This International standard EN 15001 specifies the requirements for the oxygen compatibility of materials, components and devices for anesthetic and respiratory applications that may be in contact with oxygen in the normal state or single fault condition at gas pressures greater than 50 kPa.
In addition, this International Standard provides general guidelines for performing a risk analysis, including the selection of materials and components based on available data on oxygen compatibility, and addressing the toxicity of combustion and/or decomposition products.
Compatibility aspects addressed by this International Standard include cleanliness, resistance to ignition, and toxicity of combustion and/or decomposition products during design, manufacture, maintenance and disposal.
This International Standard does not apply to biocompatibility. This International Standard applies to anesthetic and respiratory equipment covered by ISO/TC 121, eg medical gas pipeline systems, pressure regulators, terminal units, medical supply units, flexible connectors, flow meters, anesthetic workstations and lung ventilators.
Our organization also provides testing services to enterprises within the scope of laboratory services, within the scope of EN 15001 Oxygen Compatibility Requirements.
To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.
EUROLABreporting and certification activities, United Accreditation Foundation (UAF), Turkish Accreditation Agency (TÜRKAK) ve Enterprise Accreditation Foundation (EAF) based on the accreditation provided by the accreditation body. The Enterprise Accreditation Foundation (EAF) accreditation body is also a signatory of the United Nations (UN GLOBAL COMPACT) organization.
