Jeff, AS/NZS 3200.1.1 covers the safety requirements for medical electrical systems.
Below is a partial extract from standard which I hope helps to answer your email below. But please read the whole standard to obtain all the necessary information (click on http://www.saiglobal.com/shop/script/Details.asp?DocN=stds000013050 to obtain standard from Standards Australia) as the below as mentioned is a partial extract from the standard. The note under the scope is very important because as it states the party who creates the system is responsible for making sure the system complies with the standard. As a question to the BME community, is this being done in your department? 1 Scope and object *1.201 Scope This standard applies to the safety of MEDICAL ELECTRICAL SYSTEMS, as defined in 2.203. It describes the safety requirements necessary to provide protection for the PATIENT, the OPERATOR and surroundings. NOTE ? It is presumed that the party assembling or modif ying the MEDICAL ELECTRICAL SYSTEMS will take the necessary steps to assure compliance with this standard. *2.203 MEDICAL ELECTRICAL SYSTEM (hereinafter referred to as a SYSTEM): Combinationof either more than one item of MEDICAL ELECTRICAL EQUIPMENT or MEDICAL ELECTRICAL EQUIPMENT and other non-medical electrical equipment having a specified function and inter-connected by: - COUPLING, and/or - aMULTIPLE PORTABLE SOCKET-OUTLET. NOTE - The SYSTEM includes those accessories which are needed for operating the SYSTEM and are to be specif ied by the manufacturer. (See also examples given in annexes BBB and FFF.) 19 Continuous LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS *19.201 LEAKAGE CURRENTS 19.201.1 ENCLOSURE LEAKAGE CURRENT In NORMAL CONDITION the allowable ENCLOSURE LEAKAGE CURRENT from or between parts of the SYSTEM within the PATIENT ENVIRONMENT shall not exceed 0,1 mA. In the event of the interruption of any non-permanently installed protective earth conductor the allowable ENCLOSURE LEAKAGE CURRENT from or between parts of a SYSTEM within the PATIENT ENVIRONMENT shall not exceed 0,5 mA. If the SYSTEM includes a MULTIPLE PORTABLE SOCKET- z OUTLET the ENCLOSURE LEAKAGE CURRENT shall also be measured from parts which are in z NORMAL CONDITION protectively earthed. z 19.201.2 PATIENT LEAKAGE CURRENT In NORMAL CONDITION the PATIENT LEAKAGE CURRENT shall not exceed 0,1 mA for TYPE B and BF EQUIPMENT and 0,01 mA for TYPE CF EQUIPMENT. Compliance with the requirements of subclauses 19.201.1 and 19.201.2 is checked by inspection and measurement of LEAKAGE CURRENTS using a device according to IEC 601-1, subclause 19.4 e). 19.201.3 Connection of SIGNAL INPUT PARTS or SIGNAL OUTPUT PARTS (see also annex BBB) If compliance of the MEDICAL ELECTRICAL EQUIPMENT with subclause 19.2 b) first dash and/or 19.2 c) of IEC 601-1 is achieved by specifying that the SIGNAL INPUT PART and/or SIGNAL OUTPUT PART is for exclusive connection to equipment as specified in the ACCOMPANYING DOCUMENTS, then the SIGNAL INPUT PART and/or SIGNAL OUTPUT PART shall be connected: - either to such equipment which, if CLASS I, is connected to the common PROTECTIVE EARTH of the SYSTEM, - ortoaSEPARATION DEVICE. Compliance is checked by inspection. Regards, Scott Wedesweiler, Engineering Officer ? Electromedical 14 Nelson Street, Chatswood NSW 2067, Sydney, Australia tel: 61 2 9410 5111 fax: 61 2 9415 1567 Testing & Certification Australia, a business of EnergyAustralia Customer Comments/Feedback Form P Please consider the environment before printing this email. jeff.merri...@nt.gov.au 21/05/2009 12:19 PM To "bmelist@bme.asn.au" <bmelist@bme.asn.au> cc Subject [bmelist] RE: Earth Leakage We have a central monitoring system comprising a PC, display and UPS in a nurses station, central to the room and is also raised, which monitors 4 x bedside patient monitors and the earth leakage for the central monitoring system is 0.590 amps for normal and 1.161 amps for single fault (neutral open). The note at the end of para 1.4.11 in AS/NZS 3551 states it is part of the medical equipment system so therefore should be treated as such but it isn't in an area that patients are treated . Any thaughts/remedies? Regards Jeff Merrigan RDH Test & Commissioning Officer Ph 08 89228423 Fax 08 89228712 email: "jeff.merri...@nt.gov.au" To unsubscribe from the bmelist, send a blank email from the subscribed address to bmelist-unsubscr...@bme.asn.au ---------------------------------------------------------------------------------------- This e-mail may contain confidential or privileged information. If you have received it in error, please notify the sender immediately via return e-mail and then delete the original e-mail. EnergyAustralia has collected your business contact details for dealing with you in your business capacity. More information about how we handle your personal information, including your right of access is contained at http://www.energy.com.au.
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