| ISO 80601-2-69 First edition 2014-07-15 Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment |
| Recognition Date | 2015-01-27 |
| Recognition List | 038 |
| Recognition Number | 1-102 |
| Extent | Partial recognition. The following part(s) of the standard is (are) not recognized Clause 201.12.4.103 Delivered gas filter |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | Anesthesiology |
| FDA Tech | Nam To FDA/OMPT/CDRH/ODE/DAGID/ANDB/ 301-796-4634 Ka.To@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
ISO 80601-2-69:2014 specifies requirements for the basic safety and essential performance of an oxygen concentrator in combination with its accessories, hereafter referred to as ME equipment, intended to increase the oxygen concentration of gas intended to be delivered to a single patient. Such oxygen concentrators are typically intended for use in the home healthcare environment, including transit-operable use by a single patient in various environments including any private and public transportation as well as in commercial aircraft.
ISO 80601-2-69:2014 is applicable to a transit-operable and non-transit-operable oxygen concentrator. It is applicable to an oxygen concentrator integrated into or used with other medical devices, ME equipment or ME systems.
| Regulation Number | Device Name | Device Class | Product Code |
| §868.5440 | Generator, Oxygen, Portable | Class 2 | CAW |
| There is no relevant guidance developed at this time. |