Anaesthetic and respiratory equipment – Compatibility with oxygen (ISO 15001:2010)
Abstract
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.
DIN EN ISO 15001:2012-06 (E)
Anaesthetic and respiratory equipment – Compatibility with oxygen (ISO 15001:2010)
Contents Page
Foreword ………………………………………………………………………………………………………………………………………. 3
Introduction …………………………………………………………………………………………………………………………………… 4
1* Scope …………………………………………………………………………………………………………………………….. 5
2 Normative references …………………………………………………………………………………………………….. 5
3 Terms and definitions …………………………………………………………………………………………………….. 5
4 Cleanliness ……………………………………………………………………………………………………………………. 6
5* Resistance to ignition …………………………………………………………………………………………………….. 7
6 Risk management …………………………………………………………………………………………………………… 7
Annex A (informative) Examples of cleaning procedures ……………………………………………………………….. 8
Annex B (informative) Typical methods for validation of cleaning procedures ………………………………. 15
Annex C (informative) Design considerations ………………………………………………………………………………. 18
Annex D (informative) Selection of materials ………………………………………………………………………………… 23
Annex E (informative) Recommended method for combustion and quantitative analysis of
combustion products of non-metallic materials …………………………………………………………….. 36
Annex F (informative) Rationale …………………………………………………………………………………………………… 41
Bibliography ………………………………………………………………………………………………………………………………… 42
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42 EEC ………………………………………………………………………. 45