IEC TR 60930:2008 pdf free download Guidelines for administrative, medical, and nursing staff concerned with the safe use of medical electrical equipment and medical electrical systems
1Scope
This technical report is intended to lessen the RISK to PATIENTS,OPERATORS, and theirsurroundings by providing a code of safe application.This reduction of RISK is in addition tothat brought about by the RISK CONTROL measures incorporated in the MEDICALELECTRICAL EQUIPMENT, the MEDICAL ELECTRICAL SYSTEM, and the electrical installation in medical locations,hereafter referred to as ME EQUIPMENT,ME SYSTEM and installation respectively.
Not all existing ME EQUIPMENT,ME SYSTEMS or installations meet the requirements of the relevant lEC standards. From time to time, OPERATORS and RESPONSIBLE ORGANIZATIONS willencounter ME EQUIPMENT and ME SYSTEMS complying with older safety standards. However,the guidelines for safe application given in this technical report should nevertheless be followed in so far as this is possible.
The guidelines in this technical report can be used with ME EQUIPMENT or ME SYSTEMS for thehome healthcare environment provided the MANUFACTURER has included home use in theINTENDED USE or the CLINICAL ENGINEERING DEPARTMENT has checked that the electricalinstallation and the physical environment will not result in any unacceptable RISKs.Theseguidelines can also be applied to equipment used for compensation or alleviation of disease,injury or disability.
lf the ME EQUIPMENT, an ME SYSTEM or the installation does not comply with the relevant lECstandards, the RESPONSIBLE ORGANIZATION should consult with the CLINIGAL ENGINEERINGDEPARTMENT or the MANUFACTURER for instructions on how to achieve an adequate level ofsafety.
2Normative references
The following referenced documents are indispensable for the application of this document.For dated references, only the edition cited applies. For undated references, the latest editionof the referenced document (including any amendments) applies.
IEC 60601-1:2005,Medical electrical equipment – Part 1: General requirements for basicsafety and essential performance
IEC 60601-1-2:2007,Medical electrical equipment- Part 1-2:General requirements for basicsafety and essential performance-Collateral standard: Electromagnetic compatibility – Requirements and tests
IEC 60601-1-8:2006,Medical electrical equipment – Part 1-8:General requirements for basicsafety and essential performance- Collateral Standard:General requirements, tests andguidance for alarm systems in medical electrical equipment and medical electrical systems
IEC 62353:2007, Medical electrical equipment- Recurrent test and test after repair of medicalelectrical equipment
3 Terms and definitions
For the purposes of this document, the terms and definitions in IEC 60601 -1 :2005, IEC 60601 -1 -2:2007, IEC 60601 -1 -8:2006 and IEC 62353:2007 and the following term and definition apply.
NOTE 1 The term “electrical equipment ” is used to mean ME EQUIPMENT or other electrical equipment. This technical report also uses the term “equipment ” to mean ME EQUIPMENT or other electrical or non-electrical equipment in the context of an ME SYSTEM .
NOTE 2 An index of defined terms used in this technical report is found beginning on page 27.
IEC TR 60930:2008 pdf free download
