IEC TR 60930 pdf download Guidelines for administrative, medical, and nursing staff concerned with the safe use of medical electrical equipment and medical electrical systems
This technical report is intended to lessen the RISK to PATIENTS , OPERATORS , and their surroundings by providing a code of safe application. This reduction of RISK is in addition to that brought about by the RISK CONTROL measures incorporated in the MEDICAL ELECTRICAL 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 IEC standards. From time to time, OPERATORS and RESPONSIBLE ORGANIZATIONS will encounter 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 the home healthcare environment provided the MANUFACTURER has included home use in the INTENDED USE or the CLINICAL ENGINEERING DEPARTMENT has checked that the electrical installation and the physical environment will not result in any unacceptable RISKS .
These guidelines can also be applied to equipment used for compensation or alleviation of disease, injury or disability. If the ME EQUIPMENT , an ME SYSTEM or the installation does not comply with the relevant IEC standards, the RESPONSIBLE ORGANIZATION should consult with the CLINICAL ENGINEERING DEPARTMENT or the MANUFACTURER for instructions on how to achieve an adequate level of safety.
2 Normative 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 edition of the referenced document (including any amendments) applies.
IEC 60601 -1 :2005, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
IEC 60601 -1 -2:2007, Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests
IEC 60601 -1 -8:2006, Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
IEC 62353:2007, Medical electrical equipment – Recurrent test and test after repair of medical electrical 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.