BS ISO 16571:2014

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Design requirements
6 Indicating systems
7 Plume extraction system pipeline
8 System components
9 Terminal units
10 Marking and colour coding
11 Pipeline installation
12 Testing, commissioning, and certification of
   the PES
13 Information to be supplied by the manufacturer
Annex A (informative) - Types of plume evacuation
        systems
Annex B (informative) - Healthcare facility policies
        and procedures
Annex C (informative) - Typical plume capture
        devices and transfer tubings
Annex D (informative) - Risk management checklist
Annex E (informative) - Operational management
Annex F (informative) - Rationale
Annex G (informative) - Example of procedure for
        testing and commissioning
        for a central system
Annex H (informative) - Guidelines for flow-generating
        devices consisting of fans or blowers
Bibliography

Defines 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.

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 portable and mobile plume evacuation systems, local stationary plume evacuation systems, dedicated central pipeline systems for plume evacuation systems, and 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: anaesthetic gas scavenging systems (AGSSs) which are covered in ISO7396-2; medical vacuum systems which are covered in ISO7396-1; heating, ventilation, and air-conditioning (HVAC) systems; aspects of laser safety other than airborne contamination; NOTE Some other aspects of laser safety are covered by IEC60825 (see Reference[7]). aspects of electrosurgery, electrocautery, and mechanical surgical tools other than airborne contamination produced by such equipment resulting from interaction with tissue or materials.