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CSA ISO 10079-3:14 (R2019)

Current

Current

The latest, up-to-date edition.

Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (Adopted ISO 10079-3:2014, third edition, 2014-05-01)

Available format(s)

Hardcopy , PDF

Language(s)

English, French

Published date

01-01-2014

Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Cleaning, disinfection and sterilization
6 Design requirements
7 Operational requirements
8 Physical requirements for field and transport use suction
   equipment
9 Performance requirements for vacuum level and flowrate
10 (*)Resistance to environment of suction equipment for field
   and/or transport use
11 Marking
12 Information to be supplied by the manufacturer
Annex A (normative) - Test methods
Annex B (informative) - Rationale statement
Annex C (informative) - Lumen size and its effect on flowrate
Annex D (informative) - Schematic of suction equipment
Bibliography

CSA Preface This is the second edition of CAN/CSA-ISO 10079-3, Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 10079-3 (third edition, 2014-05-01). It supersedes the previous edition published in 2003 as CAN/CSA-Z10079-3, Medical suction equipment - Part 3: Suction equipment powered from a vacuum or pressure source (adopted ISO 10079-3:1999, with Canadian deviations). 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 This part of ISO 10079 specifies safety and performance requirements for medical suction equipment powered from a vacuum or positive pressure gas source generating venture suction. It applies to equipment connected to medical gas pipeline systems or cylinders and venturi attachments. Annex D illustrates the three parts of ISO 10079 by providing a schematic for typical systems. The equipment can be stand-alone or part of an integrated system. Additional requirements for suction equipment intended for field and/or transport use are included in this part of ISO 10079. This part of ISO 10079 does not apply to the following: a) central power supply (by vacuum/compressed air generation), piping systems of vehicles and buildings, and wall connectors; b) end-piece such as suction catheters, Yankauer sucker and suction tips; c) syringes; d) dental suction equipment; e) anaesthetic gas scavenging systems; f) laboratory suction; g) autotransfusion systems; h) closed systems for wound drainage; i) mucus extractors, including neonatal mucus extractors; j) ventouse (obstetric) equipment; k) breast pumps; l) liposuction; m) uterine aspiration; n) plume evacuation systems.

DevelopmentNote
Supersedes CSA Z10079.3. (09/2014)
DocumentType
Standard
ISBN
978-1-77139-694-3
Pages
47
PublisherName
Canadian Standards Association
Status
Current
Supersedes

CSA Preface This is the second edition of CAN/CSA-ISO 10079-3, Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 10079-3 (third edition, 2014-05-01). It supersedes the previous edition published in 2003 as CAN/CSA-Z10079-3, Medical suction equipment - Part 3: Suction equipment powered from a vacuum or pressure source (adopted ISO 10079-3:1999, with Canadian deviations). 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 This part of ISO 10079 specifies safety and performance requirements for medical suction equipment powered from a vacuum or positive pressure gas source generating venture suction. It applies to equipment connected to medical gas pipeline systems or cylinders and venturi attachments. Annex D illustrates the three parts of ISO 10079 by providing a schematic for typical systems. The equipment can be stand-alone or part of an integrated system. Additional requirements for suction equipment intended for field and/or transport use are included in this part of ISO 10079. This part of ISO 10079 does not apply to the following: a) central power supply (by vacuum/compressed air generation), piping systems of vehicles and buildings, and wall connectors; b) end-piece such as suction catheters, Yankauer sucker and suction tips; c) syringes; d) dental suction equipment; e) anaesthetic gas scavenging systems; f) laboratory suction; g) autotransfusion systems; h) closed systems for wound drainage; i) mucus extractors, including neonatal mucus extractors; j) ventouse (obstetric) equipment; k) breast pumps; l) liposuction; m) uterine aspiration; n) plume evacuation systems.

Standards Relationship
ISO 10079-3:2014 Identical

ISO 8836:2014 Suction catheters for use in the respiratory tract
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
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-6:2010+AMD1:2013 CSV Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
ISO 5356-1:2015 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
ISO 10651-4:2002 Lung ventilators — Part 4: Particular requirements for operator-powered resuscitators
ISO 10079-1:2015 Medical suction equipment Part 1: Electrically powered suction equipment
IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
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
ISO 10079-2:2014 Medical suction equipment Part 2: Manually powered suction equipment
CGA V 5 : 2008(R2013) DIAMETER INDEX SAFETY SYSTEM (NON-INTERCHANGEABLE LOW PRESSURE CONNECTIONS FOR MEDICAL GAS APPLICATIONS)
ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
ISO 9170-1:2017 Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with compressed medical gases and vacuum
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
ISO 10524-1:2006 Pressure regulators for use with medical gases Part 1: Pressure regulators and pressure regulators with flow-metering devices
ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
ISO 18082:2014 Anaesthetic and respiratory equipment — Dimensions of non-interchangeable screw-threaded (NIST) low-pressure connectors for medical gases
ISO 7396-1:2016 Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum

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