BS EN ISO 15001 is the standards for anaesthetic and respiratory equipment available in the BSI shop

BS EN ISO 15001:2010

Anaesthetic and respiratory equipment. Compatibility with oxygen

Status : Revised, Withdrawn   Published : September 2010 Replaced By : BS EN ISO 15001:2011

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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.




Standard NumberBS EN ISO 15001:2010
TitleAnaesthetic and respiratory equipment. Compatibility with oxygen
StatusRevised, Withdrawn
Publication Date30 September 2010
Withdrawn Date30 November 2011
Normative References(Required to achieve compliance to this standard)ISO 14971
Informative References(Provided for Information)ISO 4135, ISO 7291, ISO 10297, ISO 10298:2010, ISO 10524-1, ISO 10524-2, ISO 10524-3, ISO 11114-1, ISO 11114-3, ISO 4589-1, ISO 4589-2:1996, ISO 4589-3, EN 13348, ASTM B819-00, ASTM D2863-00, ASTM G63-99, ASTM G72-01, ASTM G74-08, ASTM G86-98a, ASTM G88-05, ASTM G93-03, ASTM G94-05, ASTM G114-07, ASTM G120-01, ASTM G122-96, ASTM G124-95, ASTM G125-00, ASTM G126-00, ASTM G127-95, ASTM G128-02, ASTM G131-96, ASTM G144-01, ASTM G145-08, ASTM G175-03, BS 6869:1987, CGA V-9:2009, EIGA IGC 33/06/E, NFPA 53:2004, ISO 19701, IEC 60601-1:2009, ISO 21969, 93/42/EEC, ASTM STP812:1983, ASTM STP910:1986, ASTM STP986:1988, ASTM STP1040:1989, ASTM STP1111:1991, ASTM STP1197:1993, ASTM STP1267:1995, ASTM STP1319:1997, ASTM STP1395:2000, ASTM STP1454:2003, ASTM STP1479:2006
Replaced ByBS EN ISO 15001:2011
ReplacesBS EN ISO 15001:2004
International RelationshipsEN ISO 15001:2010,ISO 15001:2010
DescriptorsAnaesthesiology, Anaesthetic equipment, Breathing apparatus, Respirators, Oxygen masks, Compatibility, Oxygen, Hygiene, Ignitability, Fire risks, Toxicity, Cleaning, Risk assessment, Medical equipment
ICS11.040.10
Title in FrenchMatériel d'anesthésie et de réanimation respiratoire. Compatibilité avec l'oxygène
Title in GermanAnästhesie- und Beatmungsgeräte. Verträglichkeit mit Sauerstoff
CommitteeCH/121/6
ISBN978 0 580 61769 0
PublisherBSI
FormatA4
DeliveryNo
Pages52
File Size839.5 KB
Price£260.00


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