IEC 62353 pdf download.MEDICAL ELECTRICAL EQUIPMENT – RECURRENT TEST AND TEST AFTER REPAIR OF MEDICAL ELECTRICAL EQUIPMENT
1 Scope
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 :1 988 (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 1 6 of IEC 60601 -1 :2005 + IEC 60601 -1 :2005/AMD1 :201 2 1 . 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. 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 60364-7-71 0 or national equivalents.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply. NOTE Some of the definitions are necessarily different from those in IEC 60601 -1 , as different measuring methods are used.3.1 ACCESSIBLE CONDUCTIVE PART an electrically conductive part of the ME EQUIPMENT other than an APPLIED PART , which is accessible to the patient or to the operator in contact with the patient or can come in contact with the patient 3.2 ACCESSORY additional part for use with equipment in order to: – achieve the intended use, – adapt it to some special use, – facilitate its use, – enhance its performance, or – enable its functions to be integrated with those of other equipmentt [SOURCE: IEC 60601 -1 :2005, 3.3] 3.3 ACCOMPANYING DOCUMENT document accompanying ME EQUIPMENT , an ME SYSTEM , equipment or an ACCESSORY and containing information for the RESPONSIBLE ORGANIZATION or operator, particularly regarding basic safety and essential performance [SOURCE: IEC 60601 -1 :2005, 3.4] 3.4 APPLIED PART part of ME EQUIPMENT that in normal use necessarily comes into physical contact with the patient for ME EQUIPMENT or an ME SYSTEM to perform its function [SOURCE: IEC 60601 -1 :2005, 3.8, modified – The notes in the original definition have been deleted because they were only internally relevant to the source document.] 3.5 APPLIED PART LEAKAGE CURRENT current flowing between an F – TYPE APPLIED PART and all of the following as applicable: − MAIN PARTS and − ACCESSIBLE CONDUCTIVE PARTS of the enclosure; caused by an external voltage on the F – TYPE APPLIED PART . 3.6 CLASS I term referring to electrical equipment in which protection against electric shock does not rely on basic insulation only, but which includes an additional safety precaution in that means are provided for accessible parts of metal or internal parts of metal to be protectively earthed [SOURCE: IEC 60601 -1 :2005, 3.1 3]
IEC 62353 pdf download
