Standards Development

Scope

This document specifies terminology, classification, requirements and test methods for portable suction equipment primarily intended to be used by dental professionals in non-permanent healthcare environments.

This document specifies requirements for information to be supplied by the manufacturer on the performance, operation and maintenance of portable suction equipment designed and constructed to be transported for use in non-permanent healthcare environments.

This document does not apply to stationary suction equipment, mobile suction equipment or portable suction equipment that is intended to be used in clinical settings or not designed to be disassembled or packed for human transport between non-permanent healthcare environments. Also, requirements for stationary suction equipment that may be installed in a dental mobile medical facility (e.g., vehicular or containerized mobile dental clinic) are not considered in this document

This document specifies requirements for portable suction equipment used to provide reduced pressure and flow at the cannula connector.

This document does not apply to portable suction equipment used for life support or for scavenging halogenated anaesthetic gases.

Purpose

A number of trends in health care have driven increased utilization of portable dental equipment in non-clinical settings. Military forces use portable dental equipment in support of mobilized forces or for humanitarian outreach. A variety of government and non-government organizations are increasingly providing humanitarian dental care to underserved populations and populations affected by disasters. Civilian health care workers are also increasingly providing dental services to a growing population who are simply unable to visit traditional dental clinics due to age, disability, or income.

The transport and end-use conditions for portable dental equipment used in non-clinical settings drive certain unique requirements which generally do not apply to portable, mobile or stationary dental equipment used in traditional dental clinics or hospitals. Because portable equipment used in non-clinical settings is intended to be moved between venues, in some cases carried over rugged terrain or in inclement conditions, it must be designed and constructed to be safely transported by humans without damage, be efficiently assembled and disassembled, and deliver reliable service at the point of use. Special consideration must be given to the austerity of the environment in which the equipment may be used and the availability and quality of utility supplies (electrical power, water, compressed air, etc.). In order for the equipment to be sufficiently portable and capable of operating in extreme conditions, certain requirements for dental equipment intended for use in traditional clinical settings may not be practical and must be reconsidered for portable dental equipment for use in non-clinical settings. There can also be unique safety and infection control concerns to consider.

Consider the following:

Is there a verified market need for the proposal?

What problem does this document solve?

What value will the document bring to end-users?

See Annex C of the ISO/IEC Directives part 1 for more information.

See the following guidance on justification statements in the brochure ‘Guidance on New work’: https://www.iso.org/publication/PUB100438.html