The full title of this standard is AS/NZS 3551:2012 Management Programs for Medical Equipment and can be purchased from Standards NZ.
Below are several extracts from the Standard which broadly out line what is required. This extract is provided by Standards NZ under licence 001147
The safe application of medical equipment depends on a variety of factors. The minimum requirements are as follows:
- (a) Medical electrical equipment is used only in a patient area provided with appropriate protection and the reticulated mains wiring in accordance with AS/NZS3003, Electrical installations—Patient areas.
- (b) Appropriate equipment is used for each particular application and in accordance with an appropriate set of rules linking the type of procedure with the class of medical equipment and the electrical safety facilities provided in the patient area.
(c) Each new item of equipment is—
- (i) acceptance tested prior to clinical use;
- (ii) subjected to routine performance verification during its useable life to detect damage, wear, component failure or changed component value which might render it unsafe; and
- (iii) maintained with reference to the manufacturer’s instructions using formal risk analysis within a risk management framework.
(d) The users of the medical equipment must know, not only the medical procedure, but also the safety characteristics and operational details of the medical equipment. This can be achieved by learning and training under the supervision of the manufacturer, the local representative, experienced users, or staff from biomedical engineering departments or the service entity.
(e) The responsible organization needs to ensure that safety and performance of the medical equipment is maintained by an effective maintenance scheme with regular assessment, testing and maintenance in accordance with this Standard.