Systems for evacuation of plume generated by medical devices

Designation Number:
CAN/CSA-ISO 16571:16
Standard Type:
National Standard of Canada - Adoption of International Standard
Standard Development Activity:
Reaffirmation
ICS code(s):
11.040.10
Status:
Proceeding to development
SDO Comment Period Start Date:
SDO Comment Period End Date:
Posted On:

Scope:

Scope

1.1 This International Standard specifies requirements and guidelines for the design, manufacture, 
installation, function, performance, maintenance, servicing, documentation, testing, and commissioning 
of equipment for evacuation of plume generated by medical devices.
NOTE A plume evacuation system (PES) can be a functionally independent component of a medical device 
that has other functions.
1.2 This International Standard is applicable to
a) portable and mobile plume evacuation systems,
b) local stationary plume evacuation systems,
c) dedicated central pipeline systems for plume evacuation systems, and
d) plume evacuation systems integrated into other equipment (e.g. laser equipment).
1.3* This International Standard does not apply to active and passive devices used to evacuate plume 
generated during invasive (e.g. laparoscopic or endoscopic) procedures.
1.4 This International Standard does not apply to the following:
a) anaesthetic gas scavenging systems (AGSSs) which are covered in ISO 7396-2;
b) medical vacuum systems which are covered in ISO 7396-1;
c) heating, ventilation, and air-conditioning (HVAC) systems;
d) aspects of laser safety other than airborne contamination;
NOTE Some other aspects of laser safety are covered by IEC 60825 (see Reference[7]).
e) aspects of electrosurgery, electrocautery, and mechanical surgical tools other than airborne 
contamination produced by such equipment resulting from interaction with tissue or materials.

Project need:

Project Need
To review the Standard within the required 5 year period

Note: The information provided above was obtained by the Standards Council of Canada (SCC) and is provided as part of a centralized, transparent notification system for new standards development. The system allows SCC-accredited Standards Development Organizations (SDOs), and members of the public, to be informed of new work in Canadian standards development, and allows SCC-accredited SDOs to identify and resolve potential duplication of standards and effort.

Individual SDOs are responsible for the content and accuracy of the information presented here. The text is presented in the language in which it was provided to SCC.