EN ISO 15001:2011

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Cleanliness
5 Resistance to ignition
6 Risk management
Annex A (informative) - Examples of cleaning procedures
Annex B (informative) - Typical methods for validation of
        cleaning procedures
Annex C (informative) - Design considerations
Annex D (informative) - Selection of materials
Annex E (informative) - Recommended method for combustion
        and quantitative analysis of combustion products of
        non-metallic materials
Annex F (informative) - Rationale
Bibliography
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements of EU
         Directive 93/42/EEC

ISO 15001:2010 specifies requirements for the oxygen compatibility of materials, components and devices for anaesthetic and respiratory applications, which can come into contact with oxygen in normal condition or in single fault condition at gas pressures greater than 50 kPa.Additionally, ISO 15001:2010 gives general guidelines for the selection of materials and components based on available data on their oxygen compatibility, and for carrying out a risk analysis, including addressing the toxicity of products of combustion and/or decomposition.Aspects of compatibility that are addressed by ISO 15001:2010 include cleanliness, resistance to ignition and the toxicity of products of combustion and/or decomposition at the design, manufacturing, maintenance and disposal stages.ISO 15001:2010 is applicable to anaesthetic and respiratory equipment that is within the scope of ISO/TC 121, e.g. medical gas pipeline systems, pressure regulators, terminal units, medical supply units, flexible connections, flow-metering devices, anaesthetic workstations and lung ventilators.