CAN/CSA-ISO 10079-1:16

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.