IEC 60601-1-4:2000 pdf download-Medical electrical equipment – Part 1-1: General requirements for safety – Collateral standard: Safety requirements for medical electrical systems.
6 Identification, marking and documents *6.8.201 A CCOMPANYING DOCUMENTS of a SYSTEM A SYSTEM (including a modified SYSTEM ) shall be accompanied by documents containing all the data necessary for safe and intended use. These documents shall include: a) the ACCOMPANYING DOCUMENTS for each item of MEDICAL ELECTRICAL EQUIPMENT (see 6.8 of IEC 60601 -1 ); b) the equivalent documents for each item of non-medical electrical equipment; c) the following information: – instructions for cleaning and, where applicable, sterilizing and disinfecting each item of equipment forming part of the SYSTEM ; – additional safety measures which should be applied, during installation of the SYSTEM ; – which parts of the SYSTEM are suitable for use within the PATIENT ENVIRONMENT ; – additional measures which should be applied during preventive maintenance; – a warning that MULTIPLE PORTABLE SOCKET – OUTLETS shall not be placed on the floor; – a warning that an additional MULTIPLE PORTABLE SOCKET – OUTLET or extension cord shall not be connected to the system; – a warning not to connect items which are not specified as part of the SYSTEM ; – the maximum permitted load for any MULTIPLE PORTABLE SOCKET – OUTLET ( S ) used with the SYSTEM ; – an instruction that MULTIPLE PORTABLE SOCKET – OUTLETS provided with the SYSTEM shall only be used for supplying power to equipment which is intended to form part of the SYSTEM ; – an explanation of the risks of connecting a non-medical electrical equipment, which has been supplied as a part of the SYSTEM , directly to the wall outlet when the non- medical equipment is intended to be supplied via a MULTIPLE PORTABLE SOCKET – OUTLET with a separating transformer;
1 9 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS *1 9.201 L EAKAGE CURRENTS 1 9.201 .1 E NCLOSURE LEAKAGE CURRENT In NORMAL CONDITION , the ENCLOSURE LEAKAGE CURRENT from or between parts of the SYSTEM within the PATIENT ENVIRONMENT shall not exceed 0,1 mA. NOTE For the purpose of this standard, the LEAKAGE CURRENT from accessible outer surfaces of equipment is also considered to be ENCLOSURE LEAKAGE CURRENT . In the event of the interruption of any non-permanently installed PROTECTIVE EARTH CONDUCTOR or the equivalent conductor of a MULTIPLE PORTABLE SOCKET – OUTLET or of an equipment, the ENCLOSURE LEAKAGE CURRENT from or between parts of a SYSTEM within the PATIENT ENVIRONMENT shall not exceed 0,5 mA. If the SYSTEM or part of the SYSTEM is supplied from a MULTIPLE PORTABLE SOCKET – OUTLET , then the current in the PROTECTIVE EARTH CONDUCTOR of the MULTIPLE PORTABLE SOCKET – OUTLET shall not exceed 0,5 mA. 1 9.201 .2 P ATIENT LEAKAGE CURRENT In NORMAL CONDITION , the PATIENT LEAKAGE CURRENT shall not exceed 0,1 mA for TYPE B and BF APPLIED PARTS and 0,01 mA for TYPE CF APPLIED PARTS . Compliance with the requirements of 1 9.201 .1 and 1 9.201 .2 is checked by inspection and measurement of LEAKAGE CURRENTS using a measuring device as specified in 1 9.4e) of IEC 60601 -1 .