SNZ - AS/NZS 3551
Technical management programs for medical devices
|Publication Date:||11 June 2004|
This Standard outlines procedures required to develop management programs for medical equipment. These include protocols and procedures for procurement, acceptance, maintenance activities throughout the service life of the medical equipment, and finally disposal of medical equipme
This Standard applies to non-electrical medical equipment, such as ventilators, which may be solely pneumatic or fluidic in operation, as well as medical electrical equipment. Also included in the scope are products that are not generally considered to be medical equipment, but are used in the patient environment, such as computers, imaging cameras and recorders.
This Standard applies whether the medical equipment is owned by the responsible organization, privately owned, on loan, on hire, on trial or donated, and includes medical equipment provided by a responsible organization as part of a pool of medical equipment for hire. It does not apply to the electrical commissioning requirements of permanently installed medical electrical devices as specified in AS/NZS 3003.
Although this Standard is focused on the management of medical equipment within an organization, it is acknowledged that some responsible organizations may choose to use many of the protocols and procedures of this document to manage medical equipment in other areas, for example laboratories. In such circumstances, the organization, or its service entity, will have to consider the relevance of some of the requirements outlined in this document.
In developing this Standard, reference has been made to manufacturer's specifications for a wide range of commercially available medical equipment. It is not possible in this Standard to address every type of medical equipment, particularly since new treatment modalities and medical equipment will be marketed during the life of the Standard. It is therefore important to make reference to manufacturer's specifications for the operation, performance testing and calibration of any new medical equipment, and to balance this with a knowledge of professional biomedical engineering practice for similar equipment
Where the acceptance values of an AS/NZS 3200 Part 2 Standard for a particular type of medical electrical equipment are not in agreement with the requirements of AS/NZS 3200.1.0:1998 or IEC 60601-1, Ed. 3.0 (2005), the requirements of the Part 2 Standard override these documents. For example, the normal limit (specified in AS/NZS 3200.1.0) for mains contact current is 50 μA per Applied Part, while AS/NZS 3200.2.4 specifies an allowable current of 100 μA for Type CF defibrillator Applied Parts. It should also be noted that, in some instances, allowable limits applicable for acceptance testing may be more stringent than for ongoing performance verification.