This part of ISO 10079 specifies requirements for the safety and performance of vacuum or pressure source powered medical suction devices. It applies to devices connected to piping systems for medical gases or gas cylinders and suction nozzle accessories. Appendix D presents the three parts of ISO 10079, providing a schematic representation of typical systems. The devices can be standalone devices or part of an integrated system. Additional requirements for extraction devices for outdoor 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 supplies (through vacuum/compressed air generation), vehicle and building piping systems and wall connections; b) End pieces such as suction catheters, Yankauer suction devices and suction nozzles; c) syringes; d) dental suction devices; e) anesthesia gas delivery systems; f) laboratory suction; g) autotransfusion systems; h) closed systems for wound drainage; (i) oral mucus aspirators, including neonatal mucus aspirators; j) obstetric equipment; k) breast pumps; l) liposuction; m) suction from the uterus; n) Smoke extraction systems.
EN ISO 10079-3:2014 Referenced Document
IEC 60601-1-6:2010 Medical electrical equipment - General requirements for basic safety and essential performance - Collateral Standard: Usability
IEC 62366:2007 Medical devices - Application of usability engineering to medical devices
ISO 10079-1:1999 Medical suction equipment - Part 1: Electrically powered suction equipment - Safety requirements
ISO 10079-2:2014 Medical suction equipment - Part 2: Manually powered suction equipment
ISO 10524-1:2006 Pressure regulators for use with medical gases - Part 1: Pressure regulators and pressure regulators with flow-metering devices
ISO 10651 Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 6: Home-care ventilatory support devices
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
ISO 5356-1:2004 Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets
ISO 5359:2008 Low-pressure hose assemblies for use with medical gases
ISO 7000:2014 Graphical symbols for use on equipment - Registered symbols
ISO 7396-1:2007 Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum
ISO 8836:2007 Suction catheters for use in the respiratory tract
ISO 9170-1:2008 Terminal units for medical gas pipeline systems - Part 1: Terminal units for use with compressed medical gases and vacuum
EN ISO 10079-3:2014 history
2022EN ISO 10079-3:2022 Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (ISO 10079-3:2022)
2014EN ISO 10079-3:2014 Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source (ISO 10079-3:2014)
2009EN ISO 10079-3:2009 Medical suction equipment - Part 3: Suction equipment powered from a vacuum or pressure source
1999EN ISO 10079-3:1999 Medical Suction Equipment - Part 3: Suction Equipment Powered from Vacuum or Pressure Source ISO 10079-3 : 1999
1996EN ISO 10079-3:1996 Medical Suction Equipment - Part 3: Suction Equipment Powered from Vacuum or Pressure Source ISO 10079-3 : 1992