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CAN/CSA-ISO 10079-1:16

Current
Current

The latest, up-to-date edition.

Medical suction equipment - Part 1: Electrically powered suction equipment (Adopted ISO 10079-1:2015, third edition, 2015-11-01)
Available format(s)

Hardcopy , PDF

Language(s)

English - French, French

Published date

01-01-2016

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 suction equipment for
   field use
9 Performance requirements for vacuum level and
   flowrate
10 Resistance to environment of suction equipment
   for field and/or transport use
11 Information to be supplied by the manufacturer
   (labelling and instructions for use)
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

Defines safety and performance requirements for electrically powered medical and surgical suction equipment.

CSA Preface This is the second edition of CAN/CSA-ISO 10079-1, Medical suction equipment Part 1: Electrically powered suction equipment, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 10079-1 (third edition, 2015-11-01). It supersedes the previous edition published in 2003 as CAN/CSA-Z10079-1 (adopted ISO 10079-1:1999). For brevity, this Standard will be referred to as "CAN/CSA-ISO 10079-1" throughout. Scope This part of ISO 10079 specifies safety and performance requirements for electrically powered medical and surgical suction equipment. It applies to equipment used in health care facilities such as hospitals, for domiciliary care of patients and for field and transport use. 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-pieces such as suction catheters, drains, curettes, Yankauer suckers and suction tips; c) syringes; d) dental suction equipment; e) anaesthetic gas scavenging systems; f) laboratory suction; g) autotransfusion systems; h) mucus extractors including neonatal mucus extractors; i) suction equipment where the collection container is downstream of the vacuum pump; j) ventouse (obstetric) equipment; k) suction equipment marked for endoscopic use only; l) plume evacuation systems.

DevelopmentNote
Supersedes CSA Z10079.1. (07/2016)
DocumentType
Standard
ISBN
978-1-4883-0640-2
Pages
64
ProductNote
NEW CHILD AMD 1 2019 IS NOW ADDED
PublisherName
Canadian Standards Association
Status
Current
Supersedes

Standards Relationship
ISO 10079-1:2015 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
IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices
IEC TR 60878:2015 Graphical symbols for electrical equipment in medical practice
ISO 10079-2:2014 Medical suction equipment Part 2: Manually powered suction equipment
IEC 60529:1989+AMD1:1999+AMD2:2013 CSV Degrees of protection provided by enclosures (IP Code)
ISO 10079-3:2014 Medical suction equipment Part 3: Suction equipment powered from a vacuum or positive pressure gas source
ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements

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