BS EN ISO 15001:2010 Anaesthetic and respiratory equipment. Compatibility with oxygen
BS EN ISO 15001 is the standard that 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.
BS EN ISO 15001 also 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 BS EN ISO 15001 include cleanliness, resistance to ignition and the toxicity of products of combustion and/or decomposition at the design, manufacturing, maintenance and disposal stages.
BS EN ISO 15001 does not apply to biocompatibility. It 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.
Contents of BS EN ISO 15001 include
- Scope
- Normative references
- Terms and definitions Cleanliness
- Resistance to ignition
- Risk management
- Examples of cleaning procedures
- Typical methods for validation of cleaning procedures
- Design considerations
- Selection of materials
- Recommended method for combustion and quantitative analysis of combustion products of non-metallic materials
- Rationale
- Bibliography
This standard was drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 15001 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 6, Medical gas systems.
This second edition cancels and replaces the first edition (ISO 15001:2003), subclauses of which have been technically revised.
Oxygen, pure or mixed with other medical gases, is widely used in medical applications. Because patients and clinical personnel are often in close proximity to devices used with oxygen, the risk of serious injury is high if a fire occurs in an oxygen-enriched atmosphere. A common cause of fire is the heat produced by adiabatic compression, and the presence of hydrocarbon and particulate contaminants facilitates ignition. Some combustion products, especially some non-metals (e.g. plastics, elastomers and lubricants) are toxic and thus patients remote from that equipment and who are receiving oxygen from a medical gas pipeline system might be injured when a problem occurs. Other equipment which is in close proximity to the equipment using oxygen, or that utilizes oxygen as its source of power, can be damaged or fail to function properly if there is a problem with the oxygen equipment.
Reduction or avoidance of these risks depends on the choice of appropriate materials, cleaning procedures and correct design and construction of equipment so that it is compatible with oxygen under the conditions of use.
BS EN ISO 15001 gives recommendations for the selection of materials and the cleaning of components made from them, for use in oxygen and oxygen-enriched atmospheres.
It is expected that particular device standards will make reference to this horizontal International Standard and may, if appropriate, strengthen these minimum requirements.
Particular device standards may specify that some requirements of this International Standard may apply for medical gases other than oxygen.
BS EN ISO 15001 has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC.
