• There are no items in your cart

BS ISO 16571:2014

Current
Current

The latest, up-to-date edition.

Systems for evacuation of plume generated by medical devices
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

05-31-2014

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.

Committee
CH/121/6
DevelopmentNote
Supersedes 13/30242951 DC. (05/2014)
DocumentType
Standard
Pages
50
PublisherName
British Standards Institution
Status
Current
Supersedes

Standards Relationship
ISO 16571:2014 Identical

CSA Z305.13 : 2013(R2018) PLUME SCAVENGING IN SURGICAL, DIAGNOSTIC, THERAPEUTIC, AND AESTHETIC SETTINGS
CSA Z317.2 : 2010 SPECIAL REQUIREMENTS FOR HEATING, VENTILATION, AND AIR-CONDITIONING (HVAC) SYSTEMS IN HEALTH CARE FACILITIES
ISO 3744:2010 Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Engineering methods for an essentially free field over a reflecting plane
Z7396.1-17 Medical gas pipeline systems - Part 1: Pipelines for medical gases, medical vacuum, medical support gases, and anaesthetic gas scavenging systems
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
ISO 15001:2010 Anaesthetic and respiratory equipment Compatibility with oxygen
ISO 5356-1:2015 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
ISO 7396-2:2007 Medical gas pipeline systems Part 2: Anaesthetic gas scavenging disposal systems
IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
CSA Z7396.2 : 2002 MEDICAL GAS PIPELINE SYSTEMS - PART 2: ANAESTHETIC GAS SCAVENGING DISPOSAL SYSTEMS
ISO 5359:2014 Anaesthetic and respiratory equipment Low-pressure hose assemblies for use with medical gases
EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
CSA Z386:2014(R2019) SAFE USE OF LASERS IN HEALTH CARE
ISO 11197:2016 Medical supply units
IEC 60529:1989+AMD1:1999+AMD2:2013 CSV Degrees of protection provided by enclosures (IP Code)
ANSI Z136.3 : 2011 SAFE USE OF LASERS IN HEALTH CARE
NFPA 115 : 2016 LASER FIRE PROTECTION
ISO 80369-1:2010 Small-bore connectors for liquids and gases in healthcare applications Part 1: General requirements
C22.1HB-15 Canadian Electrical Code Handbook - An Explanation of the Rules of the Canadian Electrical Code, Part I
EN 1822-1:2009 High efficiency air filters (EPA, HEPA and ULPA) - Part 1: Classification, performance testing, marking
ISO 14971:2007 Medical devices Application of risk management to medical devices
EN 13348:2016 Copper and copper alloys - Seamless, round copper tubes for medical gases or vacuum
ISO 7396-1:2016 Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum

View more information
US$313.84
Excluding Tax where applicable

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.