CSA ISO 16571:16 (R2021)

CSA Preface

This is the first edition of CAN/CSA-ISO 16571, Systems for evacuation of plume generated by medical devices, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 16571 (first edition, 2014-03-15). At the time of publication, ISO 16571:2014 is available from ISO in English only. CSA Group will publish the French version when it becomes available from ISO.

This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group.

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.