance assurance tests in the instructions for use or other ACCOMPANYING DOCUMENTS. This standard provides consistent test procedures.

This standard is not intended to define time intervals for RECURRENT TESTS. If such intervals are not defined by the MANUFACTURER, Annex F can be used to help establish such intervals.

Testing of the electrical installation, including the SUPPLY MAINS and associated wiring, in medical locations is excluded from this standard. Such tests are covered by IEC 60364-7-710 or national equivalents,

¹ This citation refers to IEC 60601-1:2005 as amended by Amendment 1 published in 2012.