| ISO 10079-3 Third Edition 2014-05-01 Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source |
| Recognition Number | Anesthesiology |
| Recognition Date | 2018-06-07 |
| Recognition List | 049 |
| Recognition Number | 1-133 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | Anesthesiology |
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This standard is relevant to medical devices and is recognized because it is scientifically and technically valid and not in conflict with existing regulatory policies.
ISO 10079-3:2014 specifies safety and performance requirements for medical suction equipment powered from a vacuum or positive pressure gas source generating venturi suction. It applies to equipment connected to medical gas pipeline systems or cylinders and venturi attachments.
The equipment can be stand-alone or part of an integrated system.
| Regulation Number | Device Name | Device Class | Product Code |
| §880.6740 | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | Class 2 | GCX |
| §880.6740 | Bottle, Collection And Trap, Breathing System (Uncalibrated) | Class 2 | CBC |
| §880.6740 | Bottle, Collection, Breathing System (Calibrated) | Class 2 | CBD |
| §880.6740 | Bottle, Collection, Vacuum | Class 2 | KDQ |
| §880.6740 | Chest Drainage Kit | Class 2 | PAD |
| §880.6740 | Regulator, Vacuum | Class 2 | KDP |
| §878.5040 | System, Suction, Lipoplasty | Class 2 | MUU |
| §878.4780 | Negative Pressure Wound Therapy Powered Suction Pump | Class 2 | OMP |
| §878.4780 | Pump, Portable, Aspiration (Manual Or Powered) | Class 2 | BTA |
| §878.4780 | Vacuum Powered Body Fluid Collection Kit | Class 2 | OJR |
| §878.4780 | Wound Drain Catheter System | Class 2 | OTK |
| §874.5350 | Device, Antichoke, Suction | Class 3 | EWT |
| §870.5910 | Esophageal Thermal Regulation And Gastric Suctioning Device | Class 2 | PLA |
| §870.5050 | Apparatus, Suction, Patient Care | Class 2 | DWM |
| Guidance for Industry and FDA Reviewers/Staff: Guidance Document for Powered Suction Pump 510(k)s. Issued September 1998. |