BS EN ISO 5364:2016 pdf free
BS EN ISO 5364:2016 pdf free.Anaesthetic and respiratory equipment一Oropharyngeal airways
This Annex provides a concise rationale for the important requirements of BS EN ISO 5364 and is intended for use by those who are familiar with the subject of this International Standard, but who have not participated in its development. An understanding of the reasons for the main requirements is considered essential for its proper application. Furthermore, as clinical practices and technologies change, it is believed that rationales for the present requirements will facilitate any revisions of this International Standard necessitated by those developments.
The subclauses in this Annex have been numbered to correspond to the subclauses in this International Standard to which they refer. The numbering is, therefore, not consecutive.
This legibility requirement is adapted from EN 980:2008, 4.2.5.
The subcommittee agreed that a unique colour for each designated size was important for patient safety. The subcommittee was aware that existing colour codes vary by manufacturer, making rapid identification and selection of the proper size for the patient very difficult and confusing. Current manufacturers were surveyed and the following chart of various colour codes in use in 2013 was developed. The colours mandated in this standard were then selected by determining those most commonly used by manufacturers with an aim to reduce the burden of change by the manufacturers and to reduce confusion by the users who have become accustomed to the current colour designations.
Tables A.1 and A.2 compare size colour code identified in the survey of 13 airway manufacturers to the size colour code selected for this International Standard.
Unless intended and marked for single use, oropharyngeal airways and any marking materials used on oropharyngeal airways should be resistant to deterioration by methods of cleaning, disinfection and sterilization recommended by the manufacturer.
The recommended method or methods of sterilization should not produce changes in the materials which will compromise the biological safety of the oropharyngeal airway (see Clause 5).
Oropharyngeal airways and any marking materials used on oropharyngeal airways under normal conditions of use should be resistant to deterioration by clinically used concentrations of anaesthetic vapours and gases and commonly used water-soluble lubricants and topical anaesthetics.BS EN ISO 5364 pdf download.
