AS 16571:2015 Systems for evacuation of plume generated by medical devices (ISO 16571:2014, MOD)
4.1 PESs shall, when installed, extended, modified, commissioned, operated, and maintained in accordance with the instructions of the manufacturer, present no risks that are not reduced to an acceptable level using risk management procedures in accordance with ISO 14971 and which are connected with their intended application, in normal condition and in single fault condition.
NOTE 1 A situation in which a fault is not detected is considered a normal condition. Fault conditions/hazardous situations can remain undetected over a period of time and as a consequence can lead to an unacceptable risk. In that case, a subsequent detected fault condition needs to be considered as a single fault condition. Specific risk control measures need to be determined within the risk management process to deal with such situations.
NOTE 2. Typical safety hazards are listed in Annex D.
4.2 The manufacturer can use type tests different from those described in this International Standard, if an equivalent degree of compliance can be demonstrated. However, in the event of dispute, the test arrangements and methods described in this International Standard shall be used as the reference methods.
5.3.3 The supply system shall be designed so that during maintenance on any source of supply or system component or during a single fault condition on any component of the system, the remaining sources and components shall be capable of supplying the system design flow.
5.3.4 Each source of supply shall have a control circuit arranged so that shutting off, or failure, of one source will not affect the operation of other source(s). The controls shall be arranged so that all the sources of supply service the system in turn or simultaneously. This requirement shall be met in normal condition and in single fault condition.
5.3.5 The supply system for a central PES should be connected to the emergency power supply. .
5.3.6 The exhaust(s) from the supply system shall be piped to the outside of the building and shall be provided with means to prevent the ingress of, for example, insects, debris, and precipitation. The location of the exhaust outlet should be remote from the air intake for medical air compressor systems, air intakes, doors, windows, or other openings in buildings. Consideration should be given to the potential effects of prevailing winds on the location of the exhaust(s).