ISO 15000-1:2004 Certification
Oxygen Compatibility Certification for Medical Devices
ISO 15000-1:2004 specifies requirements for the oxygen compatibility of materials, components and devices used in anaesthetic and respiratory applications that may come into contact with oxygen at gas pressures greater than 50 kPa - including breathing attachments, anaesthetic machines, airways, respiratory devices, medical gas supply systems, suction devices and connectors. International Assessment Bureau carries out independent, impartial audits against the standard's requirements.
What ISO 15000-1:2004 Covers
Equipment In Scope
Breathing attachments, anaesthetic machines, airways, respiratory devices, medical gas supply systems, suction devices and connectors used in oxygen-contact applications.
Oxygen Compatibility Requirements
Limits on hydrocarbon and particle contamination, resistance to ignition, and risk management for materials and components.
Material & Component Selection
Guidelines for selecting materials and components based on oxygen compatibility data, supported by informative annexes on cleaning, system design and test methods.
Not a Biocompatibility Standard
Addresses cleanliness, ignition resistance and toxicity of combustion products - it does not cover biocompatibility.
What ISO 15000-1:2004 Does For Your Organisation
Our Certification Process at a Glance
Application & Quote
Tell us about your organisation, products and scope. We provide a clear, fixed quote.
Payment & Invoice
Once you accept the quote, we issue an invoice and confirm your certification agreement before scheduling the audit.
Stage 1, Stage 2 & Surveillance Audits
Review of material selection, cleaning procedures and risk management documentation against the standard, followed by ongoing surveillance audits.
Certification Decision
An independent technical review confirms the certification decision.
Certificate & Surveillance
Certificate issued, with ongoing surveillance audits to keep it valid.
See our full certification process for more detail on each stage.
About ISO 15000-1:2004
International Assessment Bureau is an independent certification body based in the UK. Oxygen, pure or mixed with other medical gases, is widely used in medical applications, and patients and clinical personnel are often in close proximity to the devices that use it. If a fire occurs in an oxygen-enriched atmosphere the risk of serious injury is high - commonly triggered by heat from adiabatic compression where hydrocarbon or particulate contamination is present. Some combustion products from non-metallic materials such as plastics, elastomers and lubricants are toxic, which can put patients at risk even when they are remote from the equipment but receiving oxygen through a medical gas pipeline system, and can also damage or disrupt other nearby equipment that relies on oxygen.
Reducing or avoiding these risks depends on choosing appropriate materials, following correct cleaning procedures, and designing and constructing equipment so that it is compatible with oxygen under its conditions of use. ISO 15000-1:2004 gives recommendations for selecting materials and cleaning the components made from them for use in oxygen and oxygen-enriched atmospheres. ISO itself issues no certification or conformity test directly - particular device standards often reference ISO 15000-1:2004 as a horizontal standard and may strengthen these minimum requirements further. Certification against ISO 15000-1:2004 is carried out by certification bodies such as International Assessment Bureau. If you are planning to get your products certified, get in touch with our team.
Ready to Start Your ISO 15000-1:2004 Certification?
Tell us about your organisation and we'll come back with a clear, no-obligation quote.