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BS EN ISO 16571:2024

BS EN ISO 16571:2024

$189.07

Systems for evacuation of plume generated by medical devices

Published By Publication Date Number of Pages
BSI 2024 46
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This document specifies requirements and guidelines for systems and equipment used to evacuate plume generated by medical devices.  This document applies to all types of plume evacuation systems (PESs), including a)       portable; b)       mobile; c)        stationary, including dedicated central pipelines; d)       PESs integrated into other equipment; e)       PESs for endoscopic procedures (e.g., minimally invasive, laparoscopic) This document applies to all healthcare facilities where PESs are used, including, but not limited to a)       surgical facilities; b)       medical offices; c)        cosmetic treatment facilities; d)       medical teaching facilities; e)       dental clinics; f)         veterinary facilities. This document provides guidance on the following aspects of PESs: a)       importance; b)       purchasing; c)        design; d)       manufacture; e)       documentation; f)         function; g)       performance; h)       installation; i)         commissioning; j)         testing; k)       training; l)         use; m)     risk assessment; n)       servicing; o)       maintenance. This document 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; and e)       aspects of electrosurgery, electrocautery, and mechanical surgical tools other than airborne contamination produced by such equipment resulting from interaction with tissue or materials.

PDF Catalog

PDF Pages PDF Title
2 undefined
4 European foreword
Endorsement notice
6 Foreword
7 Introduction
9 1 Scope
10 2 Normative references
3 Terms and definitions
15 4 General requirements
4.1 Components
4.2 Systems
16 4.3 Capture device
17 4.4 Transfer tubing
4.5 Filtration subsystem
4.6 Control subsystem
4.7 Flow-generator
18 4.8 Exhaust subsystem
4.9 Colour coding
5 Portable and mobile system requirements
5.1 General requirements
5.2 Acoustic noise test
20 5.3 Ingress protection
6 Stationary and pipeline system requirements
6.1 Stationary plume evacuation systems
6.2 Design
21 6.3 Flow-generators
6.4 Exhausts
6.5 Flow-generator controls
22 6.6 Pipeline
6.7 Terminal units
6.8 Commissioning and testing
23 7 Endoscopic and laparoscopic system requirements
7.1 Active PESs
7.2 Passive PESs
25 Annex A (informative) Rationale
28 Annex B (informative) Plume evacuation system implementation
31 Annex C (normative) Plume removal efficiency test method
37 Annex D (normative) Colour coding
40 Annex E (normative) Information to be supplied to the healthcare facility
43 Annex F (informative) Acoustic testing muffler design
45 Bibliography

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BS EN ISO 16571:2024
$189.07