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  • BSI
    BS ISO 16571:2014 Systems for evacuation of plume generated by medical devices
    Edition: 2014
    $500.66
    / user per year

Description of BS ISO 16571:2014 2014

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

  1. portable and mobile plume evacuation systems,

  2. local stationary plume evacuation systems,

  3. dedicated central pipeline systems for plume evacuation systems, and

  4. 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:

  1. anaesthetic gas scavenging systems (AGSSs) which are covered in ISO 7396-2;

  2. medical vacuum systems which are covered in ISO 7396-1;

  3. heating, ventilation, and air-conditioning (HVAC) systems;

  4. aspects of laser safety other than airborne contamination;

    NOTE Some other aspects of laser safety are covered by IEC 60825 (see Reference[7]).

  5. aspects of electrosurgery, electrocautery, and mechanical surgical tools other than airborne contamination produced by such equipment resulting from interaction with tissue or materials.



Standard NumberBS ISO 16571:2014
TitleSystems for evacuation of plume generated by medical devices
StatusWithdrawn
Publication Date2014-05-31
Withdrawn Date2024-04-17
Identical National Standard OfISO 16571:2014
DescriptorsMedical equipment, Medical instruments, Risk analysis, Clinical investigation instruments, Risk assessment, Hazards, Safety measures, Management, Diagnosis (medical)
ICS11.040.10 Anaesthetic, respiratory and reanimation equipment
CommitteeCH/121/6
ISBN978 0 580 74675 8
PublisherBSI
Pages50

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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