Safe and reliable equipment is essential for patient safety and quality of care in anaesthesia and respiratory medicine.
If you design, develop, produce, install or service any medical device you need to comply with the requirements set out in the relevant European Directives:
Standardization in the field of anaesthetic and respiratory equipment involves the production of a wide variety of standards in relation to anaesthetic machines, lung ventilators and medical gas supply and breathing systems. Clinicians, government agencies and representatives of manufacturers work together within BSI committees to produce a body of international standards which will serve to facilitate the exchange of goods and services by eliminating technical barriers while taking account of health and safety issues (for both patient and operator) and environmental protection. The committees in this area are currently heavily involved in the production of a series of ISO 8835 standards which when complete will provide a truly international standard for anaesthetic equipment.
BS EN 60601-2-12 sets the minimum requirements that should be met by every critical care ventilator designed after the publication of this standard. The standard specifies the safety requirements for ventilators intended for use in critical care settings.
 BS EN ISO 7396-1:2007
Medical gas pipeline systems. Pipeline systems for compressed medical gases and vacuum |
BS EN ISO 7396-2:2007
Medical gas pipeline systems. Anaesthetic gas scavenging disposal systems |
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BS EN ISO 10524-2:2006
Pressure regulators for use with medical gases. Manifold and line pressure regulators |
BS EN 60601-2-12:2006
Medical electrical equipment. Particular requirements for the safety of lung ventilators. Critical care ventilators |
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