| ISO 10079-1 Third Edition 2015-11-01 Medical suction equipment - Part 1: Electrically powered suction equipment |
| Recognition Number | Anesthesiology |
| Recognition Date | 2018-06-07 |
| Recognition List | 049 |
| Recognition Number | 1-131 |
| 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 10079-1:2015 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.
ISO 10079-1:2015 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.
| Regulation Number | Device Name | Device Class | Product Code |
| §878.5040 | System, Suction, Lipoplasty | Class 2 | MUU |
| §878.4780 | Apparatus, Suction, Ward Use, Portable, Ac-Powered | Class 2 | JCX |
| §878.4780 | Pump, Portable, Aspiration (Manual Or Powered) | Class 2 | BTA |
| §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. |