NF S95-186-2-69:2014 Medical electrical equipment - Part 2-69 : particular requirements for basic safety and essential performance of oxygen concentrator equipment
This particular Standard specifies the requirements applicable to the BASIC SAFETY and ESSENTIAL PERFORMANCES of an OXYGEN CONCENTRATOR in combination with its ACCESSORIES, hereinafter referred to as ME EQUIPMENT, aimed at increasing the oxygen concentration of the gas intended to be delivered to a single PATIENT. Such OXYGEN CONCENTRATORS are, in general, intended for use in a HOME CARE ENVIRONMENT, and are also OPERATIONAL ON THE GO for a single PATIENT in various environments, in public and private transportation as well as in air transportation.
NF S95-186-2-69:2014 Referenced Document
ISO 14937 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
ISO 15223-1 Medical devices-Symbols to be used with information to be supplied by the manufacturer-Part 1: General requirements
ISO 17664 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices*， 2017-09-30 Update
ISO 3744 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 7000 Graphical symbols for use on equipment — Index and synopsis*， 2019-07-12 Update
ISO 80369-1 Small-bore connectors for liquids and gases in healthcare applications — Part 1: General requirements*， 2018-11-05 Update
NF S95-186-2-69:2014 history
2020NF S95-186-2-69:2020 Medical electrical equipment - Part 2-69 : particular requirements for the basic safety and essential performance of oxygen concentrator equipment
2014NF S95-186-2-69:2014 Medical electrical equipment - Part 2-69 : particular requirements for basic safety and essential performance of oxygen concentrator equipment
2012NF S95-143/A1:2012 Oxygen concentrators for medical use - Safety requirements - Amendment 1
2009NF S95-143:2009 Oxygen concentrators for medical use - Safety requirements.
1997NF S95-143:1997 Oxygen concentrators for medical use. Safety requirements.